User login
For women with RA, small-joint surgery rate nearly twice that of men
SAN DIEGO – but the rate of small-joint procedures is declining for both sexes. However, no differences in rates of large-joint procedures between sexes were observed during the same time period.
Those are key findings from a retrospective study which set out to determine if there are sex differences in the incidence and trends of large- versus small-joint surgery rates in rheumatoid arthritis over time. “Why is orthopedic surgery important to rheumatology? The main reason is because it’s a surrogate for failed medical management,” lead study author Michael D. Richter, MD, said at the annual meeting of the American College of Rheumatology.
Dr. Richter, an internal medicine resident at Mayo Clinic, Rochester, Minn., said that women with RA generally present with more severe symptoms and higher rates of disability, while men have a better treatment response and a higher remission rate. For example, results from the multinational Quantitative Standard Monitoring of Patients with RA study found that remission rates were around 30% in men and 17% in women (Arthritis Res Ther. 2009;11[1]:R7). “However, a lot of these studies are criticized because it’s thought that gender can play a role in the disease measures,” he said. “By looking at joint surgery we have an objective outcome, and we can look at differences in treatment efficacy.”
Dr. Richter and his associates drew from the Rochester Epidemiology Project to identify 1,077 patients from Olmstead County, Minn., who fulfilled ACR criteria for RA between 1980 and 2013, and who were followed up until death, migration, or July 1, 2016. They classified surgeries as small joint (wrist, hand, or foot) or large joint (shoulder, elbow, hip, knee, or ankle). A majority of the patients (70%) were women. Compared with women, men were slightly older at diagnosis (a mean of 58 years vs. 55 years, respectively), were more likely to have a history of smoking (67% vs. 46%), and were more likely to have large-joint swelling upon initial presentation (49% vs. 42%). The mean follow-up was 12 years. No differences between men and women were noted in obesity, inflammatory biomarkers, or seropositivity.
During the study period, 112 patients underwent at least one small-joint surgery, 90 of whom were women (80%). The cumulative incidence of small-joint surgery at 15 years was nearly double that of men: 14.4% vs. 7.6%, respectively (P = .008). “Prior to the year 2000 there were no significant trends in the rate of small-joint surgery but it was more common in women,” he said. “After 2000 there was a significant decline for men and women (P = .002), but no significant difference between sexes.”
At the same time, 204 patients underwent at least one large-joint surgery during the time period, 141 of whom were women (69%). The cumulative incidence of large-joint surgery at 15 years was 20.2% for women and 18.8% for men, which was statistically similar (P = .55). “We saw no significant change over time in the rate of large-joint surgery from 1980 to 2016,” Dr. Richter said. “This is in contrast to what we see in the general population, where orthopedic procedures for osteoarthritis are more common.”
He acknowledged certain limitations of the study, including its retrospective design and the fact that the researchers were unable to include specific surgical indications in the analysis. “This becomes particularly important for the large-joint procedures,” he said. “We don’t know if osteoarthritis or chronic inflammatory arthritis is leading to the large-joint procedure.”
The National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute on Aging funded the study. Dr. Richter reported having no financial disclosures.
SAN DIEGO – but the rate of small-joint procedures is declining for both sexes. However, no differences in rates of large-joint procedures between sexes were observed during the same time period.
Those are key findings from a retrospective study which set out to determine if there are sex differences in the incidence and trends of large- versus small-joint surgery rates in rheumatoid arthritis over time. “Why is orthopedic surgery important to rheumatology? The main reason is because it’s a surrogate for failed medical management,” lead study author Michael D. Richter, MD, said at the annual meeting of the American College of Rheumatology.
Dr. Richter, an internal medicine resident at Mayo Clinic, Rochester, Minn., said that women with RA generally present with more severe symptoms and higher rates of disability, while men have a better treatment response and a higher remission rate. For example, results from the multinational Quantitative Standard Monitoring of Patients with RA study found that remission rates were around 30% in men and 17% in women (Arthritis Res Ther. 2009;11[1]:R7). “However, a lot of these studies are criticized because it’s thought that gender can play a role in the disease measures,” he said. “By looking at joint surgery we have an objective outcome, and we can look at differences in treatment efficacy.”
Dr. Richter and his associates drew from the Rochester Epidemiology Project to identify 1,077 patients from Olmstead County, Minn., who fulfilled ACR criteria for RA between 1980 and 2013, and who were followed up until death, migration, or July 1, 2016. They classified surgeries as small joint (wrist, hand, or foot) or large joint (shoulder, elbow, hip, knee, or ankle). A majority of the patients (70%) were women. Compared with women, men were slightly older at diagnosis (a mean of 58 years vs. 55 years, respectively), were more likely to have a history of smoking (67% vs. 46%), and were more likely to have large-joint swelling upon initial presentation (49% vs. 42%). The mean follow-up was 12 years. No differences between men and women were noted in obesity, inflammatory biomarkers, or seropositivity.
During the study period, 112 patients underwent at least one small-joint surgery, 90 of whom were women (80%). The cumulative incidence of small-joint surgery at 15 years was nearly double that of men: 14.4% vs. 7.6%, respectively (P = .008). “Prior to the year 2000 there were no significant trends in the rate of small-joint surgery but it was more common in women,” he said. “After 2000 there was a significant decline for men and women (P = .002), but no significant difference between sexes.”
At the same time, 204 patients underwent at least one large-joint surgery during the time period, 141 of whom were women (69%). The cumulative incidence of large-joint surgery at 15 years was 20.2% for women and 18.8% for men, which was statistically similar (P = .55). “We saw no significant change over time in the rate of large-joint surgery from 1980 to 2016,” Dr. Richter said. “This is in contrast to what we see in the general population, where orthopedic procedures for osteoarthritis are more common.”
He acknowledged certain limitations of the study, including its retrospective design and the fact that the researchers were unable to include specific surgical indications in the analysis. “This becomes particularly important for the large-joint procedures,” he said. “We don’t know if osteoarthritis or chronic inflammatory arthritis is leading to the large-joint procedure.”
The National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute on Aging funded the study. Dr. Richter reported having no financial disclosures.
SAN DIEGO – but the rate of small-joint procedures is declining for both sexes. However, no differences in rates of large-joint procedures between sexes were observed during the same time period.
Those are key findings from a retrospective study which set out to determine if there are sex differences in the incidence and trends of large- versus small-joint surgery rates in rheumatoid arthritis over time. “Why is orthopedic surgery important to rheumatology? The main reason is because it’s a surrogate for failed medical management,” lead study author Michael D. Richter, MD, said at the annual meeting of the American College of Rheumatology.
Dr. Richter, an internal medicine resident at Mayo Clinic, Rochester, Minn., said that women with RA generally present with more severe symptoms and higher rates of disability, while men have a better treatment response and a higher remission rate. For example, results from the multinational Quantitative Standard Monitoring of Patients with RA study found that remission rates were around 30% in men and 17% in women (Arthritis Res Ther. 2009;11[1]:R7). “However, a lot of these studies are criticized because it’s thought that gender can play a role in the disease measures,” he said. “By looking at joint surgery we have an objective outcome, and we can look at differences in treatment efficacy.”
Dr. Richter and his associates drew from the Rochester Epidemiology Project to identify 1,077 patients from Olmstead County, Minn., who fulfilled ACR criteria for RA between 1980 and 2013, and who were followed up until death, migration, or July 1, 2016. They classified surgeries as small joint (wrist, hand, or foot) or large joint (shoulder, elbow, hip, knee, or ankle). A majority of the patients (70%) were women. Compared with women, men were slightly older at diagnosis (a mean of 58 years vs. 55 years, respectively), were more likely to have a history of smoking (67% vs. 46%), and were more likely to have large-joint swelling upon initial presentation (49% vs. 42%). The mean follow-up was 12 years. No differences between men and women were noted in obesity, inflammatory biomarkers, or seropositivity.
During the study period, 112 patients underwent at least one small-joint surgery, 90 of whom were women (80%). The cumulative incidence of small-joint surgery at 15 years was nearly double that of men: 14.4% vs. 7.6%, respectively (P = .008). “Prior to the year 2000 there were no significant trends in the rate of small-joint surgery but it was more common in women,” he said. “After 2000 there was a significant decline for men and women (P = .002), but no significant difference between sexes.”
At the same time, 204 patients underwent at least one large-joint surgery during the time period, 141 of whom were women (69%). The cumulative incidence of large-joint surgery at 15 years was 20.2% for women and 18.8% for men, which was statistically similar (P = .55). “We saw no significant change over time in the rate of large-joint surgery from 1980 to 2016,” Dr. Richter said. “This is in contrast to what we see in the general population, where orthopedic procedures for osteoarthritis are more common.”
He acknowledged certain limitations of the study, including its retrospective design and the fact that the researchers were unable to include specific surgical indications in the analysis. “This becomes particularly important for the large-joint procedures,” he said. “We don’t know if osteoarthritis or chronic inflammatory arthritis is leading to the large-joint procedure.”
The National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute on Aging funded the study. Dr. Richter reported having no financial disclosures.
AT ACR 2017
Key clinical point: Women with RA had a higher rate of small-joint surgery, compared with men.
Major finding: The cumulative incidence of small-joint surgery was significantly higher among women, compared with men (14.4% vs. 7.6%, respectively), but there were no differences between sexes in the rates of large-joint surgery.
Study details: A retrospective, population-based study of 1,077 patients with RA.
Disclosures: The National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute on Aging funded the study. Dr. Richter reported having no financial disclosures.
Improving the risk assessment of patients with acute pulmonary embolism
Who doesn’t like alphabet soup? Those noodles shaped as letters floating in a delicious hot broth serve as an educational way for young children to play with their food. Of course, this commentary is not about warm food suitable for a cold day but, instead, about another notion of alphabet soup – a metaphor for physicians’ failure to optimally utilize our alphabet soup of venous thromboembolism studies.
The medical literature that has studied the incidence, prevalence, diagnosis, and management of acute pulmonary embolism (PE) is vast. Yes, we have our own PE “alphabet soup” – a “hodgepodge especially of initials,” according to the Merriam-Webster Dictionary. ICOPER (International Cooperative Pulmonary Embolism Registry) and RIETE (Computerized Registry of Patients with Venous Thromboembolism) help estimate prevalence of the disease and indicate high-risk groups. PESI (Pulmonary Embolism Severity Index) and PERC (Pulmonary Embolism Rule-Out Criteria) provide useful predictive information prior to proceeding with diagnostic testing for PE. The PEITHO (Pulmonary Embolism Thrombolysis), MOPETT (Moderate Pulmonary Embolism Treated with Thrombolysis), and PERFECT (Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis) studies help to guide the decision to administer fibrinolytic therapy, particularly in the cases of so-called submassive or intermediate-risk PE.
And yet, in a study published in Hospital Practice (2017 Aug 30. doi: 10.1080/21548331.2017.1372033), my colleagues and I showed that, to a large extent, physicians admitting patients to the hospital between 2011 and 2013 for acute PE failed to order or perform even the most basic noninvasive testing on their patients, despite strong recommendations for such testing from both the 2011 American Heart Association (AHA) and the 2014 European Society of Cardiology as part of the risk assessment of acute PE.
At the time of the patients’ PE admissions, the 2011 AHA statement already had been published, and it was recognized that medical and interventional therapies needed to be appropriate to the characteristics of the patient with PE. Specifically, in order to determine a prognosis, assessment of right heart strain with an echocardiogram, ECG, and brain natriuretic peptide testing was recommended. For similar reasons, a serum troponin test was recommended to evaluate any myocardial necrosis.
While the 2011 AHA statement was based on a preponderance of evidence-based medicine, our research suggests that physicians may be doing a suboptimal job of collecting the necessary data to manage our acute PE patients. In defense of those physicians we evaluated, these data were collected just before the European Society of Cardiology disseminated their recommendations for risk stratification in 2014. The PEITHO, MOPETT, and PERFECT findings – though already presented at medical meetings in part – were not published in scientific journals in full until 2013 or thereafter.
Nevertheless, I believe these findings illustrate the merits of the Pulmonary Embolism Response Team (PERT) concept. As the data we studied suggest, not only might hospital-based physicians inadequately assess the severity of patients’ PE, but they also may fail to ask for consultations from the specialists who could be most useful in assisting in the proper evaluation and management of these patients. PERTs ensure that every patient admitted to the hospital with the diagnosis of PE will be assessed by a team of physicians with the expertise and professional interest in best managing these patients.
The expectation is that, with the institution of a PERT at each hospital, a more complete evaluation of patients’ PE may lead to optimal management and, thereby, to improved short- and long-term outcomes. Also, we should not assume that a greater degree of expertise and imaging capabilities at an academic university hospital translates to a more complete evaluation of PE; our research shows that this is not necessarily the case. PERTs may help mobilize resources that are underutilized even at academic university hospitals. Those interested in learning more about PERTs may contact the National PERT Consortium via email at contact@pertconsortium.org or go online to www.pertconsortium.org.
Rather than wallow in an alphabet soup of acronyms, let us place our acronymic clinical PE trials to good use. Gather the appropriate clinical data, consult experts in pulmonary embolism, and stratify patients admitted to the hospital with acute PE so that we can manage the expectations of short- and long-term outcomes.
When he became president in 1933, Franklin D. Roosevelt sought to lift the United States from the Great Depression, in part with a New Deal “alphabet soup” of programs. Like FDR, let us put our own alphabet soup – of PE studies and position statements – to good use: to work for the good of people hospitalized with acute pulmonary embolism.
Dr. Scharf is medical director of pulmonary outpatient services at the Jane and Leonard Korman Respiratory Institute at Jefferson Medical College, Philadelphia. He is also director of the pulmonary vascular disease program at Jefferson.
Who doesn’t like alphabet soup? Those noodles shaped as letters floating in a delicious hot broth serve as an educational way for young children to play with their food. Of course, this commentary is not about warm food suitable for a cold day but, instead, about another notion of alphabet soup – a metaphor for physicians’ failure to optimally utilize our alphabet soup of venous thromboembolism studies.
