Although the last decade has brought appropriate increased interest in the diagnosis and treatment of postpartum depression, with screening initiatives across more than 40 states in place and even new medications being brought to market for treatment, far less attention has been given to diagnosis and treatment of a particularly serious psychiatric illness: postpartum psychosis.

Postpartum psychosis is relatively rare, with an incidence of 1 in 1,000 births, but it is one of the most serious complications of modern obstetrics. Clinically, women can experience rapid mood changes, most often with the presentation that is consistent with a manic-like psychosis, with associated symptoms of delusional thinking, hallucinations, paranoia and either depression or elation, or an amalgam of these so-called “mixed symptoms.” Onset of symptoms typically is early, within 72 hours as is classically described, but may have a somewhat later time of onset in some women.

Many investigators have studied risk factors for postpartum psychosis, and it has been well established that a history of mood disorder, particularly bipolar disorder, is one of the strongest predictors of risk for postpartum psychosis. Women with histories of postpartum psychosis are at very high risk of recurrence, with as many as 70%-90% of women experiencing recurrence if not prophylaxed with an appropriate agent. From a clinical point of view, women with postpartum psychosis typically are hospitalized, given that this is both a psychiatric and potential obstetrical emergency. In fact, the data would suggest that although postpartum suicide and infanticide are not common, they can be a tragic concomitant of postpartum psychosis (Am J Psychiatry. 2016 Dec 1;173[12]:1179-88).

A great amount of interest has been placed on the etiology of postpartum psychosis, as it’s a dramatic presentation with very rapid onset in the acute postpartum period. A rich evidence base with respect to an algorithm of treatment that maximizes likelihood of full recovery or sustaining of euthymia after recovery is limited. Few studies have looked systematically at the optimum way to treat postpartum psychosis. Clinical wisdom has dictated that, given the dramatic symptoms with which these patients present, most patients are treated with lithium and an antipsychotic medication as if they have a manic-like psychosis. It may take brief or extended periods of time for patients to stabilize. Once they are stabilized, one of the most challenging questions for clinicians is how long to treat. Again, an evidence base clearly informing this question is lacking.

Over the years, many clinicians have treated patients with postpartum psychosis as if they have bipolar disorder, given the index presentation of the illness, so some of these patients are treated with antimanic drugs indefinitely. However, clinical experience from several centers that treat women with postpartum psychosis suggests that in remitted patients, a proportion of them may be able to taper and discontinue treatment, then sustain well-being for protracted periods.

One obstacle with respect to treatment of postpartum psychosis derives from the short length of stay after delivery for many women. Some women who present with symptoms of postpartum psychosis in the first 24-48 hours frequently are managed with direct admission to an inpatient psychiatric service. But others may not develop symptoms until they are home, which may place both mother and newborn at risk.

Given that the risk for recurrent postpartum psychosis is so great (70%-90%), women with histories of postpartum psychosis invariably are prophylaxed with mood stabilizer prior to delivery in a subsequent pregnancy. In our own center, we have published on the value of such prophylactic intervention, not just in women with postpartum psychosis, but in women with bipolar disorder, who are, as noted, at great risk for developing postpartum psychotic symptoms (Am J Psychiatry. 1995 Nov;152[11]:1641-5.)

Although postpartum psychosis may be rare, over the last 3 decades we have seen a substantial number of women with postpartum psychosis and have been fascinated with the spectrum of symptoms with which some women with postpartum psychotic illness present. We also have been impressed with the time required for some women to recompensate from their illness and the course of their disorder after they have seemingly remitted. Some women appear to be able to discontinue treatment as noted above; others, particularly if there is any history of bipolar disorder, need to be maintained on treatment with mood stabilizer indefinitely.

To better understand the phenomenology of postpartum psychosis, as well as the longitudinal course of the illness, in 2019, the Mass General Hospital Postpartum Psychosis Project (MGHP3) was established. The project is conducted as a hospital-based registry where women with histories of postpartum psychosis over the last decade are invited to participate in an in-depth interview to understand both symptoms and course of underlying illness. This is complemented by obtaining a sample of saliva, which is used for genetic testing to try to identify a genetic underpinning associated with postpartum psychosis, as the question of genetic etiology of postpartum psychosis is still an open one.

As part of the MGHP3 project, clinicians across the country are able to contact perinatal psychiatrists in our center with expertise in the treatment of postpartum psychosis. Our psychiatrists also can counsel clinicians on issues regarding long-term management of postpartum psychosis because for many, knowledge of precisely how to manage this disorder or the follow-up treatment may be incomplete.

From a clinical point of view, the relevant questions really include not only acute treatment, which has already been outlined, but also the issue of duration of treatment. While some patients may be able to taper and discontinue treatment after, for example, a year of being totally well, to date we are unable to know who those patients are. We tend to be more conservative in our own center and treat patients with puerperal psychosis for a more protracted period of time, usually over several years. We also ask women about their family history of bipolar disorder or postpartum psychosis. Depending on the clinical course (if the patient really has sustained euthymia), we consider slow taper and ultimate discontinuation. As always, treatment decisions are tailored to individual clinical history, course, and patient wishes.

Postpartum psychosis remains one of the most serious illnesses that we find in reproductive psychiatry, and incomplete attention has been given to this devastating illness, which we read about periodically in newspapers and magazines. Greater understanding of postpartum psychosis will lead to a more precision-like psychiatric approach, tailoring treatment to the invariable heterogeneity of this illness.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at obnews@mdedge.com.

Although the last decade has brought appropriate increased interest in the diagnosis and treatment of postpartum depression, with screening initiatives across more than 40 states in place and even new medications being brought to market for treatment, far less attention has been given to diagnosis and treatment of a particularly serious psychiatric illness: postpartum psychosis.

Postpartum psychosis is relatively rare, with an incidence of 1 in 1,000 births, but it is one of the most serious complications of modern obstetrics. Clinically, women can experience rapid mood changes, most often with the presentation that is consistent with a manic-like psychosis, with associated symptoms of delusional thinking, hallucinations, paranoia and either depression or elation, or an amalgam of these so-called “mixed symptoms.” Onset of symptoms typically is early, within 72 hours as is classically described, but may have a somewhat later time of onset in some women.

Many investigators have studied risk factors for postpartum psychosis, and it has been well established that a history of mood disorder, particularly bipolar disorder, is one of the strongest predictors of risk for postpartum psychosis. Women with histories of postpartum psychosis are at very high risk of recurrence, with as many as 70%-90% of women experiencing recurrence if not prophylaxed with an appropriate agent. From a clinical point of view, women with postpartum psychosis typically are hospitalized, given that this is both a psychiatric and potential obstetrical emergency. In fact, the data would suggest that although postpartum suicide and infanticide are not common, they can be a tragic concomitant of postpartum psychosis (Am J Psychiatry. 2016 Dec 1;173[12]:1179-88).

A great amount of interest has been placed on the etiology of postpartum psychosis, as it’s a dramatic presentation with very rapid onset in the acute postpartum period. A rich evidence base with respect to an algorithm of treatment that maximizes likelihood of full recovery or sustaining of euthymia after recovery is limited. Few studies have looked systematically at the optimum way to treat postpartum psychosis. Clinical wisdom has dictated that, given the dramatic symptoms with which these patients present, most patients are treated with lithium and an antipsychotic medication as if they have a manic-like psychosis. It may take brief or extended periods of time for patients to stabilize. Once they are stabilized, one of the most challenging questions for clinicians is how long to treat. Again, an evidence base clearly informing this question is lacking.

Over the years, many clinicians have treated patients with postpartum psychosis as if they have bipolar disorder, given the index presentation of the illness, so some of these patients are treated with antimanic drugs indefinitely. However, clinical experience from several centers that treat women with postpartum psychosis suggests that in remitted patients, a proportion of them may be able to taper and discontinue treatment, then sustain well-being for protracted periods.

One obstacle with respect to treatment of postpartum psychosis derives from the short length of stay after delivery for many women. Some women who present with symptoms of postpartum psychosis in the first 24-48 hours frequently are managed with direct admission to an inpatient psychiatric service. But others may not develop symptoms until they are home, which may place both mother and newborn at risk.