The medical literature that has studied the incidence, prevalence, diagnosis, and management of acute pulmonary embolism (PE) is vast. Yes, we have our own PE “alphabet soup” – a “hodgepodge especially of initials,” according to the Merriam-Webster Dictionary. ICOPER (International Cooperative Pulmonary Embolism Registry) and RIETE (Computerized Registry of Patients with Venous Thromboembolism) help estimate prevalence of the disease and indicate high-risk groups. PESI (Pulmonary Embolism Severity Index) and PERC (Pulmonary Embolism Rule-Out Criteria) provide useful predictive information prior to proceeding with diagnostic testing for PE. The PEITHO (Pulmonary Embolism Thrombolysis), MOPETT (Moderate Pulmonary Embolism Treated with Thrombolysis), and PERFECT (Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis) studies help to guide the decision to administer fibrinolytic therapy, particularly in the cases of so-called submassive or intermediate-risk PE.
And yet, in a study published in Hospital Practice (2017 Aug 30. doi: 10.1080/21548331.2017.1372033), my colleagues and I showed that, to a large extent, physicians admitting patients to the hospital between 2011 and 2013 for acute PE failed to order or perform even the most basic noninvasive testing on their patients, despite strong recommendations for such testing from both the 2011 American Heart Association (AHA) and the 2014 European Society of Cardiology as part of the risk assessment of acute PE.
At the time of the patients’ PE admissions, the 2011 AHA statement already had been published, and it was recognized that medical and interventional therapies needed to be appropriate to the characteristics of the patient with PE. Specifically, in order to determine a prognosis, assessment of right heart strain with an echocardiogram, ECG, and brain natriuretic peptide testing was recommended. For similar reasons, a serum troponin test was recommended to evaluate any myocardial necrosis.
While the 2011 AHA statement was based on a preponderance of evidence-based medicine, our research suggests that physicians may be doing a suboptimal job of collecting the necessary data to manage our acute PE patients. In defense of those physicians we evaluated, these data were collected just before the European Society of Cardiology disseminated their recommendations for risk stratification in 2014. The PEITHO, MOPETT, and PERFECT findings – though already presented at medical meetings in part – were not published in scientific journals in full until 2013 or thereafter.
Nevertheless, I believe these findings illustrate the merits of the Pulmonary Embolism Response Team (PERT) concept. As the data we studied suggest, not only might hospital-based physicians inadequately assess the severity of patients’ PE, but they also may fail to ask for consultations from the specialists who could be most useful in assisting in the proper evaluation and management of these patients. PERTs ensure that every patient admitted to the hospital with the diagnosis of PE will be assessed by a team of physicians with the expertise and professional interest in best managing these patients.
The expectation is that, with the institution of a PERT at each hospital, a more complete evaluation of patients’ PE may lead to optimal management and, thereby, to improved short- and long-term outcomes. Also, we should not assume that a greater degree of expertise and imaging capabilities at an academic university hospital translates to a more complete evaluation of PE; our research shows that this is not necessarily the case. PERTs may help mobilize resources that are underutilized even at academic university hospitals. Those interested in learning more about PERTs may contact the National PERT Consortium via email at contact@pertconsortium.org or go online to www.pertconsortium.org.
Rather than wallow in an alphabet soup of acronyms, let us place our acronymic clinical PE trials to good use. Gather the appropriate clinical data, consult experts in pulmonary embolism, and stratify patients admitted to the hospital with acute PE so that we can manage the expectations of short- and long-term outcomes.
When he became president in 1933, Franklin D. Roosevelt sought to lift the United States from the Great Depression, in part with a New Deal “alphabet soup” of programs. Like FDR, let us put our own alphabet soup – of PE studies and position statements – to good use: to work for the good of people hospitalized with acute pulmonary embolism.
Dr. Scharf is medical director of pulmonary outpatient services at the Jane and Leonard Korman Respiratory Institute at Jefferson Medical College, Philadelphia. He is also director of the pulmonary vascular disease program at Jefferson.
Who doesn’t like alphabet soup? Those noodles shaped as letters floating in a delicious hot broth serve as an educational way for young children to play with their food. Of course, this commentary is not about warm food suitable for a cold day but, instead, about another notion of alphabet soup – a metaphor for physicians’ failure to optimally utilize our alphabet soup of venous thromboembolism studies.
The medical literature that has studied the incidence, prevalence, diagnosis, and management of acute pulmonary embolism (PE) is vast. Yes, we have our own PE “alphabet soup” – a “hodgepodge especially of initials,” according to the Merriam-Webster Dictionary. ICOPER (International Cooperative Pulmonary Embolism Registry) and RIETE (Computerized Registry of Patients with Venous Thromboembolism) help estimate prevalence of the disease and indicate high-risk groups. PESI (Pulmonary Embolism Severity Index) and PERC (Pulmonary Embolism Rule-Out Criteria) provide useful predictive information prior to proceeding with diagnostic testing for PE. The PEITHO (Pulmonary Embolism Thrombolysis), MOPETT (Moderate Pulmonary Embolism Treated with Thrombolysis), and PERFECT (Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis) studies help to guide the decision to administer fibrinolytic therapy, particularly in the cases of so-called submassive or intermediate-risk PE.
And yet, in a study published in Hospital Practice (2017 Aug 30. doi: 10.1080/21548331.2017.1372033), my colleagues and I showed that, to a large extent, physicians admitting patients to the hospital between 2011 and 2013 for acute PE failed to order or perform even the most basic noninvasive testing on their patients, despite strong recommendations for such testing from both the 2011 American Heart Association (AHA) and the 2014 European Society of Cardiology as part of the risk assessment of acute PE.
At the time of the patients’ PE admissions, the 2011 AHA statement already had been published, and it was recognized that medical and interventional therapies needed to be appropriate to the characteristics of the patient with PE. Specifically, in order to determine a prognosis, assessment of right heart strain with an echocardiogram, ECG, and brain natriuretic peptide testing was recommended. For similar reasons, a serum troponin test was recommended to evaluate any myocardial necrosis.
While the 2011 AHA statement was based on a preponderance of evidence-based medicine, our research suggests that physicians may be doing a suboptimal job of collecting the necessary data to manage our acute PE patients. In defense of those physicians we evaluated, these data were collected just before the European Society of Cardiology disseminated their recommendations for risk stratification in 2014. The PEITHO, MOPETT, and PERFECT findings – though already presented at medical meetings in part – were not published in scientific journals in full until 2013 or thereafter.
Nevertheless, I believe these findings illustrate the merits of the Pulmonary Embolism Response Team (PERT) concept. As the data we studied suggest, not only might hospital-based physicians inadequately assess the severity of patients’ PE, but they also may fail to ask for consultations from the specialists who could be most useful in assisting in the proper evaluation and management of these patients. PERTs ensure that every patient admitted to the hospital with the diagnosis of PE will be assessed by a team of physicians with the expertise and professional interest in best managing these patients.
The expectation is that, with the institution of a PERT at each hospital, a more complete evaluation of patients’ PE may lead to optimal management and, thereby, to improved short- and long-term outcomes. Also, we should not assume that a greater degree of expertise and imaging capabilities at an academic university hospital translates to a more complete evaluation of PE; our research shows that this is not necessarily the case. PERTs may help mobilize resources that are underutilized even at academic university hospitals. Those interested in learning more about PERTs may contact the National PERT Consortium via email at contact@pertconsortium.org or go online to www.pertconsortium.org.
Rather than wallow in an alphabet soup of acronyms, let us place our acronymic clinical PE trials to good use. Gather the appropriate clinical data, consult experts in pulmonary embolism, and stratify patients admitted to the hospital with acute PE so that we can manage the expectations of short- and long-term outcomes.
When he became president in 1933, Franklin D. Roosevelt sought to lift the United States from the Great Depression, in part with a New Deal “alphabet soup” of programs. Like FDR, let us put our own alphabet soup – of PE studies and position statements – to good use: to work for the good of people hospitalized with acute pulmonary embolism.
Dr. Scharf is medical director of pulmonary outpatient services at the Jane and Leonard Korman Respiratory Institute at Jefferson Medical College, Philadelphia. He is also director of the pulmonary vascular disease program at Jefferson.
How hospitalists can focus on health equity
A decade ago, most hospitalists and hospital leaders were not thinking about health equity, let alone discussing it.
“It used to be we could say: ‘We saved your life but everything else is beyond our control,’ ” said Nick Fitterman, MD, FACP, SFHM, vice chair of Hospital Medicine at Northwell Health in New York, and associate professor of medicine at Hofstra Northwell School of Medicine and Long Island Jewish Medical Center.
But today?
”We have a better understanding that what affects the health of most of our patients is what happens outside the four walls of the hospital,” he said. “Now, we can work with case managers and community-based organizations to help address housing and food. We can at least steer our patients to resources and help them with the social determinants of their health.”
A report recently published by the University of California, San Francisco, and the Robert Wood Johnson Foundation (RWJF) takes on the definition of health equity.1 Because, as one of the report’s authors, Paula Braveman, MD, MPH, professor of Family and Community Medicine and director of the Center on Social Disparities in Health at UCSF, argued in a Health Affairs blog post in June 2017: “Clarity is particularly important because pursuing equity often involves engaging diverse audiences and stakeholders, each with their own constituents, beliefs, and agendas. And in an era of data, a sound definition is crucial to shape the benchmarks against which progress can be measured.”
Measurement is an unavoidable aspect of the practice of medicine in the 21st century and both Dr. Fitterman and Dr. Smothers say hospitals must start focusing on the nonmedical factors that influence health to find success.
“Payment reform is forcing delivery reform,” Dr. Fitterman said.
A report from the National Academies of Sciences, Engineering, and Medicine estimates that racial health disparities alone – not including other marginalized groups – could cost health insurers as much as $337 billion between 2009 and 2018.2 “Hospitals and hospitalists have to focus on health disparities in order to address the multitude of chronic medical conditions they treat,” said Dr. Smothers.
For the purposes of measurement, the authors of the RWJF report conclude that “health equity means reducing and ultimately eliminating disparities in health and its determinants that adversely affect excluded or marginalized groups.” The report attempts to define health equity as a means of specifically addressing it.
“Population health means taking care of the wider population, in terms of health and cost,” said Dr. Fitterman. “But if you’re just looking at the average health of a population you could still be missing pockets of disparity, since there will be pockets that excel and pockets of disparity but the average looks good. If we’re not careful how we measure it, we may leave some groups behind.”
Achieving health equity, the RWJF report says, requires removing the “obstacles to health such as poverty, discrimination, and their consequences, including powerlessness and lack of access to good jobs with fair pay, quality education and housing, safe environments, and health care.” Health equity means that everyone must have “a fair and just opportunity to be as healthy as possible.”
It lays out four “key steps” to achieve health equity: 1. Identify important health disparities; 2. Change and implement policies, laws, systems, environments, and practices to reduce inequities in the opportunities and resources needed to be healthier; 3. Evaluate and monitor efforts using short- and long-term measures; and 4. Reassess strategies in light of process and outcomes, plan next steps.
Everyone can be a part of the solutions to address health disparities, Dr. Fitterman said. He was not involved in the report. For hospitalists interested in addressing health equity, Dr. Braveman had two recommendations:
• Choose to practice at a hospital that serves large numbers of socially disadvantaged people;
• Put particular effort into helping the most socially disadvantaged patients in their hospitals.
This should include understanding the conditions that bring disadvantaged people to the hospital in disproportionate numbers, Dr. Braveman said, and getting involved in initiatives intended to address them. For example, after observing that disproportionate numbers of poor kids are hospitalized with asthma, hospitalists might connect with community groups that can help address pest abatement in low-income housing.
Health equity efforts should not just focus on socioeconomically or racially disadvantaged groups either, Dr. Braveman and Dr. Fitterman argue. They must also address others who are marginalized, like patients who are disabled, elderly, obese, non–English speaking, or gender nonconforming.
Dr. Fitterman said his hospital leadership has made health equity a priority and believes successful health equity practices involve good leadership, becoming aware of and addressing unconscious bias, and efforts to address the social determinants that can cut through health disparities.
“The focus of our last leadership retreat was diversity and health disparities,” Dr. Fitterman said. “It starts at the top down. I bring that to our faculty and site directors: everyone takes an online test to raise their awareness of unconscious bias.”
Dr. Smothers serves on the board of the Center for Health Equity and Wellness at Adventist HealthCare, which works to improve access to “culturally appropriate care, and provides community wellness outreach and education.” He said that, in addition to programs at the Center which address disparities, his hospital has also established teams of doctors, nurses, case managers, and transitional care nurses to help redirect patients to “more appropriate, less costly services, such as primary care, urgent care, home care, and subacute care,” when it is in the patient’s best interest.
Not only are Adventist’s hospitalists aware of community resources available to their patients, they are also culturally diverse, Dr. Smothers said, noting that they are “well equipped to manage our diverse patient population, including those who lack adequate health care.”
Additionally, Dr. Smothers said: “We engage our hospitalists in care coordination, encouraging them to make recommendations on alternative treatment locations and/or options at the point of entry.” And all admitted patients with chronic conditions are provided with a month’s supply of medication and schedule transportation for their follow-up appointment upon discharge.
“We need to inquire about social determinants that may prohibit our success with our patients,” said Dr. Fitterman. “You are not always going to be able to fix it, but it doesn’t mean you shouldn’t try.”
References
1. Braveman P, et al. What is health equity? And what difference does a definition make? Robert Wood Johnson Foundation. Published May 2017. Accessed July 15, 2017.
2. Communities in Action: Pathways to Health Equity. National Academies of Sciences, Engineering and Medicine. Published Jan. 11, 2017. Accessed July 15, 2017.
A decade ago, most hospitalists and hospital leaders were not thinking about health equity, let alone discussing it.