Given that the risk for recurrent postpartum psychosis is so great (70%-90%), women with histories of postpartum psychosis invariably are prophylaxed with mood stabilizer prior to delivery in a subsequent pregnancy. In our own center, we have published on the value of such prophylactic intervention, not just in women with postpartum psychosis, but in women with bipolar disorder, who are, as noted, at great risk for developing postpartum psychotic symptoms (Am J Psychiatry. 1995 Nov;152[11]:1641-5.)

Although postpartum psychosis may be rare, over the last 3 decades we have seen a substantial number of women with postpartum psychosis and have been fascinated with the spectrum of symptoms with which some women with postpartum psychotic illness present. We also have been impressed with the time required for some women to recompensate from their illness and the course of their disorder after they have seemingly remitted. Some women appear to be able to discontinue treatment as noted above; others, particularly if there is any history of bipolar disorder, need to be maintained on treatment with mood stabilizer indefinitely.

To better understand the phenomenology of postpartum psychosis, as well as the longitudinal course of the illness, in 2019, the Mass General Hospital Postpartum Psychosis Project (MGHP3) was established. The project is conducted as a hospital-based registry where women with histories of postpartum psychosis over the last decade are invited to participate in an in-depth interview to understand both symptoms and course of underlying illness. This is complemented by obtaining a sample of saliva, which is used for genetic testing to try to identify a genetic underpinning associated with postpartum psychosis, as the question of genetic etiology of postpartum psychosis is still an open one.

As part of the MGHP3 project, clinicians across the country are able to contact perinatal psychiatrists in our center with expertise in the treatment of postpartum psychosis. Our psychiatrists also can counsel clinicians on issues regarding long-term management of postpartum psychosis because for many, knowledge of precisely how to manage this disorder or the follow-up treatment may be incomplete.

From a clinical point of view, the relevant questions really include not only acute treatment, which has already been outlined, but also the issue of duration of treatment. While some patients may be able to taper and discontinue treatment after, for example, a year of being totally well, to date we are unable to know who those patients are. We tend to be more conservative in our own center and treat patients with puerperal psychosis for a more protracted period of time, usually over several years. We also ask women about their family history of bipolar disorder or postpartum psychosis. Depending on the clinical course (if the patient really has sustained euthymia), we consider slow taper and ultimate discontinuation. As always, treatment decisions are tailored to individual clinical history, course, and patient wishes.

Postpartum psychosis remains one of the most serious illnesses that we find in reproductive psychiatry, and incomplete attention has been given to this devastating illness, which we read about periodically in newspapers and magazines. Greater understanding of postpartum psychosis will lead to a more precision-like psychiatric approach, tailoring treatment to the invariable heterogeneity of this illness.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at obnews@mdedge.com.

Although the last decade has brought appropriate increased interest in the diagnosis and treatment of postpartum depression, with screening initiatives across more than 40 states in place and even new medications being brought to market for treatment, far less attention has been given to diagnosis and treatment of a particularly serious psychiatric illness: postpartum psychosis.

Postpartum psychosis is relatively rare, with an incidence of 1 in 1,000 births, but it is one of the most serious complications of modern obstetrics. Clinically, women can experience rapid mood changes, most often with the presentation that is consistent with a manic-like psychosis, with associated symptoms of delusional thinking, hallucinations, paranoia and either depression or elation, or an amalgam of these so-called “mixed symptoms.” Onset of symptoms typically is early, within 72 hours as is classically described, but may have a somewhat later time of onset in some women.

Many investigators have studied risk factors for postpartum psychosis, and it has been well established that a history of mood disorder, particularly bipolar disorder, is one of the strongest predictors of risk for postpartum psychosis. Women with histories of postpartum psychosis are at very high risk of recurrence, with as many as 70%-90% of women experiencing recurrence if not prophylaxed with an appropriate agent. From a clinical point of view, women with postpartum psychosis typically are hospitalized, given that this is both a psychiatric and potential obstetrical emergency. In fact, the data would suggest that although postpartum suicide and infanticide are not common, they can be a tragic concomitant of postpartum psychosis (Am J Psychiatry. 2016 Dec 1;173[12]:1179-88).