“It used to be we could say: ‘We saved your life but everything else is beyond our control,’ ” said Nick Fitterman, MD, FACP, SFHM, vice chair of Hospital Medicine at Northwell Health in New York, and associate professor of medicine at Hofstra Northwell School of Medicine and Long Island Jewish Medical Center.
But today?
”We have a better understanding that what affects the health of most of our patients is what happens outside the four walls of the hospital,” he said. “Now, we can work with case managers and community-based organizations to help address housing and food. We can at least steer our patients to resources and help them with the social determinants of their health.”
A report recently published by the University of California, San Francisco, and the Robert Wood Johnson Foundation (RWJF) takes on the definition of health equity.1 Because, as one of the report’s authors, Paula Braveman, MD, MPH, professor of Family and Community Medicine and director of the Center on Social Disparities in Health at UCSF, argued in a Health Affairs blog post in June 2017: “Clarity is particularly important because pursuing equity often involves engaging diverse audiences and stakeholders, each with their own constituents, beliefs, and agendas. And in an era of data, a sound definition is crucial to shape the benchmarks against which progress can be measured.”
Measurement is an unavoidable aspect of the practice of medicine in the 21st century and both Dr. Fitterman and Dr. Smothers say hospitals must start focusing on the nonmedical factors that influence health to find success.
“Payment reform is forcing delivery reform,” Dr. Fitterman said.
A report from the National Academies of Sciences, Engineering, and Medicine estimates that racial health disparities alone – not including other marginalized groups – could cost health insurers as much as $337 billion between 2009 and 2018.2 “Hospitals and hospitalists have to focus on health disparities in order to address the multitude of chronic medical conditions they treat,” said Dr. Smothers.
For the purposes of measurement, the authors of the RWJF report conclude that “health equity means reducing and ultimately eliminating disparities in health and its determinants that adversely affect excluded or marginalized groups.” The report attempts to define health equity as a means of specifically addressing it.
“Population health means taking care of the wider population, in terms of health and cost,” said Dr. Fitterman. “But if you’re just looking at the average health of a population you could still be missing pockets of disparity, since there will be pockets that excel and pockets of disparity but the average looks good. If we’re not careful how we measure it, we may leave some groups behind.”
Achieving health equity, the RWJF report says, requires removing the “obstacles to health such as poverty, discrimination, and their consequences, including powerlessness and lack of access to good jobs with fair pay, quality education and housing, safe environments, and health care.” Health equity means that everyone must have “a fair and just opportunity to be as healthy as possible.”
It lays out four “key steps” to achieve health equity: 1. Identify important health disparities; 2. Change and implement policies, laws, systems, environments, and practices to reduce inequities in the opportunities and resources needed to be healthier; 3. Evaluate and monitor efforts using short- and long-term measures; and 4. Reassess strategies in light of process and outcomes, plan next steps.
Everyone can be a part of the solutions to address health disparities, Dr. Fitterman said. He was not involved in the report. For hospitalists interested in addressing health equity, Dr. Braveman had two recommendations:
• Choose to practice at a hospital that serves large numbers of socially disadvantaged people;
• Put particular effort into helping the most socially disadvantaged patients in their hospitals.
This should include understanding the conditions that bring disadvantaged people to the hospital in disproportionate numbers, Dr. Braveman said, and getting involved in initiatives intended to address them. For example, after observing that disproportionate numbers of poor kids are hospitalized with asthma, hospitalists might connect with community groups that can help address pest abatement in low-income housing.
Health equity efforts should not just focus on socioeconomically or racially disadvantaged groups either, Dr. Braveman and Dr. Fitterman argue. They must also address others who are marginalized, like patients who are disabled, elderly, obese, non–English speaking, or gender nonconforming.
Dr. Fitterman said his hospital leadership has made health equity a priority and believes successful health equity practices involve good leadership, becoming aware of and addressing unconscious bias, and efforts to address the social determinants that can cut through health disparities.
“The focus of our last leadership retreat was diversity and health disparities,” Dr. Fitterman said. “It starts at the top down. I bring that to our faculty and site directors: everyone takes an online test to raise their awareness of unconscious bias.”
Dr. Smothers serves on the board of the Center for Health Equity and Wellness at Adventist HealthCare, which works to improve access to “culturally appropriate care, and provides community wellness outreach and education.” He said that, in addition to programs at the Center which address disparities, his hospital has also established teams of doctors, nurses, case managers, and transitional care nurses to help redirect patients to “more appropriate, less costly services, such as primary care, urgent care, home care, and subacute care,” when it is in the patient’s best interest.
Not only are Adventist’s hospitalists aware of community resources available to their patients, they are also culturally diverse, Dr. Smothers said, noting that they are “well equipped to manage our diverse patient population, including those who lack adequate health care.”
Additionally, Dr. Smothers said: “We engage our hospitalists in care coordination, encouraging them to make recommendations on alternative treatment locations and/or options at the point of entry.” And all admitted patients with chronic conditions are provided with a month’s supply of medication and schedule transportation for their follow-up appointment upon discharge.
“We need to inquire about social determinants that may prohibit our success with our patients,” said Dr. Fitterman. “You are not always going to be able to fix it, but it doesn’t mean you shouldn’t try.”
References
1. Braveman P, et al. What is health equity? And what difference does a definition make? Robert Wood Johnson Foundation. Published May 2017. Accessed July 15, 2017.
2. Communities in Action: Pathways to Health Equity. National Academies of Sciences, Engineering and Medicine. Published Jan. 11, 2017. Accessed July 15, 2017.
A decade ago, most hospitalists and hospital leaders were not thinking about health equity, let alone discussing it.
“It used to be we could say: ‘We saved your life but everything else is beyond our control,’ ” said Nick Fitterman, MD, FACP, SFHM, vice chair of Hospital Medicine at Northwell Health in New York, and associate professor of medicine at Hofstra Northwell School of Medicine and Long Island Jewish Medical Center.
But today?
”We have a better understanding that what affects the health of most of our patients is what happens outside the four walls of the hospital,” he said. “Now, we can work with case managers and community-based organizations to help address housing and food. We can at least steer our patients to resources and help them with the social determinants of their health.”
A report recently published by the University of California, San Francisco, and the Robert Wood Johnson Foundation (RWJF) takes on the definition of health equity.1 Because, as one of the report’s authors, Paula Braveman, MD, MPH, professor of Family and Community Medicine and director of the Center on Social Disparities in Health at UCSF, argued in a Health Affairs blog post in June 2017: “Clarity is particularly important because pursuing equity often involves engaging diverse audiences and stakeholders, each with their own constituents, beliefs, and agendas. And in an era of data, a sound definition is crucial to shape the benchmarks against which progress can be measured.”
Measurement is an unavoidable aspect of the practice of medicine in the 21st century and both Dr. Fitterman and Dr. Smothers say hospitals must start focusing on the nonmedical factors that influence health to find success.
“Payment reform is forcing delivery reform,” Dr. Fitterman said.
A report from the National Academies of Sciences, Engineering, and Medicine estimates that racial health disparities alone – not including other marginalized groups – could cost health insurers as much as $337 billion between 2009 and 2018.2 “Hospitals and hospitalists have to focus on health disparities in order to address the multitude of chronic medical conditions they treat,” said Dr. Smothers.
For the purposes of measurement, the authors of the RWJF report conclude that “health equity means reducing and ultimately eliminating disparities in health and its determinants that adversely affect excluded or marginalized groups.” The report attempts to define health equity as a means of specifically addressing it.
“Population health means taking care of the wider population, in terms of health and cost,” said Dr. Fitterman. “But if you’re just looking at the average health of a population you could still be missing pockets of disparity, since there will be pockets that excel and pockets of disparity but the average looks good. If we’re not careful how we measure it, we may leave some groups behind.”
Achieving health equity, the RWJF report says, requires removing the “obstacles to health such as poverty, discrimination, and their consequences, including powerlessness and lack of access to good jobs with fair pay, quality education and housing, safe environments, and health care.” Health equity means that everyone must have “a fair and just opportunity to be as healthy as possible.”
It lays out four “key steps” to achieve health equity: 1. Identify important health disparities; 2. Change and implement policies, laws, systems, environments, and practices to reduce inequities in the opportunities and resources needed to be healthier; 3. Evaluate and monitor efforts using short- and long-term measures; and 4. Reassess strategies in light of process and outcomes, plan next steps.
Everyone can be a part of the solutions to address health disparities, Dr. Fitterman said. He was not involved in the report. For hospitalists interested in addressing health equity, Dr. Braveman had two recommendations:
• Choose to practice at a hospital that serves large numbers of socially disadvantaged people;
• Put particular effort into helping the most socially disadvantaged patients in their hospitals.
This should include understanding the conditions that bring disadvantaged people to the hospital in disproportionate numbers, Dr. Braveman said, and getting involved in initiatives intended to address them. For example, after observing that disproportionate numbers of poor kids are hospitalized with asthma, hospitalists might connect with community groups that can help address pest abatement in low-income housing.
Health equity efforts should not just focus on socioeconomically or racially disadvantaged groups either, Dr. Braveman and Dr. Fitterman argue. They must also address others who are marginalized, like patients who are disabled, elderly, obese, non–English speaking, or gender nonconforming.
Dr. Fitterman said his hospital leadership has made health equity a priority and believes successful health equity practices involve good leadership, becoming aware of and addressing unconscious bias, and efforts to address the social determinants that can cut through health disparities.
“The focus of our last leadership retreat was diversity and health disparities,” Dr. Fitterman said. “It starts at the top down. I bring that to our faculty and site directors: everyone takes an online test to raise their awareness of unconscious bias.”
Dr. Smothers serves on the board of the Center for Health Equity and Wellness at Adventist HealthCare, which works to improve access to “culturally appropriate care, and provides community wellness outreach and education.” He said that, in addition to programs at the Center which address disparities, his hospital has also established teams of doctors, nurses, case managers, and transitional care nurses to help redirect patients to “more appropriate, less costly services, such as primary care, urgent care, home care, and subacute care,” when it is in the patient’s best interest.
Not only are Adventist’s hospitalists aware of community resources available to their patients, they are also culturally diverse, Dr. Smothers said, noting that they are “well equipped to manage our diverse patient population, including those who lack adequate health care.”
Additionally, Dr. Smothers said: “We engage our hospitalists in care coordination, encouraging them to make recommendations on alternative treatment locations and/or options at the point of entry.” And all admitted patients with chronic conditions are provided with a month’s supply of medication and schedule transportation for their follow-up appointment upon discharge.
“We need to inquire about social determinants that may prohibit our success with our patients,” said Dr. Fitterman. “You are not always going to be able to fix it, but it doesn’t mean you shouldn’t try.”
References
1. Braveman P, et al. What is health equity? And what difference does a definition make? Robert Wood Johnson Foundation. Published May 2017. Accessed July 15, 2017.
2. Communities in Action: Pathways to Health Equity. National Academies of Sciences, Engineering and Medicine. Published Jan. 11, 2017. Accessed July 15, 2017.
VIDEO: Laparoscopy is a safe approach throughout pregnancy, expert says
NATIONAL HARBOR, MD. – Laparoscopy offers advantages over laparotomy when performing nonobstetrical surgery on pregnant women, Yuval Kaufman, MD, said at the AAGL Global Congress.
“When we talk about advantages in referral to the pregnant patient, one of the most important things is early ambulation,” Dr. Kaufman, a gynecologic surgeon at Carmel Medical Center in Haifa, Israel, said in an interview. “These patients are in a hypercoagulable state; they are more likely to have DVT and PE. You need them up and running as soon as possible.”
Laparoscopy also tends to be better in terms of handling of the uterus, offering a field of view so that the uterus doesn’t need to be moved as much. In addition, laparoscopy is associated with a smaller, more easily healed scar, and usually requires fewer analgesics, which is better for the fetus, he said.
The Society of American Gastrointestinal and Endoscopic Surgeons recently issued guidelines for the use of laparoscopy during pregnancy, advising surgeons that these procedures can be safely performed during any trimester when the operation is indicated, he said.
“There was an older misconception that surgery has to be done in the second trimester only,” Dr. Kaufman said. “But they actually contradict that; they show that if you postpone surgery for this reason you might be doing much more damage to the mother and to the fetus.”
Dr. Kaufman reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Laparoscopy offers advantages over laparotomy when performing nonobstetrical surgery on pregnant women, Yuval Kaufman, MD, said at the AAGL Global Congress.
“When we talk about advantages in referral to the pregnant patient, one of the most important things is early ambulation,” Dr. Kaufman, a gynecologic surgeon at Carmel Medical Center in Haifa, Israel, said in an interview. “These patients are in a hypercoagulable state; they are more likely to have DVT and PE. You need them up and running as soon as possible.”
Laparoscopy also tends to be better in terms of handling of the uterus, offering a field of view so that the uterus doesn’t need to be moved as much. In addition, laparoscopy is associated with a smaller, more easily healed scar, and usually requires fewer analgesics, which is better for the fetus, he said.
The Society of American Gastrointestinal and Endoscopic Surgeons recently issued guidelines for the use of laparoscopy during pregnancy, advising surgeons that these procedures can be safely performed during any trimester when the operation is indicated, he said.
“There was an older misconception that surgery has to be done in the second trimester only,” Dr. Kaufman said. “But they actually contradict that; they show that if you postpone surgery for this reason you might be doing much more damage to the mother and to the fetus.”
Dr. Kaufman reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Laparoscopy offers advantages over laparotomy when performing nonobstetrical surgery on pregnant women, Yuval Kaufman, MD, said at the AAGL Global Congress.
“When we talk about advantages in referral to the pregnant patient, one of the most important things is early ambulation,” Dr. Kaufman, a gynecologic surgeon at Carmel Medical Center in Haifa, Israel, said in an interview. “These patients are in a hypercoagulable state; they are more likely to have DVT and PE. You need them up and running as soon as possible.”
Laparoscopy also tends to be better in terms of handling of the uterus, offering a field of view so that the uterus doesn’t need to be moved as much. In addition, laparoscopy is associated with a smaller, more easily healed scar, and usually requires fewer analgesics, which is better for the fetus, he said.
The Society of American Gastrointestinal and Endoscopic Surgeons recently issued guidelines for the use of laparoscopy during pregnancy, advising surgeons that these procedures can be safely performed during any trimester when the operation is indicated, he said.
“There was an older misconception that surgery has to be done in the second trimester only,” Dr. Kaufman said. “But they actually contradict that; they show that if you postpone surgery for this reason you might be doing much more damage to the mother and to the fetus.”
Dr. Kaufman reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT AAGL 2017
Development of a sigma 1 receptor agonist for Alzheimer’s proceeds based on 2-year phase 2 data
BOSTON – A reputedly neuroprotective compound will advance along its developmental pathway after developers said it exerted a blood level–dependent relationship with both cognitive and functional measures in patients with mild to moderate Alzheimer’s.
Most of the 26 patients left in the ongoing phase 2a extension study of ANAVEX 2-73 declined cognitively and functionally by varying degrees over 1 year. But a few, most of whom had high drug plasma levels, did experience cognitive and functional changes for the better. Some maintained stability, and some improved on both measures over 109 weeks, according to Christopher U. Missling, PhD, president and chief executive officer of Anavex.
“Improvement of cognition or function was a rare occurrence, but our analysis showed that patients who had a plasma concentration of 4-12 ng/mL had the best chance of experiencing this,” Dr. Missling said in an interview.
Mohammad Afshar, MD, PhD, presented these data at the Clinical Trials in Alzheimer’s Disease conference. He is the head of Ariana Pharmaceuticals, a firm hired to perform an independent analysis of the Anavex data. Concentrating on the pharmacodynamics data, he said ANAVEX 2-73 exhibits a clear drug concentration–clinical response relationship, which supports taking the drug into a phase 2/3 study.
“When focusing on the best responders at week 57, they continued to perform well. Patients with a score of greater than 20 on the Mini-Mental State Exam at baseline tended to respond better, as well as those with the highest plasma concentration,” he said.
The concentration-response picture is not completely clear, however. While five patients with high levels did improve on the MMSE at 57 weeks, one patient with a low plasma level also improved, and four patients with high levels declined. Functional results appeared more clearly related to drug levels: All of the high-level patients except one improved, as did about half of those with moderate plasma levels. Everyone with a low level declined.
During a later interview, Dr. Missling reviewed the data with an eye toward understatement. The study’s primary endpoints are safety and tolerability, as well as dosing and pharmacokinetics, he noted – cognitive and functional endpoints are exploratory measures. The study never had a control arm, other than several historical cohorts that served as reference points for decline in typically managed Alzheimer’s patients. And of course, he said, the numbers are very, very small.
And yet, the results are a source of “cautious optimism,” Dr. Missling said.
“While we think this is remarkable – because no drug has yet shown this long a response in non-decline among Alzheimer’s patients – we want to be very cautious. We are only looking at six patients here. We can’t overinterpret this.”
Dr. Missling and his colleagues are trying to find commonalities in these patients’ characteristics and clinical responses, hoping to enroll a phase 2/3 cohort of similar profile – whatever that may be. “We’re looking at the patients who improved to try and identify characteristics and be sure to enroll people who match them, to try and maximize our chance of success in phase 2/3,” which he said should be announced by the end of this year.
Just as important, he said, is to scrutinize the outliers – patients whose high and low plasma levels didn’t line up with the group’s overall response curve. “We’re looking at them in depth,” Dr. Missling said, adding that every patient in the study will undergo a full genomic profile, along with both an RNA and gut microbiota profile.
ANAVEX 2-73 is a sigma 1 receptor agonist. A chaperone protein, sigma 1 is activated in response to acute and chronic cellular stressors, several of which are important in neurodegeneration. The sigma 1 receptor is found on neurons and glia in many areas of the central nervous system. It modulates numerous processes implicated in neurodegenerative diseases, including glutamate and calcium activity, reaction to oxidative stress, and mitochondrial function. There is some evidence that sigma 1 receptor activation can induce neuronal regrowth and functional recovery after stroke. Sigma 1 also appears to play a role in helping cells clear misfolded proteins – a pathway that makes it an attractive drug target in Alzheimer’s disease, as well as other neurodegenerative diseases with aberrant proteins, such as Parkinson’s and Huntington’s diseases.
“Sigma 1 is never used except in times of trouble,” Dr. Missling said. “It’s only needed if we have a serious dysfunction in cells. By giving an agonist, we are increasing the expression of this protein, so it’s a bit like immune stimulation in oncology. We’re using the body’s own mechanism,” to fight neurodegeneration.
ANAVEX 2-73’s phase 2 development started with a 5-week crossover trial of 32 patients; they were a mean of 71 years old, with a mean MMSE of 21. The initial phase was followed by a 52-week, open-label trial of 10, 20, 30, and 50 mg/day orally, titrating each patient to the maximum tolerated dose.
Dr. Afshar presented 57-week data for the 26 patients who were still in the trial at that point and 109-week data for the six patients who had the best response at 57 weeks. Patients in both analyses were grouped by plasma level, not by their dosage level, although Dr. Missling said higher dosage generally correlated with higher plasma levels.
At 57 weeks, six patients had improved on the MMSE: four with high plasma levels and two with low plasma levels – patients identified as “outliers.” One patient with a high level remained stable. The rest of the cohort declined: seven with low levels, eight with moderate levels, and four with high levels, who were also identified as outliers. Also at 57 weeks, 24 patients had full data on the functional measure, the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). Nine patients had improved: five with high plasma levels, three with moderate levels, and one with a low level, identified as an outlier. One patient, with a moderate level, remained stable. The remaining 14 patients declined: nine with moderate levels, four with low levels, and one with a high level, dubbed an outlier.
Dr. Afshar reported more detailed data on the six best-performing patients. These included the two patients with low plasma levels who were characterized in the 57-week MMSE data as outliers. Their mean baseline MMSE went from 23.2 to 25.7 at 57 weeks; their mean functional score on the ADCS-ADL scale rose from 72 to 73.7.
He then showed each of these patients’ 109-week changes. Each was identified with a unique number in both the 57- and 109-week datasets. Numbers here are estimates drawn from the company’s data slides, which are publicly available on the Anavex website.
The ADCS-ADL is a caregiver-rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 implies full functioning with no impairment. On the 30-point MMSE scale, a score greater of 24 or higher indicates a normal cognition.
• 101009 (low plasma level)
MMSE: 20-29 ADCS-ADL: 73-71
• 101011 (low plasma level)
MMSE: 20-21 ADCS-ADL: 72-70
•101013 (high plasma level)
MMSE: 22-18 ADCS-ADL: 73-57
• 101014 (high plasma level)
MMSE: 20-25 ADCS-ADL: 75-74
• 102006 (high plasma level)
MMSE: 25-28 ADCS-ADL: 74-78
• 102010 (high plasma level)
MMSE: 25-28 ADCS-ADL: 64-68
Dr. Missling said ANAVEX 2-73 still appears safe and well tolerated. In the initial study phase, 98% of the subjects did have an adverse event; only one was considered serious. This was a case of delirium that developed in a patient who had several risk factors for the disorder, including a prior episode, and was not considered related to the study drug. Three patients withdrew because of an adverse event in the first 57 weeks; no one has withdrawn because of a side effect since then.
Dizziness was the most common adverse event (20 incidents in 15 patients), followed by headache (16 in 10 patients). Most (94%) occurred in the first week of treatment. All were mild or moderate. Headache and dizziness are considered signs that patients are approaching their maximum tolerated dose, Dr. Missling said.
The company’s task now is to find a standard minimum dose that is strong enough to get patients to at least 4 ng/mL plasma level, without inducing these side effects. The extension study will close out in November 2018. Anavex hopes to begin the drug’s next phase of development before then, with a phase 2/3 study of about 200 patients.
“We’re trying to gather as much data as possible so we can do this properly,” Dr. Missling said. “You can make the case that some developers have rushed into these studies after interpreting early results the wrong way. They said the glass was half-full when it was really half-empty. For us, it’s very important not to do that. We won’t go ahead with this until we are completely comfortable with what we see.”
msullivan@frontlinemedcom.com
On Twitter @alz_gal
BOSTON – A reputedly neuroprotective compound will advance along its developmental pathway after developers said it exerted a blood level–dependent relationship with both cognitive and functional measures in patients with mild to moderate Alzheimer’s.
Most of the 26 patients left in the ongoing phase 2a extension study of ANAVEX 2-73 declined cognitively and functionally by varying degrees over 1 year. But a few, most of whom had high drug plasma levels, did experience cognitive and functional changes for the better. Some maintained stability, and some improved on both measures over 109 weeks, according to Christopher U. Missling, PhD, president and chief executive officer of Anavex.
“Improvement of cognition or function was a rare occurrence, but our analysis showed that patients who had a plasma concentration of 4-12 ng/mL had the best chance of experiencing this,” Dr. Missling said in an interview.
Mohammad Afshar, MD, PhD, presented these data at the Clinical Trials in Alzheimer’s Disease conference. He is the head of Ariana Pharmaceuticals, a firm hired to perform an independent analysis of the Anavex data. Concentrating on the pharmacodynamics data, he said ANAVEX 2-73 exhibits a clear drug concentration–clinical response relationship, which supports taking the drug into a phase 2/3 study.
“When focusing on the best responders at week 57, they continued to perform well. Patients with a score of greater than 20 on the Mini-Mental State Exam at baseline tended to respond better, as well as those with the highest plasma concentration,” he said.
The concentration-response picture is not completely clear, however. While five patients with high levels did improve on the MMSE at 57 weeks, one patient with a low plasma level also improved, and four patients with high levels declined. Functional results appeared more clearly related to drug levels: All of the high-level patients except one improved, as did about half of those with moderate plasma levels. Everyone with a low level declined.
During a later interview, Dr. Missling reviewed the data with an eye toward understatement. The study’s primary endpoints are safety and tolerability, as well as dosing and pharmacokinetics, he noted – cognitive and functional endpoints are exploratory measures. The study never had a control arm, other than several historical cohorts that served as reference points for decline in typically managed Alzheimer’s patients. And of course, he said, the numbers are very, very small.
And yet, the results are a source of “cautious optimism,” Dr. Missling said.
“While we think this is remarkable – because no drug has yet shown this long a response in non-decline among Alzheimer’s patients – we want to be very cautious. We are only looking at six patients here. We can’t overinterpret this.”
Dr. Missling and his colleagues are trying to find commonalities in these patients’ characteristics and clinical responses, hoping to enroll a phase 2/3 cohort of similar profile – whatever that may be. “We’re looking at the patients who improved to try and identify characteristics and be sure to enroll people who match them, to try and maximize our chance of success in phase 2/3,” which he said should be announced by the end of this year.
Just as important, he said, is to scrutinize the outliers – patients whose high and low plasma levels didn’t line up with the group’s overall response curve. “We’re looking at them in depth,” Dr. Missling said, adding that every patient in the study will undergo a full genomic profile, along with both an RNA and gut microbiota profile.
ANAVEX 2-73 is a sigma 1 receptor agonist. A chaperone protein, sigma 1 is activated in response to acute and chronic cellular stressors, several of which are important in neurodegeneration. The sigma 1 receptor is found on neurons and glia in many areas of the central nervous system. It modulates numerous processes implicated in neurodegenerative diseases, including glutamate and calcium activity, reaction to oxidative stress, and mitochondrial function. There is some evidence that sigma 1 receptor activation can induce neuronal regrowth and functional recovery after stroke. Sigma 1 also appears to play a role in helping cells clear misfolded proteins – a pathway that makes it an attractive drug target in Alzheimer’s disease, as well as other neurodegenerative diseases with aberrant proteins, such as Parkinson’s and Huntington’s diseases.
“Sigma 1 is never used except in times of trouble,” Dr. Missling said. “It’s only needed if we have a serious dysfunction in cells. By giving an agonist, we are increasing the expression of this protein, so it’s a bit like immune stimulation in oncology. We’re using the body’s own mechanism,” to fight neurodegeneration.
ANAVEX 2-73’s phase 2 development started with a 5-week crossover trial of 32 patients; they were a mean of 71 years old, with a mean MMSE of 21. The initial phase was followed by a 52-week, open-label trial of 10, 20, 30, and 50 mg/day orally, titrating each patient to the maximum tolerated dose.
Dr. Afshar presented 57-week data for the 26 patients who were still in the trial at that point and 109-week data for the six patients who had the best response at 57 weeks. Patients in both analyses were grouped by plasma level, not by their dosage level, although Dr. Missling said higher dosage generally correlated with higher plasma levels.
At 57 weeks, six patients had improved on the MMSE: four with high plasma levels and two with low plasma levels – patients identified as “outliers.” One patient with a high level remained stable. The rest of the cohort declined: seven with low levels, eight with moderate levels, and four with high levels, who were also identified as outliers. Also at 57 weeks, 24 patients had full data on the functional measure, the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). Nine patients had improved: five with high plasma levels, three with moderate levels, and one with a low level, identified as an outlier. One patient, with a moderate level, remained stable. The remaining 14 patients declined: nine with moderate levels, four with low levels, and one with a high level, dubbed an outlier.
Dr. Afshar reported more detailed data on the six best-performing patients. These included the two patients with low plasma levels who were characterized in the 57-week MMSE data as outliers. Their mean baseline MMSE went from 23.2 to 25.7 at 57 weeks; their mean functional score on the ADCS-ADL scale rose from 72 to 73.7.
He then showed each of these patients’ 109-week changes. Each was identified with a unique number in both the 57- and 109-week datasets. Numbers here are estimates drawn from the company’s data slides, which are publicly available on the Anavex website.
The ADCS-ADL is a caregiver-rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 implies full functioning with no impairment. On the 30-point MMSE scale, a score greater of 24 or higher indicates a normal cognition.