A great amount of interest has been placed on the etiology of postpartum psychosis, as it’s a dramatic presentation with very rapid onset in the acute postpartum period. A rich evidence base with respect to an algorithm of treatment that maximizes likelihood of full recovery or sustaining of euthymia after recovery is limited. Few studies have looked systematically at the optimum way to treat postpartum psychosis. Clinical wisdom has dictated that, given the dramatic symptoms with which these patients present, most patients are treated with lithium and an antipsychotic medication as if they have a manic-like psychosis. It may take brief or extended periods of time for patients to stabilize. Once they are stabilized, one of the most challenging questions for clinicians is how long to treat. Again, an evidence base clearly informing this question is lacking.

Over the years, many clinicians have treated patients with postpartum psychosis as if they have bipolar disorder, given the index presentation of the illness, so some of these patients are treated with antimanic drugs indefinitely. However, clinical experience from several centers that treat women with postpartum psychosis suggests that in remitted patients, a proportion of them may be able to taper and discontinue treatment, then sustain well-being for protracted periods.

One obstacle with respect to treatment of postpartum psychosis derives from the short length of stay after delivery for many women. Some women who present with symptoms of postpartum psychosis in the first 24-48 hours frequently are managed with direct admission to an inpatient psychiatric service. But others may not develop symptoms until they are home, which may place both mother and newborn at risk.

Given that the risk for recurrent postpartum psychosis is so great (70%-90%), women with histories of postpartum psychosis invariably are prophylaxed with mood stabilizer prior to delivery in a subsequent pregnancy. In our own center, we have published on the value of such prophylactic intervention, not just in women with postpartum psychosis, but in women with bipolar disorder, who are, as noted, at great risk for developing postpartum psychotic symptoms (Am J Psychiatry. 1995 Nov;152[11]:1641-5.)

Although postpartum psychosis may be rare, over the last 3 decades we have seen a substantial number of women with postpartum psychosis and have been fascinated with the spectrum of symptoms with which some women with postpartum psychotic illness present. We also have been impressed with the time required for some women to recompensate from their illness and the course of their disorder after they have seemingly remitted. Some women appear to be able to discontinue treatment as noted above; others, particularly if there is any history of bipolar disorder, need to be maintained on treatment with mood stabilizer indefinitely.

To better understand the phenomenology of postpartum psychosis, as well as the longitudinal course of the illness, in 2019, the Mass General Hospital Postpartum Psychosis Project (MGHP3) was established. The project is conducted as a hospital-based registry where women with histories of postpartum psychosis over the last decade are invited to participate in an in-depth interview to understand both symptoms and course of underlying illness. This is complemented by obtaining a sample of saliva, which is used for genetic testing to try to identify a genetic underpinning associated with postpartum psychosis, as the question of genetic etiology of postpartum psychosis is still an open one.

As part of the MGHP3 project, clinicians across the country are able to contact perinatal psychiatrists in our center with expertise in the treatment of postpartum psychosis. Our psychiatrists also can counsel clinicians on issues regarding long-term management of postpartum psychosis because for many, knowledge of precisely how to manage this disorder or the follow-up treatment may be incomplete.

From a clinical point of view, the relevant questions really include not only acute treatment, which has already been outlined, but also the issue of duration of treatment. While some patients may be able to taper and discontinue treatment after, for example, a year of being totally well, to date we are unable to know who those patients are. We tend to be more conservative in our own center and treat patients with puerperal psychosis for a more protracted period of time, usually over several years. We also ask women about their family history of bipolar disorder or postpartum psychosis. Depending on the clinical course (if the patient really has sustained euthymia), we consider slow taper and ultimate discontinuation. As always, treatment decisions are tailored to individual clinical history, course, and patient wishes.

Postpartum psychosis remains one of the most serious illnesses that we find in reproductive psychiatry, and incomplete attention has been given to this devastating illness, which we read about periodically in newspapers and magazines. Greater understanding of postpartum psychosis will lead to a more precision-like psychiatric approach, tailoring treatment to the invariable heterogeneity of this illness.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at obnews@mdedge.com.