• 101009 (low plasma level)
MMSE: 20-29 ADCS-ADL: 73-71
• 101011 (low plasma level)
MMSE: 20-21 ADCS-ADL: 72-70
•101013 (high plasma level)
MMSE: 22-18 ADCS-ADL: 73-57
• 101014 (high plasma level)
MMSE: 20-25 ADCS-ADL: 75-74
• 102006 (high plasma level)
MMSE: 25-28 ADCS-ADL: 74-78
• 102010 (high plasma level)
MMSE: 25-28 ADCS-ADL: 64-68
Dr. Missling said ANAVEX 2-73 still appears safe and well tolerated. In the initial study phase, 98% of the subjects did have an adverse event; only one was considered serious. This was a case of delirium that developed in a patient who had several risk factors for the disorder, including a prior episode, and was not considered related to the study drug. Three patients withdrew because of an adverse event in the first 57 weeks; no one has withdrawn because of a side effect since then.
Dizziness was the most common adverse event (20 incidents in 15 patients), followed by headache (16 in 10 patients). Most (94%) occurred in the first week of treatment. All were mild or moderate. Headache and dizziness are considered signs that patients are approaching their maximum tolerated dose, Dr. Missling said.
The company’s task now is to find a standard minimum dose that is strong enough to get patients to at least 4 ng/mL plasma level, without inducing these side effects. The extension study will close out in November 2018. Anavex hopes to begin the drug’s next phase of development before then, with a phase 2/3 study of about 200 patients.
“We’re trying to gather as much data as possible so we can do this properly,” Dr. Missling said. “You can make the case that some developers have rushed into these studies after interpreting early results the wrong way. They said the glass was half-full when it was really half-empty. For us, it’s very important not to do that. We won’t go ahead with this until we are completely comfortable with what we see.”
msullivan@frontlinemedcom.com
On Twitter @alz_gal
BOSTON – A reputedly neuroprotective compound will advance along its developmental pathway after developers said it exerted a blood level–dependent relationship with both cognitive and functional measures in patients with mild to moderate Alzheimer’s.
Most of the 26 patients left in the ongoing phase 2a extension study of ANAVEX 2-73 declined cognitively and functionally by varying degrees over 1 year. But a few, most of whom had high drug plasma levels, did experience cognitive and functional changes for the better. Some maintained stability, and some improved on both measures over 109 weeks, according to Christopher U. Missling, PhD, president and chief executive officer of Anavex.
“Improvement of cognition or function was a rare occurrence, but our analysis showed that patients who had a plasma concentration of 4-12 ng/mL had the best chance of experiencing this,” Dr. Missling said in an interview.
Mohammad Afshar, MD, PhD, presented these data at the Clinical Trials in Alzheimer’s Disease conference. He is the head of Ariana Pharmaceuticals, a firm hired to perform an independent analysis of the Anavex data. Concentrating on the pharmacodynamics data, he said ANAVEX 2-73 exhibits a clear drug concentration–clinical response relationship, which supports taking the drug into a phase 2/3 study.
“When focusing on the best responders at week 57, they continued to perform well. Patients with a score of greater than 20 on the Mini-Mental State Exam at baseline tended to respond better, as well as those with the highest plasma concentration,” he said.
The concentration-response picture is not completely clear, however. While five patients with high levels did improve on the MMSE at 57 weeks, one patient with a low plasma level also improved, and four patients with high levels declined. Functional results appeared more clearly related to drug levels: All of the high-level patients except one improved, as did about half of those with moderate plasma levels. Everyone with a low level declined.
During a later interview, Dr. Missling reviewed the data with an eye toward understatement. The study’s primary endpoints are safety and tolerability, as well as dosing and pharmacokinetics, he noted – cognitive and functional endpoints are exploratory measures. The study never had a control arm, other than several historical cohorts that served as reference points for decline in typically managed Alzheimer’s patients. And of course, he said, the numbers are very, very small.
And yet, the results are a source of “cautious optimism,” Dr. Missling said.
“While we think this is remarkable – because no drug has yet shown this long a response in non-decline among Alzheimer’s patients – we want to be very cautious. We are only looking at six patients here. We can’t overinterpret this.”
Dr. Missling and his colleagues are trying to find commonalities in these patients’ characteristics and clinical responses, hoping to enroll a phase 2/3 cohort of similar profile – whatever that may be. “We’re looking at the patients who improved to try and identify characteristics and be sure to enroll people who match them, to try and maximize our chance of success in phase 2/3,” which he said should be announced by the end of this year.
Just as important, he said, is to scrutinize the outliers – patients whose high and low plasma levels didn’t line up with the group’s overall response curve. “We’re looking at them in depth,” Dr. Missling said, adding that every patient in the study will undergo a full genomic profile, along with both an RNA and gut microbiota profile.
ANAVEX 2-73 is a sigma 1 receptor agonist. A chaperone protein, sigma 1 is activated in response to acute and chronic cellular stressors, several of which are important in neurodegeneration. The sigma 1 receptor is found on neurons and glia in many areas of the central nervous system. It modulates numerous processes implicated in neurodegenerative diseases, including glutamate and calcium activity, reaction to oxidative stress, and mitochondrial function. There is some evidence that sigma 1 receptor activation can induce neuronal regrowth and functional recovery after stroke. Sigma 1 also appears to play a role in helping cells clear misfolded proteins – a pathway that makes it an attractive drug target in Alzheimer’s disease, as well as other neurodegenerative diseases with aberrant proteins, such as Parkinson’s and Huntington’s diseases.
“Sigma 1 is never used except in times of trouble,” Dr. Missling said. “It’s only needed if we have a serious dysfunction in cells. By giving an agonist, we are increasing the expression of this protein, so it’s a bit like immune stimulation in oncology. We’re using the body’s own mechanism,” to fight neurodegeneration.
ANAVEX 2-73’s phase 2 development started with a 5-week crossover trial of 32 patients; they were a mean of 71 years old, with a mean MMSE of 21. The initial phase was followed by a 52-week, open-label trial of 10, 20, 30, and 50 mg/day orally, titrating each patient to the maximum tolerated dose.
Dr. Afshar presented 57-week data for the 26 patients who were still in the trial at that point and 109-week data for the six patients who had the best response at 57 weeks. Patients in both analyses were grouped by plasma level, not by their dosage level, although Dr. Missling said higher dosage generally correlated with higher plasma levels.
At 57 weeks, six patients had improved on the MMSE: four with high plasma levels and two with low plasma levels – patients identified as “outliers.” One patient with a high level remained stable. The rest of the cohort declined: seven with low levels, eight with moderate levels, and four with high levels, who were also identified as outliers. Also at 57 weeks, 24 patients had full data on the functional measure, the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). Nine patients had improved: five with high plasma levels, three with moderate levels, and one with a low level, identified as an outlier. One patient, with a moderate level, remained stable. The remaining 14 patients declined: nine with moderate levels, four with low levels, and one with a high level, dubbed an outlier.
Dr. Afshar reported more detailed data on the six best-performing patients. These included the two patients with low plasma levels who were characterized in the 57-week MMSE data as outliers. Their mean baseline MMSE went from 23.2 to 25.7 at 57 weeks; their mean functional score on the ADCS-ADL scale rose from 72 to 73.7.
He then showed each of these patients’ 109-week changes. Each was identified with a unique number in both the 57- and 109-week datasets. Numbers here are estimates drawn from the company’s data slides, which are publicly available on the Anavex website.
The ADCS-ADL is a caregiver-rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 implies full functioning with no impairment. On the 30-point MMSE scale, a score greater of 24 or higher indicates a normal cognition.
• 101009 (low plasma level)
MMSE: 20-29 ADCS-ADL: 73-71
• 101011 (low plasma level)
MMSE: 20-21 ADCS-ADL: 72-70
•101013 (high plasma level)
MMSE: 22-18 ADCS-ADL: 73-57
• 101014 (high plasma level)
MMSE: 20-25 ADCS-ADL: 75-74
• 102006 (high plasma level)
MMSE: 25-28 ADCS-ADL: 74-78
• 102010 (high plasma level)
MMSE: 25-28 ADCS-ADL: 64-68
Dr. Missling said ANAVEX 2-73 still appears safe and well tolerated. In the initial study phase, 98% of the subjects did have an adverse event; only one was considered serious. This was a case of delirium that developed in a patient who had several risk factors for the disorder, including a prior episode, and was not considered related to the study drug. Three patients withdrew because of an adverse event in the first 57 weeks; no one has withdrawn because of a side effect since then.
Dizziness was the most common adverse event (20 incidents in 15 patients), followed by headache (16 in 10 patients). Most (94%) occurred in the first week of treatment. All were mild or moderate. Headache and dizziness are considered signs that patients are approaching their maximum tolerated dose, Dr. Missling said.
The company’s task now is to find a standard minimum dose that is strong enough to get patients to at least 4 ng/mL plasma level, without inducing these side effects. The extension study will close out in November 2018. Anavex hopes to begin the drug’s next phase of development before then, with a phase 2/3 study of about 200 patients.
“We’re trying to gather as much data as possible so we can do this properly,” Dr. Missling said. “You can make the case that some developers have rushed into these studies after interpreting early results the wrong way. They said the glass was half-full when it was really half-empty. For us, it’s very important not to do that. We won’t go ahead with this until we are completely comfortable with what we see.”
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT CTAD
Key clinical point:
Major finding: Among the six best responders, the mean baseline MMSE went from 23.2 to 25.7; the mean functional score on the Alzheimer’s Disease Cooperative Study-activities of daily living scale rose from 72 to 73.7.
Data source: The phase 2a study is following 26 patients.
Disclosures: Dr. Christopher Missling is the chief executive officer of Anavex, which is developing 2-73. Dr. Mohammed Afshar is the CEO of Ariana Pharmaceuticals, which was hired to perform an independent data analysis of the study.
The Liver Meeting 2017 NAFLD debrief – key abstracts
WASHINGTON – Nonalcoholic fatty liver disease (NAFLD) is a complex disease that involves multiple systems, and several standout abstracts at the annual meeting of the American Association for the Study of Liver Diseases emphasized the importance of multisystem management and the potential of combination therapies, Kymberly D. Watt, MD, said during the final debrief.
“The actual underlying mechanisms and the underlying processes that are going on are way more complicated than just inflammation and scarring,” said Dr. Watt, associate professor of medicine and medical director of liver transplantation at the Mayo Clinic, Rochester, Minn. “We have numerous areas to target, including insulin resistance, lipid metabolism, oxidative stress, inflammation, immune modulation, cell death, etc.”
She noted several studies that evaluated the prevalence of NAFLD, including a study that found that “about one-third of patients walking through the door of the clinic had nonalcoholic steatohepatitis [NASH],” suggesting physicians should consider screening at-risk patients (abstract 58). A Korean study found about 18% of asymptomatic lean individuals (body mass index less than 23 kg/m2) had NAFLD and identified sarcopenia as a significant risk factor for NAFLD in these lean patients (abstract 59). “Sarcopenia is something that we really need to pay a lot more attention to,” Dr. Watt said.
Other studies better outlined the increasing association between NAFLD and hepatocellular carcinoma, Dr. Watt noted (abstracts 2119 and 2102). Another study confirmed that men with NAFLD/NASH have almost twice the incidence of hepatocellular carcinoma (HCC) as women — 0.43%-0.5% vs. 0.22%-0.28%, with both groups significantly higher than the general population (abstract 2116). “And looking further, we can actually quote an HCC incidence in NASH of 0.009%,” she added.
Again emphasizing the multisystem impact of NAFLD, Dr. Watt cited a study that calculated the cardiovascular risks incumbent with liver disease. Researchers reported that men and women at the time of NAFLD diagnosis had significantly higher rates of either angina/ischemic heart disease or heart failure (abstract 55). Women, specifically, had a higher risk for cardiovascular events earlier than men and overall are at equal risk to men, unlike in the general population where women are at lower risk. “We need to start looking at screening and prevention of other diseases in our patients with NASH,” Dr. Watt said. “In addition, we need to be more aware of the elevated risk in these patients and not just approach them in the same way as the general population.”
Physicians may be tempted to discontinue statin therapy in patients with chronic liver disease, but Dr. Watt cited a poster that showed that this results in worse outcomes (abstract 2106). The researchers found that continued statin use was associated with a lower risk of death with compensated and decompensated liver function. “These data help to educate certain patients of their risk of decompensation over time,” Dr. Watt said.
An international study determined that the severity of advanced compensated liver disease is a key determinant in outcomes, finding that those with bridging fibrosis are at greater risk of vascular events, but those with cirrhosis and Child-Turcotte-Pugh A5 and A6 disease have much higher risks of hepatic decompensation and HCC out to 14 years (abstract 60). “The reason to look at these is to be able to tell your patients that they probably have a 30% increased risk of decompensation by 4 years,” Dr. Watt said.
Dr. Watt pointed out three studies that shed more light on important biomarkers of NAFLD. One study reported that three biomarkers – alpha-2-macroglobulin, hyaluronic acid, and tissue inhibitor of metalloproteinase-1 – have a high sensitivity for differentiating low-stage and stage F3-F4 disease (abstract 95). Another study found that a measure using Pro-C3 and other clinical markers were predictive of F3 or F4 fibrosis in NAFLD (abstract 93). And, other researchers found that a HepQuant-STAT measure of greater than 0.50 microM in patients who ingested deuterated cholic acid (d4-CA) solution may be a minimally invasive alternative to biopsy for diagnosing NASH (abstract 96).
Management studies focusing on varying targets were also presented. A trial of fibroblast growth factor–21 for treatment of NAFLD found that patients in the 10- and 20-mg dose arms showed improvement in MRI hepatic fat fraction, ALT, AST, and liver stiffness at 16 weeks vs. placebo. A few patients had some mild elevation to their liver enzymes on treatment (abstract 182). “So I think we need to remain cautious and watch these patients closely, but overall it seems to be reasonably safe data,” she said. Another drug trial of the acetyl-CoA carboxylase inhibitor GS-0976 also showed promise for overall improvement in MRI steatosis measures (abstract LB-9).
Three preclinical studies of dual-agent therapies in animals have demonstrated improvement in inflammatory and fibrosis scores, Dr. Watt noted (abstracts 2,000, 2,002 and 2,052). “There’s no one drug that’s going to be likely the magic cure,” Dr. Watt said. “There will likely be a lot more focus and data coming out on dual-action agents.” Another animal study addressed the burning question if decaffeinated coffee has the same protective effect against NASH as caffeinated coffee (abstract 2093). Said Dr. Watt: “If you are interested in the potential benefits of coffee but really can’t handle the caffeine, this study suggests, you may still be OK.”
Finally, Dr. Watt noted an early study of three-dimensional printing has shown potential for replicating NASH tissue for bench studies (abstract 1963). “3-D printing is certainly a wave of the future,” she said, pointing out that researchers have created a 3-D model that has some metabolic equivalency to NASH, with the inflammatory cytokine release, hepatic stellate cell activation, “and all of the features that we see in NASH. This may be of potential use down the road to avoid relying on animal models in preclinical studies.”
The Liver Meeting next convenes Nov. 9-13, 2018, in San Francisco.
Dr. Watt disclosed ties to Bristol-Myers Squibb, Exelixis, and Seattle Genetics.
WASHINGTON – Nonalcoholic fatty liver disease (NAFLD) is a complex disease that involves multiple systems, and several standout abstracts at the annual meeting of the American Association for the Study of Liver Diseases emphasized the importance of multisystem management and the potential of combination therapies, Kymberly D. Watt, MD, said during the final debrief.
“The actual underlying mechanisms and the underlying processes that are going on are way more complicated than just inflammation and scarring,” said Dr. Watt, associate professor of medicine and medical director of liver transplantation at the Mayo Clinic, Rochester, Minn. “We have numerous areas to target, including insulin resistance, lipid metabolism, oxidative stress, inflammation, immune modulation, cell death, etc.”
She noted several studies that evaluated the prevalence of NAFLD, including a study that found that “about one-third of patients walking through the door of the clinic had nonalcoholic steatohepatitis [NASH],” suggesting physicians should consider screening at-risk patients (abstract 58). A Korean study found about 18% of asymptomatic lean individuals (body mass index less than 23 kg/m2) had NAFLD and identified sarcopenia as a significant risk factor for NAFLD in these lean patients (abstract 59). “Sarcopenia is something that we really need to pay a lot more attention to,” Dr. Watt said.
Other studies better outlined the increasing association between NAFLD and hepatocellular carcinoma, Dr. Watt noted (abstracts 2119 and 2102). Another study confirmed that men with NAFLD/NASH have almost twice the incidence of hepatocellular carcinoma (HCC) as women — 0.43%-0.5% vs. 0.22%-0.28%, with both groups significantly higher than the general population (abstract 2116). “And looking further, we can actually quote an HCC incidence in NASH of 0.009%,” she added.
Again emphasizing the multisystem impact of NAFLD, Dr. Watt cited a study that calculated the cardiovascular risks incumbent with liver disease. Researchers reported that men and women at the time of NAFLD diagnosis had significantly higher rates of either angina/ischemic heart disease or heart failure (abstract 55). Women, specifically, had a higher risk for cardiovascular events earlier than men and overall are at equal risk to men, unlike in the general population where women are at lower risk. “We need to start looking at screening and prevention of other diseases in our patients with NASH,” Dr. Watt said. “In addition, we need to be more aware of the elevated risk in these patients and not just approach them in the same way as the general population.”
Physicians may be tempted to discontinue statin therapy in patients with chronic liver disease, but Dr. Watt cited a poster that showed that this results in worse outcomes (abstract 2106). The researchers found that continued statin use was associated with a lower risk of death with compensated and decompensated liver function. “These data help to educate certain patients of their risk of decompensation over time,” Dr. Watt said.
An international study determined that the severity of advanced compensated liver disease is a key determinant in outcomes, finding that those with bridging fibrosis are at greater risk of vascular events, but those with cirrhosis and Child-Turcotte-Pugh A5 and A6 disease have much higher risks of hepatic decompensation and HCC out to 14 years (abstract 60). “The reason to look at these is to be able to tell your patients that they probably have a 30% increased risk of decompensation by 4 years,” Dr. Watt said.
Dr. Watt pointed out three studies that shed more light on important biomarkers of NAFLD. One study reported that three biomarkers – alpha-2-macroglobulin, hyaluronic acid, and tissue inhibitor of metalloproteinase-1 – have a high sensitivity for differentiating low-stage and stage F3-F4 disease (abstract 95). Another study found that a measure using Pro-C3 and other clinical markers were predictive of F3 or F4 fibrosis in NAFLD (abstract 93). And, other researchers found that a HepQuant-STAT measure of greater than 0.50 microM in patients who ingested deuterated cholic acid (d4-CA) solution may be a minimally invasive alternative to biopsy for diagnosing NASH (abstract 96).
Management studies focusing on varying targets were also presented. A trial of fibroblast growth factor–21 for treatment of NAFLD found that patients in the 10- and 20-mg dose arms showed improvement in MRI hepatic fat fraction, ALT, AST, and liver stiffness at 16 weeks vs. placebo. A few patients had some mild elevation to their liver enzymes on treatment (abstract 182). “So I think we need to remain cautious and watch these patients closely, but overall it seems to be reasonably safe data,” she said. Another drug trial of the acetyl-CoA carboxylase inhibitor GS-0976 also showed promise for overall improvement in MRI steatosis measures (abstract LB-9).
Three preclinical studies of dual-agent therapies in animals have demonstrated improvement in inflammatory and fibrosis scores, Dr. Watt noted (abstracts 2,000, 2,002 and 2,052). “There’s no one drug that’s going to be likely the magic cure,” Dr. Watt said. “There will likely be a lot more focus and data coming out on dual-action agents.” Another animal study addressed the burning question if decaffeinated coffee has the same protective effect against NASH as caffeinated coffee (abstract 2093). Said Dr. Watt: “If you are interested in the potential benefits of coffee but really can’t handle the caffeine, this study suggests, you may still be OK.”
Finally, Dr. Watt noted an early study of three-dimensional printing has shown potential for replicating NASH tissue for bench studies (abstract 1963). “3-D printing is certainly a wave of the future,” she said, pointing out that researchers have created a 3-D model that has some metabolic equivalency to NASH, with the inflammatory cytokine release, hepatic stellate cell activation, “and all of the features that we see in NASH. This may be of potential use down the road to avoid relying on animal models in preclinical studies.”
The Liver Meeting next convenes Nov. 9-13, 2018, in San Francisco.
Dr. Watt disclosed ties to Bristol-Myers Squibb, Exelixis, and Seattle Genetics.
WASHINGTON – Nonalcoholic fatty liver disease (NAFLD) is a complex disease that involves multiple systems, and several standout abstracts at the annual meeting of the American Association for the Study of Liver Diseases emphasized the importance of multisystem management and the potential of combination therapies, Kymberly D. Watt, MD, said during the final debrief.
“The actual underlying mechanisms and the underlying processes that are going on are way more complicated than just inflammation and scarring,” said Dr. Watt, associate professor of medicine and medical director of liver transplantation at the Mayo Clinic, Rochester, Minn. “We have numerous areas to target, including insulin resistance, lipid metabolism, oxidative stress, inflammation, immune modulation, cell death, etc.”
She noted several studies that evaluated the prevalence of NAFLD, including a study that found that “about one-third of patients walking through the door of the clinic had nonalcoholic steatohepatitis [NASH],” suggesting physicians should consider screening at-risk patients (abstract 58). A Korean study found about 18% of asymptomatic lean individuals (body mass index less than 23 kg/m2) had NAFLD and identified sarcopenia as a significant risk factor for NAFLD in these lean patients (abstract 59). “Sarcopenia is something that we really need to pay a lot more attention to,” Dr. Watt said.
Other studies better outlined the increasing association between NAFLD and hepatocellular carcinoma, Dr. Watt noted (abstracts 2119 and 2102). Another study confirmed that men with NAFLD/NASH have almost twice the incidence of hepatocellular carcinoma (HCC) as women — 0.43%-0.5% vs. 0.22%-0.28%, with both groups significantly higher than the general population (abstract 2116). “And looking further, we can actually quote an HCC incidence in NASH of 0.009%,” she added.
Again emphasizing the multisystem impact of NAFLD, Dr. Watt cited a study that calculated the cardiovascular risks incumbent with liver disease. Researchers reported that men and women at the time of NAFLD diagnosis had significantly higher rates of either angina/ischemic heart disease or heart failure (abstract 55). Women, specifically, had a higher risk for cardiovascular events earlier than men and overall are at equal risk to men, unlike in the general population where women are at lower risk. “We need to start looking at screening and prevention of other diseases in our patients with NASH,” Dr. Watt said. “In addition, we need to be more aware of the elevated risk in these patients and not just approach them in the same way as the general population.”
Physicians may be tempted to discontinue statin therapy in patients with chronic liver disease, but Dr. Watt cited a poster that showed that this results in worse outcomes (abstract 2106). The researchers found that continued statin use was associated with a lower risk of death with compensated and decompensated liver function. “These data help to educate certain patients of their risk of decompensation over time,” Dr. Watt said.
An international study determined that the severity of advanced compensated liver disease is a key determinant in outcomes, finding that those with bridging fibrosis are at greater risk of vascular events, but those with cirrhosis and Child-Turcotte-Pugh A5 and A6 disease have much higher risks of hepatic decompensation and HCC out to 14 years (abstract 60). “The reason to look at these is to be able to tell your patients that they probably have a 30% increased risk of decompensation by 4 years,” Dr. Watt said.
Dr. Watt pointed out three studies that shed more light on important biomarkers of NAFLD. One study reported that three biomarkers – alpha-2-macroglobulin, hyaluronic acid, and tissue inhibitor of metalloproteinase-1 – have a high sensitivity for differentiating low-stage and stage F3-F4 disease (abstract 95). Another study found that a measure using Pro-C3 and other clinical markers were predictive of F3 or F4 fibrosis in NAFLD (abstract 93). And, other researchers found that a HepQuant-STAT measure of greater than 0.50 microM in patients who ingested deuterated cholic acid (d4-CA) solution may be a minimally invasive alternative to biopsy for diagnosing NASH (abstract 96).
Management studies focusing on varying targets were also presented. A trial of fibroblast growth factor–21 for treatment of NAFLD found that patients in the 10- and 20-mg dose arms showed improvement in MRI hepatic fat fraction, ALT, AST, and liver stiffness at 16 weeks vs. placebo. A few patients had some mild elevation to their liver enzymes on treatment (abstract 182). “So I think we need to remain cautious and watch these patients closely, but overall it seems to be reasonably safe data,” she said. Another drug trial of the acetyl-CoA carboxylase inhibitor GS-0976 also showed promise for overall improvement in MRI steatosis measures (abstract LB-9).
Three preclinical studies of dual-agent therapies in animals have demonstrated improvement in inflammatory and fibrosis scores, Dr. Watt noted (abstracts 2,000, 2,002 and 2,052). “There’s no one drug that’s going to be likely the magic cure,” Dr. Watt said. “There will likely be a lot more focus and data coming out on dual-action agents.” Another animal study addressed the burning question if decaffeinated coffee has the same protective effect against NASH as caffeinated coffee (abstract 2093). Said Dr. Watt: “If you are interested in the potential benefits of coffee but really can’t handle the caffeine, this study suggests, you may still be OK.”
Finally, Dr. Watt noted an early study of three-dimensional printing has shown potential for replicating NASH tissue for bench studies (abstract 1963). “3-D printing is certainly a wave of the future,” she said, pointing out that researchers have created a 3-D model that has some metabolic equivalency to NASH, with the inflammatory cytokine release, hepatic stellate cell activation, “and all of the features that we see in NASH. This may be of potential use down the road to avoid relying on animal models in preclinical studies.”
The Liver Meeting next convenes Nov. 9-13, 2018, in San Francisco.
Dr. Watt disclosed ties to Bristol-Myers Squibb, Exelixis, and Seattle Genetics.
AT THE LIVER MEETING 2017
Key clinical point: Nonalcoholic fatty liver disease involves treatment and management of multiple systems.
Major finding: Physicians managing NAFLD must target insulin resistance, lipid metabolism, oxidative stress, and more.
Data source: Debrief of key abstracts on NAFLD presented at the Liver Meeting 2017.
Disclosures: Dr. Watt reported having relationships with Bristol-Myers Squibb, Exelixis, and Seattle Genetics.
Integrating behavioral health and primary care
This is the fourth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Many patients with anxiety, depression, behavioral problems, substance abuse, and other mental and behavioral health conditions turn to their primary care providers as their first, and often only, source of mental health care. Unfortunately, this care may not be as effective as patients and primary care personnel would hope or expect it to be. Problems exist with missed or inaccurate diagnoses, referrals and coordination of care, and other failures in detection and treatment (NIMH Integrated Care Web site, accessed Oct. 1, 2017).
Through the Academy’s web portal interested clinicians, health care administrators, quality improvement specialists, and others can access a wide range of resources related to behavioral health integration. A hallmark of the site is the Integration Playbook, developed as a guide to integrating behavioral health in primary care and other ambulatory care settings. The Playbook assists the growing number of primary care practices and health systems that are beginning to design and implement integrated behavioral health services. The Playbook’s implementation framework is designed to be meaningful at any level of integration development.
One challenge in implementing primary care and behavioral health integration is connecting the community engaged in integrated health care. Often behavioral health and primary care providers operate within the same building or organization but are not be aware of each other’s presence. One goal of the Academy is to unite these disparate efforts and direct providers towards one another in an attempt to facilitate collaboration. In the same vein, the Academy aims to offer resources to patients and the community on integration, including the identification of integrated practices they can access.