SNOWMASS, COLO. – The concept that silent myocardial ischemia is clinically detrimental has fallen by the wayside, and routine screening for this phenomenon can no longer be recommended, Patrick T. O’Gara, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

What a difference a decade or 2 can make.

“Think about where we were 25 years ago, when we worried about people who had transient ST-segment depression without angina on Holter monitoring. We would wig out, chase them down the street, try to tackle them and load them up with medications and think about balloon [percutaneous transluminal coronary angioplasty]. And now we’re at the point where it doesn’t seem to help with respect to quality of life, let alone death or myocardial infarction,” observed Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

The end of the line for the now-discredited notion that silent ischemia carries clinical significance approaching that of ischemia plus angina pectoris was the landmark ISCHEMIA trial, reported in November 2019 at the annual scientific sessions of the American Heart Association. This randomized trial asked the question: Is there any high-risk subgroup of patients with stable ischemic heart disease not involving the left main coronary artery for whom a strategy of routine revascularization improves hard outcomes in the current era of highly effective, guideline-directed medical therapy?

The answer turned out to be no. At 5 years of follow-up of 5,179 randomized patients with baseline stable coronary artery disease (CAD) and rigorously determined baseline moderate or severe ischemia affecting more than 10% of the myocardium, there was no difference between patients randomized to routine revascularization plus optimal medical therapy versus those on optimal medical therapy alone in the primary combined outcome of cardiovascular death, MI, heart failure, cardiac arrest, or hospitalization for unstable angina.

Of note, 35% of participants in the ISCHEMIA trial had moderate or severe silent ischemia. Like those who had angina, they achieved no additional benefit from a strategy of routine revascularization in terms of the primary outcome. ISCHEMIA participants with angina did show significant and durable improvements in quality of life and angina control with routine revascularization; however, those with silent ischemia showed little or no such improvement with an invasive strategy.

That being said, Dr. O’Gara added that he supports the ISCHEMIA investigators’ efforts to obtain funding from the National Institutes of Health for another 5 years or so of follow-up in order to determine whether revascularization actually does lead to improvement in the hard outcomes.

“Remember, in the STICH trial it took 10 years to show superiority of CABG [coronary artery bypass surgery] versus medical therapy to treat ischemic cardiomyopathy [N Engl J Med 2016; 374:1511-20]. My own view is that it’s too premature to throw the baby out with the bathwater. I think shared decision making is still very important, and I think, for many of our patients, relief of angina and improved quality of life are legitimate reasons in a low-risk situation with a good interventionalist to proceed,” he said.

Dr. O’Gara traced the history of medical thinking about silent ischemia. The notion that silent ischemia carried a clinical significance comparable with ischemia with angina gained wide credence more than 30 years ago, when investigators from the National Institutes of Health–sponsored Coronary Artery Surgery Study registry reported: “Patients with either silent or symptomatic ischemia during exercise testing have a similar risk of developing an acute myocardial infarction or sudden death – except in the three-vessel CAD subgroup, where the risk is greater in silent ischemia” (Am J Cardiol. 1988 Dec 1;62[17]:1155-8).

“This was a very important observation and led to many, many recommendations about screening and making sure that you took the expression of ST-segment depression on exercise treadmill testing pretty seriously, even if your patient did not have angina,” Dr. O’Gara recalled.

The prevailing wisdom that silent ischemia was detrimental took a hit in the Detection of Ischemia in Asymptomatic Diabetics (DIAC) trial. DIAC was conducted at a time when it had become clear that type 2 diabetes was a condition associated with increased cardiovascular risk, and that various methods of imaging were more accurate than treadmill exercise testing for the detection of underlying CAD. But when 1,123 DIAC participants with type 2 diabetes were randomized to screening with adenosine-stress radionuclide myocardial perfusion imaging or not and prospectively followed for roughly 5 years, it turned out there was no between-group difference in cardiac death or MI (JAMA. 2009 Apr 15;301[15]:1547-55).

“This pretty much put the lid on going out of one’s way to do routine screening of this nature in persons with diabetes who were considered to be at higher than average risk for the development of coronary disease,” the cardiologist commented.