In addition, in order to measure quality of care in this new approach to health care delivery, the Academy created the Atlas of Integrated Behavioral Health Care Quality Measures. Intended for practices and teams that wish to understand whether they are providing high-quality integrated behavioral health care or are preparing to implement integrated care, the Atlas aims to support the field of integrated behavioral health care measurement by 1) presenting a framework for understanding measurement of integrated care; 2) providing a list of existing measures relevant to integrated behavioral health care; and 3) organizing the measures by the framework and by user goals to facilitate selection of measures.
Links from the NCEPCR site:
Tools and Resources for Research, Quality Improvement, and Practice
https://www.ahrq.gov/ncepcr/research-qi-practice/practice-transformation-qi.html
Academy Web Portal: https://www.integrationacademy.ahrq.gov
The Integration Playbook: https://integrationacademy.ahrq.gov/playbook/about-playbook
Lexicon: https://integrationacademy.ahrq.gov/lexicon
Atlas of Integrated Behavioral Health Care Quality Measures: https://integrationacademy.ahrq.gov/resources/ibhc-measures-atlas
These and other tools can be found at the NCEPCR Web site: https://www.ahrq.gov/ncepcr.
Dr. Genevro is a health scientist at AHRQ. Dr. Ganiats is director, National Center for Excellence in Primary Care Research, AHRQ.
This is the fourth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Many patients with anxiety, depression, behavioral problems, substance abuse, and other mental and behavioral health conditions turn to their primary care providers as their first, and often only, source of mental health care. Unfortunately, this care may not be as effective as patients and primary care personnel would hope or expect it to be. Problems exist with missed or inaccurate diagnoses, referrals and coordination of care, and other failures in detection and treatment (NIMH Integrated Care Web site, accessed Oct. 1, 2017).
Through the Academy’s web portal interested clinicians, health care administrators, quality improvement specialists, and others can access a wide range of resources related to behavioral health integration. A hallmark of the site is the Integration Playbook, developed as a guide to integrating behavioral health in primary care and other ambulatory care settings. The Playbook assists the growing number of primary care practices and health systems that are beginning to design and implement integrated behavioral health services. The Playbook’s implementation framework is designed to be meaningful at any level of integration development.
One challenge in implementing primary care and behavioral health integration is connecting the community engaged in integrated health care. Often behavioral health and primary care providers operate within the same building or organization but are not be aware of each other’s presence. One goal of the Academy is to unite these disparate efforts and direct providers towards one another in an attempt to facilitate collaboration. In the same vein, the Academy aims to offer resources to patients and the community on integration, including the identification of integrated practices they can access.
In addition, in order to measure quality of care in this new approach to health care delivery, the Academy created the Atlas of Integrated Behavioral Health Care Quality Measures. Intended for practices and teams that wish to understand whether they are providing high-quality integrated behavioral health care or are preparing to implement integrated care, the Atlas aims to support the field of integrated behavioral health care measurement by 1) presenting a framework for understanding measurement of integrated care; 2) providing a list of existing measures relevant to integrated behavioral health care; and 3) organizing the measures by the framework and by user goals to facilitate selection of measures.
Links from the NCEPCR site:
Tools and Resources for Research, Quality Improvement, and Practice
https://www.ahrq.gov/ncepcr/research-qi-practice/practice-transformation-qi.html
Academy Web Portal: https://www.integrationacademy.ahrq.gov
The Integration Playbook: https://integrationacademy.ahrq.gov/playbook/about-playbook
Lexicon: https://integrationacademy.ahrq.gov/lexicon
Atlas of Integrated Behavioral Health Care Quality Measures: https://integrationacademy.ahrq.gov/resources/ibhc-measures-atlas
These and other tools can be found at the NCEPCR Web site: https://www.ahrq.gov/ncepcr.
Dr. Genevro is a health scientist at AHRQ. Dr. Ganiats is director, National Center for Excellence in Primary Care Research, AHRQ.
This is the fourth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Many patients with anxiety, depression, behavioral problems, substance abuse, and other mental and behavioral health conditions turn to their primary care providers as their first, and often only, source of mental health care. Unfortunately, this care may not be as effective as patients and primary care personnel would hope or expect it to be. Problems exist with missed or inaccurate diagnoses, referrals and coordination of care, and other failures in detection and treatment (NIMH Integrated Care Web site, accessed Oct. 1, 2017).
Through the Academy’s web portal interested clinicians, health care administrators, quality improvement specialists, and others can access a wide range of resources related to behavioral health integration. A hallmark of the site is the Integration Playbook, developed as a guide to integrating behavioral health in primary care and other ambulatory care settings. The Playbook assists the growing number of primary care practices and health systems that are beginning to design and implement integrated behavioral health services. The Playbook’s implementation framework is designed to be meaningful at any level of integration development.
One challenge in implementing primary care and behavioral health integration is connecting the community engaged in integrated health care. Often behavioral health and primary care providers operate within the same building or organization but are not be aware of each other’s presence. One goal of the Academy is to unite these disparate efforts and direct providers towards one another in an attempt to facilitate collaboration. In the same vein, the Academy aims to offer resources to patients and the community on integration, including the identification of integrated practices they can access.
In addition, in order to measure quality of care in this new approach to health care delivery, the Academy created the Atlas of Integrated Behavioral Health Care Quality Measures. Intended for practices and teams that wish to understand whether they are providing high-quality integrated behavioral health care or are preparing to implement integrated care, the Atlas aims to support the field of integrated behavioral health care measurement by 1) presenting a framework for understanding measurement of integrated care; 2) providing a list of existing measures relevant to integrated behavioral health care; and 3) organizing the measures by the framework and by user goals to facilitate selection of measures.
Links from the NCEPCR site:
Tools and Resources for Research, Quality Improvement, and Practice
https://www.ahrq.gov/ncepcr/research-qi-practice/practice-transformation-qi.html
Academy Web Portal: https://www.integrationacademy.ahrq.gov
The Integration Playbook: https://integrationacademy.ahrq.gov/playbook/about-playbook
Lexicon: https://integrationacademy.ahrq.gov/lexicon
Atlas of Integrated Behavioral Health Care Quality Measures: https://integrationacademy.ahrq.gov/resources/ibhc-measures-atlas
These and other tools can be found at the NCEPCR Web site: https://www.ahrq.gov/ncepcr.
Dr. Genevro is a health scientist at AHRQ. Dr. Ganiats is director, National Center for Excellence in Primary Care Research, AHRQ.
Journal of Hospital Medicine – Nov. 2017
BACKGROUND AND OBJECTIVES: Adherence to American Academy of Pediatrics (AAP) bronchiolitis clinical practice guideline recommendations improved significantly through the AAP’s multi-institutional collaborative the Bronchiolitis Quality Improvement Project (BQIP). We assessed sustainability of improvements at participating institutions for 1 year following completion of the collaborative.
METHODS: Twenty-one multidisciplinary hospital-based teams provided monthly data for key inpatient bronchiolitis measures during baseline and intervention bronchiolitis seasons. Nine sites provided data in the season following completion of the collaborative. Encounters included children younger than 24 months who were hospitalized for bronchiolitis without comorbid chronic illness, prematurity, or intensive care. Changes between baseline-, intervention-, and sustainability-season data were assessed using generalized linear mixed-effects models with site-specific random effects. Differences between hospital characteristics, baseline performance, and initial improvement among sites that did and did not participate in the sustainability season were compared.
RESULTS: A total of 2,275 discharges were reviewed, comprising 995 baseline, 877 intervention, and 403 sustainability-season encounters. Improvements in all key bronchiolitis quality measures achieved during the intervention season were maintained during the sustainability season, and orders for intermittent pulse oximetry increased from 40.6% (95% confidence interval, 22.8-61.1) to 79.2% (95% CI, 58.0-91.3). Sites that did and did not participate in the sustainability season had similar characteristics.
DISCUSSION: BQIP participating sites maintained improvements in key bronchiolitis quality measures for 1 year following the project’s completion. This approach, which provided an evidence-based best-practice toolkit while building the quality-improvement capacity of local interdisciplinary teams, may support performance gains that persist beyond the active phase of the collaborative.
Also in JHM this month
The effect of an inpatient smoking cessation treatment program on hospital readmissions and length of stayAUTHORS: Eline M. van den Broek-Altenburg, MS, MA, Adam J. Atherly, PhD
Treatment trends and outcomes in healthcare-associated pneumoniaAUTHORS: Sarah Haessler, MD; Tara Lagu, MD, MPH; Peter K. Lindenauer, MD, MSc; Daniel J. Skiest, MD; Aruna Priya, MA, MSc; Penelope S. Pekow, PhD; Marya D. Zilberberg, MD, MPH; Thomas L. Higgins, MD, MBA; Michael B. Rothberg, MD, MPH
What’s the purpose of rounds? A qualitative study examining the perceptions of faculty and studentsAUTHORS: Oliver Hulland; Jeanne Farnan, MD, MHPE; Raphael Rabinowitz; Lisa Kearns, MD, MS; Michele Long, MD; Bradley Monash, MD; Priti Bhansali, MD; H. Barrett Fromme, MD, MHPE
Association between anemia and fatigue in hospitalized patients: does the measure of anemia matter?AUTHORS: Micah T. Prochaska, MD, MS; Richard Newcomb, BA; Graham Block, BA; Brian Park, BA; David O. Meltzer MD, PhD
Helping seniors plan for posthospital discharge needs before a hospitalization occurs: Results from the randomized control trial of planyourlifespan.orgAUTHORS: Lee A. Lindquist, MD, MPH, MBA; Vanessa Ramirez-Zohfeld, MPH; Priya D. Sunkara, MA; Chris Forcucci, RN, BSN; Dianne S. Campbell, BS; Phyllis Mitzen, MA; Jody D. Ciolino, PhD; Gayle Kricke, MSW; Anne Seltzer, LSW; Ana V. Ramirez, BA; Kenzie A. Cameron, PhD, MPH
BACKGROUND AND OBJECTIVES: Adherence to American Academy of Pediatrics (AAP) bronchiolitis clinical practice guideline recommendations improved significantly through the AAP’s multi-institutional collaborative the Bronchiolitis Quality Improvement Project (BQIP). We assessed sustainability of improvements at participating institutions for 1 year following completion of the collaborative.
METHODS: Twenty-one multidisciplinary hospital-based teams provided monthly data for key inpatient bronchiolitis measures during baseline and intervention bronchiolitis seasons. Nine sites provided data in the season following completion of the collaborative. Encounters included children younger than 24 months who were hospitalized for bronchiolitis without comorbid chronic illness, prematurity, or intensive care. Changes between baseline-, intervention-, and sustainability-season data were assessed using generalized linear mixed-effects models with site-specific random effects. Differences between hospital characteristics, baseline performance, and initial improvement among sites that did and did not participate in the sustainability season were compared.
RESULTS: A total of 2,275 discharges were reviewed, comprising 995 baseline, 877 intervention, and 403 sustainability-season encounters. Improvements in all key bronchiolitis quality measures achieved during the intervention season were maintained during the sustainability season, and orders for intermittent pulse oximetry increased from 40.6% (95% confidence interval, 22.8-61.1) to 79.2% (95% CI, 58.0-91.3). Sites that did and did not participate in the sustainability season had similar characteristics.
DISCUSSION: BQIP participating sites maintained improvements in key bronchiolitis quality measures for 1 year following the project’s completion. This approach, which provided an evidence-based best-practice toolkit while building the quality-improvement capacity of local interdisciplinary teams, may support performance gains that persist beyond the active phase of the collaborative.
Also in JHM this month
The effect of an inpatient smoking cessation treatment program on hospital readmissions and length of stayAUTHORS: Eline M. van den Broek-Altenburg, MS, MA, Adam J. Atherly, PhD
Treatment trends and outcomes in healthcare-associated pneumoniaAUTHORS: Sarah Haessler, MD; Tara Lagu, MD, MPH; Peter K. Lindenauer, MD, MSc; Daniel J. Skiest, MD; Aruna Priya, MA, MSc; Penelope S. Pekow, PhD; Marya D. Zilberberg, MD, MPH; Thomas L. Higgins, MD, MBA; Michael B. Rothberg, MD, MPH
What’s the purpose of rounds? A qualitative study examining the perceptions of faculty and studentsAUTHORS: Oliver Hulland; Jeanne Farnan, MD, MHPE; Raphael Rabinowitz; Lisa Kearns, MD, MS; Michele Long, MD; Bradley Monash, MD; Priti Bhansali, MD; H. Barrett Fromme, MD, MHPE
Association between anemia and fatigue in hospitalized patients: does the measure of anemia matter?AUTHORS: Micah T. Prochaska, MD, MS; Richard Newcomb, BA; Graham Block, BA; Brian Park, BA; David O. Meltzer MD, PhD
Helping seniors plan for posthospital discharge needs before a hospitalization occurs: Results from the randomized control trial of planyourlifespan.orgAUTHORS: Lee A. Lindquist, MD, MPH, MBA; Vanessa Ramirez-Zohfeld, MPH; Priya D. Sunkara, MA; Chris Forcucci, RN, BSN; Dianne S. Campbell, BS; Phyllis Mitzen, MA; Jody D. Ciolino, PhD; Gayle Kricke, MSW; Anne Seltzer, LSW; Ana V. Ramirez, BA; Kenzie A. Cameron, PhD, MPH
BACKGROUND AND OBJECTIVES: Adherence to American Academy of Pediatrics (AAP) bronchiolitis clinical practice guideline recommendations improved significantly through the AAP’s multi-institutional collaborative the Bronchiolitis Quality Improvement Project (BQIP). We assessed sustainability of improvements at participating institutions for 1 year following completion of the collaborative.
METHODS: Twenty-one multidisciplinary hospital-based teams provided monthly data for key inpatient bronchiolitis measures during baseline and intervention bronchiolitis seasons. Nine sites provided data in the season following completion of the collaborative. Encounters included children younger than 24 months who were hospitalized for bronchiolitis without comorbid chronic illness, prematurity, or intensive care. Changes between baseline-, intervention-, and sustainability-season data were assessed using generalized linear mixed-effects models with site-specific random effects. Differences between hospital characteristics, baseline performance, and initial improvement among sites that did and did not participate in the sustainability season were compared.