Another fissure in the idea that silent ischemia was worth searching for and treating came from CLARIFY, an observational international registry of more than 20,000 individuals with stable CAD, roughly 12% of whom had silent ischemia, a figure in line with the prevalence reported in other studies. The 2-year rate of cardiovascular death or MI in the group with silent ischemia didn’t differ from the rate in patients with neither angina nor provocable ischemia. In contrast, rates of cardiovascular death or MI were significantly higher in the groups with angina but no ischemia or angina with ischemia (JAMA Intern Med. 2014 Oct;174[10]:1651-9).

“There’s something about the expression of angina that’s a very key clinical marker,” Dr. O’Gara observed.

He noted that just a few months before the ISCHEMIA trial results were released, a report from the far-smaller, randomized second Medicine, Angioplasty, or Surgery Study “threw cold water” on the notion that stress-induced ischemia in patients with multivessel CAD is a bad thing. Over 10 years of follow-up, the risk of major adverse cardiovascular events or deterioration in left ventricular function was identical in patients with or without baseline ischemia on stress testing performed after percutaneous coronary intervention, CABG surgery, or initiation of medical therapy (JAMA Intern Med. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2227).
 

What the guidelines say

The 6-year-old U.S. guidelines on the diagnosis and management of patients with stable ischemic heart disease are clearly out of date on the topic of silent ischemia (Circulation. 2014 Nov 4;130[19]:1749-67). The recommendations are based on expert opinion formed prior to the massive amount of new evidence that has since become available. For example, the current guidelines state as a class IIa, level of evidence C recommendation that exercise or pharmacologic stress can be useful for follow-up assessment at 2-year or greater intervals in patients with stable ischemic heart disease with prior evidence of silent ischemia.

“This is a very weak recommendation. The class of recommendation says it would be reasonable, but in the absence of an evidence base and in light of newer information, I’m not sure that it approaches even a class IIa level of recommendation,” according to Dr. O’Gara.

The 2019 European Society of Cardiology guidelines on chronic coronary syndromes are similarly weak on silent ischemia. The European guidelines state that patients with diabetes or chronic kidney disease may have a higher burden of silent ischemia, might be at higher risk for atherosclerotic cardiovascular disease events, and that periodic ECGs and functional testing every 3-5 years might be considered.

“Obviously there’s a lot of leeway there in how you wish to interpret that,” Dr. O’Gara said. “And this did not rise to the level where they’d put it in the table of recommendations, but it’s simply included as part of the explanatory text.”
 

What’s coming next in stable ischemic heart disease

“Nowadays all the rage has to do with coronary microvascular dysfunction,” according to Dr. O’Gara. “I think all of the research interest currently is focused on the coronary microcirculation as perhaps the next frontier in our understanding of why it is that ischemia can occur in the absence of epicardial coronary disease.”

He highly recommended a review article entitled: “Reappraisal of Ischemic Heart Disease,” in which an international trio of prominent cardiologists asserted that coronary microvascular dysfunction not only plays a pivotal pathogenic role in angina pectoris, but also in a phenomenon known as microvascular angina – that is, angina in the absence of obstructive CAD. Microvascular angina may explain the roughly one-third of patients who experience acute coronary syndrome without epicardial coronary artery stenosis or thrombosis. The authors delved into the structural and functional mechanisms underlying coronary microvascular dysfunction, while noting that effective treatment of this common phenomenon remains a major unmet need (Circulation. 2018 Oct 2;138[14]:1463-80).

Dr. O’Gara reported receiving funding from the National Heart, Lung, and Blood Institute; from Medtronic in conjunction with the ongoing pivotal APOLLO transcatheter mitral valve replacement trial; from Edwards Lifesciences for the ongoing EARLY TAVR trial; and from Medtrace Pharma, a Danish company developing an innovative form of PET diagnostic imaging.

bjancin@mdedge.com

SNOWMASS, COLO. – The concept that silent myocardial ischemia is clinically detrimental has fallen by the wayside, and routine screening for this phenomenon can no longer be recommended, Patrick T. O’Gara, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

What a difference a decade or 2 can make.