RESULTS: A total of 2,275 discharges were reviewed, comprising 995 baseline, 877 intervention, and 403 sustainability-season encounters. Improvements in all key bronchiolitis quality measures achieved during the intervention season were maintained during the sustainability season, and orders for intermittent pulse oximetry increased from 40.6% (95% confidence interval, 22.8-61.1) to 79.2% (95% CI, 58.0-91.3). Sites that did and did not participate in the sustainability season had similar characteristics.
DISCUSSION: BQIP participating sites maintained improvements in key bronchiolitis quality measures for 1 year following the project’s completion. This approach, which provided an evidence-based best-practice toolkit while building the quality-improvement capacity of local interdisciplinary teams, may support performance gains that persist beyond the active phase of the collaborative.
Also in JHM this month
The effect of an inpatient smoking cessation treatment program on hospital readmissions and length of stayAUTHORS: Eline M. van den Broek-Altenburg, MS, MA, Adam J. Atherly, PhD
Treatment trends and outcomes in healthcare-associated pneumoniaAUTHORS: Sarah Haessler, MD; Tara Lagu, MD, MPH; Peter K. Lindenauer, MD, MSc; Daniel J. Skiest, MD; Aruna Priya, MA, MSc; Penelope S. Pekow, PhD; Marya D. Zilberberg, MD, MPH; Thomas L. Higgins, MD, MBA; Michael B. Rothberg, MD, MPH
What’s the purpose of rounds? A qualitative study examining the perceptions of faculty and studentsAUTHORS: Oliver Hulland; Jeanne Farnan, MD, MHPE; Raphael Rabinowitz; Lisa Kearns, MD, MS; Michele Long, MD; Bradley Monash, MD; Priti Bhansali, MD; H. Barrett Fromme, MD, MHPE
Association between anemia and fatigue in hospitalized patients: does the measure of anemia matter?AUTHORS: Micah T. Prochaska, MD, MS; Richard Newcomb, BA; Graham Block, BA; Brian Park, BA; David O. Meltzer MD, PhD
Helping seniors plan for posthospital discharge needs before a hospitalization occurs: Results from the randomized control trial of planyourlifespan.orgAUTHORS: Lee A. Lindquist, MD, MPH, MBA; Vanessa Ramirez-Zohfeld, MPH; Priya D. Sunkara, MA; Chris Forcucci, RN, BSN; Dianne S. Campbell, BS; Phyllis Mitzen, MA; Jody D. Ciolino, PhD; Gayle Kricke, MSW; Anne Seltzer, LSW; Ana V. Ramirez, BA; Kenzie A. Cameron, PhD, MPH
Female family physicians come up short in burnout gender divide
MONTREAL – Female family physicians report more burnout and fewer self-care activities than their male colleagues, according to the results of a survey that found a significant gender divide in physician wellness.
Female respondents to the Texas-wide electronic survey of practicing physicians and residents reported more emotional exhaustion (P = .004) and higher levels of work stress (P = .009) than their male colleagues. Additionally, they reported sleeping less (P = .009), exercising less (P = .001), and eating healthy food less often (P = .005).
In an interview, Dr. Holder said she and her colleagues sent electronic surveys to family physicians, using the Residency Research Network of Texas champion at each of 11 family medicine residency sites. The champion helped with administration to residents, and also engaged community-based physicians in their region to complete the survey.
A total of 324 physicians completed the survey; 54% were female. The female respondents were younger (P = .001) and less likely to be married (P = .019) than the male physicians who responded.
A high level of emotional exhaustion, as assessed by responses on the Maslach Burnout Inventory, was reported by more than a third of physician respondents. Male respondents, however, were more likely to endorse factors protective against burnout, including feeling a higher level of personal accomplishment (P = .004) and having more resilience (P = .002). They also were more likely to participate in activities outside of work (P = .007).
Dr. Holder said she was surprised by the pervasively higher rates of burnout and lower levels of self-care the survey revealed among family physicians in Texas. She would have been less surprised to see the association in female physicians with children, but, she said, unpublished data didn’t bear that association out.
“Creating wellness programs during residency that are aimed at teaching physicians to incorporate self-care into their routines, especially females, may lead to decreased rates of burnout later in physicians’ careers,” said Dr. Holder.
In a discussion during the poster session, Dr. Holder, who is the associate program director for the Baylor Family Medicine residency program in Garland, Tex., said that she herself tries to make room for exercise in a busy schedule and eats so healthily that her residents tease her about it. It’s important to provide positive role modeling for residents, both male and female alike, during their training years, she said.
Dr. Holder reported no relevant financial conflicts of interest.
koakes@frontlinemedcom.com
On Twitter @karioakes
MONTREAL – Female family physicians report more burnout and fewer self-care activities than their male colleagues, according to the results of a survey that found a significant gender divide in physician wellness.
Female respondents to the Texas-wide electronic survey of practicing physicians and residents reported more emotional exhaustion (P = .004) and higher levels of work stress (P = .009) than their male colleagues. Additionally, they reported sleeping less (P = .009), exercising less (P = .001), and eating healthy food less often (P = .005).
In an interview, Dr. Holder said she and her colleagues sent electronic surveys to family physicians, using the Residency Research Network of Texas champion at each of 11 family medicine residency sites. The champion helped with administration to residents, and also engaged community-based physicians in their region to complete the survey.
A total of 324 physicians completed the survey; 54% were female. The female respondents were younger (P = .001) and less likely to be married (P = .019) than the male physicians who responded.
A high level of emotional exhaustion, as assessed by responses on the Maslach Burnout Inventory, was reported by more than a third of physician respondents. Male respondents, however, were more likely to endorse factors protective against burnout, including feeling a higher level of personal accomplishment (P = .004) and having more resilience (P = .002). They also were more likely to participate in activities outside of work (P = .007).
Dr. Holder said she was surprised by the pervasively higher rates of burnout and lower levels of self-care the survey revealed among family physicians in Texas. She would have been less surprised to see the association in female physicians with children, but, she said, unpublished data didn’t bear that association out.
“Creating wellness programs during residency that are aimed at teaching physicians to incorporate self-care into their routines, especially females, may lead to decreased rates of burnout later in physicians’ careers,” said Dr. Holder.
In a discussion during the poster session, Dr. Holder, who is the associate program director for the Baylor Family Medicine residency program in Garland, Tex., said that she herself tries to make room for exercise in a busy schedule and eats so healthily that her residents tease her about it. It’s important to provide positive role modeling for residents, both male and female alike, during their training years, she said.
Dr. Holder reported no relevant financial conflicts of interest.
koakes@frontlinemedcom.com
On Twitter @karioakes
MONTREAL – Female family physicians report more burnout and fewer self-care activities than their male colleagues, according to the results of a survey that found a significant gender divide in physician wellness.
Female respondents to the Texas-wide electronic survey of practicing physicians and residents reported more emotional exhaustion (P = .004) and higher levels of work stress (P = .009) than their male colleagues. Additionally, they reported sleeping less (P = .009), exercising less (P = .001), and eating healthy food less often (P = .005).
In an interview, Dr. Holder said she and her colleagues sent electronic surveys to family physicians, using the Residency Research Network of Texas champion at each of 11 family medicine residency sites. The champion helped with administration to residents, and also engaged community-based physicians in their region to complete the survey.
A total of 324 physicians completed the survey; 54% were female. The female respondents were younger (P = .001) and less likely to be married (P = .019) than the male physicians who responded.
A high level of emotional exhaustion, as assessed by responses on the Maslach Burnout Inventory, was reported by more than a third of physician respondents. Male respondents, however, were more likely to endorse factors protective against burnout, including feeling a higher level of personal accomplishment (P = .004) and having more resilience (P = .002). They also were more likely to participate in activities outside of work (P = .007).
Dr. Holder said she was surprised by the pervasively higher rates of burnout and lower levels of self-care the survey revealed among family physicians in Texas. She would have been less surprised to see the association in female physicians with children, but, she said, unpublished data didn’t bear that association out.
“Creating wellness programs during residency that are aimed at teaching physicians to incorporate self-care into their routines, especially females, may lead to decreased rates of burnout later in physicians’ careers,” said Dr. Holder.
In a discussion during the poster session, Dr. Holder, who is the associate program director for the Baylor Family Medicine residency program in Garland, Tex., said that she herself tries to make room for exercise in a busy schedule and eats so healthily that her residents tease her about it. It’s important to provide positive role modeling for residents, both male and female alike, during their training years, she said.
Dr. Holder reported no relevant financial conflicts of interest.
koakes@frontlinemedcom.com
On Twitter @karioakes
AT NAPCRG 2017
Key clinical point:
Major finding: Female family physicians are more likely to experience emotional exhaustion than their male counterparts (P = .009).
Data source: A survey of 324 family physicians in Texas.
Disclosures: Dr. Holder reported no relevant financial conflicts of interest.
Mayo experts outline Waldenström macroglobulinemia management
, especially when rapid control is needed for bulky disease, according to treatment guidelines from a multidisciplinary expert panel.
The Mayo Clinic Cancer Center Myeloma, Amyloidosis, and Dysproteinemia and Lymphoma Disease-Oriented Groups, composed of experts who have collectively treated hundreds of patients with Waldenström macroglobulinemia, updated their recommendations for management of the condition in JAMA Oncology. It’s the first update from the group since 2010. The new treatment approaches are based on clinical and observational studies published or presented through December 2015 and consensus recommendations.
The Mayo group said dexamethasone-rituximab-cyclophosphamide can be an alternative treatment for patients with symptomatic Waldenström macroglobulinemia with a low disease burden. But because of an absence of data, the group said rituximab maintenance therapy is not recommended for routine use outside of clinical trials.
Rituximab monotherapy is contraindicated if patients have symptomatic hyperviscosity; without preemptive plasmapheresis, this treatment should be avoided in those with very high serum IgM. They recommended a prompt start of therapeutic plasma exchange for hyperviscosity syndrome, before starting cytoreductive treatment. But rituximab is indicated when patients have symptomatic mild to moderate anemia, symptomatic cryoglobulinemia (in combination with steroids), or hemolytic anemia that does not respond to corticosteroids.
In cases of first or second relapse, autologous stem cell transplantation should be considered in patients with chemosensitive disease who are eligible for transplant, especially when the first remission duration was less than 2 years. Patients with refractory Waldenström macroglobulinemia should not be offered autologous stem cell transplantation.
Read the full set of recommendations in JAMA Oncology (2017 Sep 1;3[9]:1257-65).
mschneider@frontlinemedcom.com
On Twitter @maryellenny
, especially when rapid control is needed for bulky disease, according to treatment guidelines from a multidisciplinary expert panel.
The Mayo Clinic Cancer Center Myeloma, Amyloidosis, and Dysproteinemia and Lymphoma Disease-Oriented Groups, composed of experts who have collectively treated hundreds of patients with Waldenström macroglobulinemia, updated their recommendations for management of the condition in JAMA Oncology. It’s the first update from the group since 2010. The new treatment approaches are based on clinical and observational studies published or presented through December 2015 and consensus recommendations.
The Mayo group said dexamethasone-rituximab-cyclophosphamide can be an alternative treatment for patients with symptomatic Waldenström macroglobulinemia with a low disease burden. But because of an absence of data, the group said rituximab maintenance therapy is not recommended for routine use outside of clinical trials.
Rituximab monotherapy is contraindicated if patients have symptomatic hyperviscosity; without preemptive plasmapheresis, this treatment should be avoided in those with very high serum IgM. They recommended a prompt start of therapeutic plasma exchange for hyperviscosity syndrome, before starting cytoreductive treatment. But rituximab is indicated when patients have symptomatic mild to moderate anemia, symptomatic cryoglobulinemia (in combination with steroids), or hemolytic anemia that does not respond to corticosteroids.
In cases of first or second relapse, autologous stem cell transplantation should be considered in patients with chemosensitive disease who are eligible for transplant, especially when the first remission duration was less than 2 years. Patients with refractory Waldenström macroglobulinemia should not be offered autologous stem cell transplantation.
Read the full set of recommendations in JAMA Oncology (2017 Sep 1;3[9]:1257-65).
mschneider@frontlinemedcom.com
On Twitter @maryellenny
, especially when rapid control is needed for bulky disease, according to treatment guidelines from a multidisciplinary expert panel.
The Mayo Clinic Cancer Center Myeloma, Amyloidosis, and Dysproteinemia and Lymphoma Disease-Oriented Groups, composed of experts who have collectively treated hundreds of patients with Waldenström macroglobulinemia, updated their recommendations for management of the condition in JAMA Oncology. It’s the first update from the group since 2010. The new treatment approaches are based on clinical and observational studies published or presented through December 2015 and consensus recommendations.
The Mayo group said dexamethasone-rituximab-cyclophosphamide can be an alternative treatment for patients with symptomatic Waldenström macroglobulinemia with a low disease burden. But because of an absence of data, the group said rituximab maintenance therapy is not recommended for routine use outside of clinical trials.
Rituximab monotherapy is contraindicated if patients have symptomatic hyperviscosity; without preemptive plasmapheresis, this treatment should be avoided in those with very high serum IgM. They recommended a prompt start of therapeutic plasma exchange for hyperviscosity syndrome, before starting cytoreductive treatment. But rituximab is indicated when patients have symptomatic mild to moderate anemia, symptomatic cryoglobulinemia (in combination with steroids), or hemolytic anemia that does not respond to corticosteroids.
In cases of first or second relapse, autologous stem cell transplantation should be considered in patients with chemosensitive disease who are eligible for transplant, especially when the first remission duration was less than 2 years. Patients with refractory Waldenström macroglobulinemia should not be offered autologous stem cell transplantation.
Read the full set of recommendations in JAMA Oncology (2017 Sep 1;3[9]:1257-65).
mschneider@frontlinemedcom.com
On Twitter @maryellenny
FROM JAMA ONCOLOGY