“Think about where we were 25 years ago, when we worried about people who had transient ST-segment depression without angina on Holter monitoring. We would wig out, chase them down the street, try to tackle them and load them up with medications and think about balloon [percutaneous transluminal coronary angioplasty]. And now we’re at the point where it doesn’t seem to help with respect to quality of life, let alone death or myocardial infarction,” observed Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

The end of the line for the now-discredited notion that silent ischemia carries clinical significance approaching that of ischemia plus angina pectoris was the landmark ISCHEMIA trial, reported in November 2019 at the annual scientific sessions of the American Heart Association. This randomized trial asked the question: Is there any high-risk subgroup of patients with stable ischemic heart disease not involving the left main coronary artery for whom a strategy of routine revascularization improves hard outcomes in the current era of highly effective, guideline-directed medical therapy?

The answer turned out to be no. At 5 years of follow-up of 5,179 randomized patients with baseline stable coronary artery disease (CAD) and rigorously determined baseline moderate or severe ischemia affecting more than 10% of the myocardium, there was no difference between patients randomized to routine revascularization plus optimal medical therapy versus those on optimal medical therapy alone in the primary combined outcome of cardiovascular death, MI, heart failure, cardiac arrest, or hospitalization for unstable angina.

Of note, 35% of participants in the ISCHEMIA trial had moderate or severe silent ischemia. Like those who had angina, they achieved no additional benefit from a strategy of routine revascularization in terms of the primary outcome. ISCHEMIA participants with angina did show significant and durable improvements in quality of life and angina control with routine revascularization; however, those with silent ischemia showed little or no such improvement with an invasive strategy.

That being said, Dr. O’Gara added that he supports the ISCHEMIA investigators’ efforts to obtain funding from the National Institutes of Health for another 5 years or so of follow-up in order to determine whether revascularization actually does lead to improvement in the hard outcomes.

“Remember, in the STICH trial it took 10 years to show superiority of CABG [coronary artery bypass surgery] versus medical therapy to treat ischemic cardiomyopathy [N Engl J Med 2016; 374:1511-20]. My own view is that it’s too premature to throw the baby out with the bathwater. I think shared decision making is still very important, and I think, for many of our patients, relief of angina and improved quality of life are legitimate reasons in a low-risk situation with a good interventionalist to proceed,” he said.

Dr. O’Gara traced the history of medical thinking about silent ischemia. The notion that silent ischemia carried a clinical significance comparable with ischemia with angina gained wide credence more than 30 years ago, when investigators from the National Institutes of Health–sponsored Coronary Artery Surgery Study registry reported: “Patients with either silent or symptomatic ischemia during exercise testing have a similar risk of developing an acute myocardial infarction or sudden death – except in the three-vessel CAD subgroup, where the risk is greater in silent ischemia” (Am J Cardiol. 1988 Dec 1;62[17]:1155-8).

“This was a very important observation and led to many, many recommendations about screening and making sure that you took the expression of ST-segment depression on exercise treadmill testing pretty seriously, even if your patient did not have angina,” Dr. O’Gara recalled.

The prevailing wisdom that silent ischemia was detrimental took a hit in the Detection of Ischemia in Asymptomatic Diabetics (DIAC) trial. DIAC was conducted at a time when it had become clear that type 2 diabetes was a condition associated with increased cardiovascular risk, and that various methods of imaging were more accurate than treadmill exercise testing for the detection of underlying CAD. But when 1,123 DIAC participants with type 2 diabetes were randomized to screening with adenosine-stress radionuclide myocardial perfusion imaging or not and prospectively followed for roughly 5 years, it turned out there was no between-group difference in cardiac death or MI (JAMA. 2009 Apr 15;301[15]:1547-55).

“This pretty much put the lid on going out of one’s way to do routine screening of this nature in persons with diabetes who were considered to be at higher than average risk for the development of coronary disease,” the cardiologist commented.

Another fissure in the idea that silent ischemia was worth searching for and treating came from CLARIFY, an observational international registry of more than 20,000 individuals with stable CAD, roughly 12% of whom had silent ischemia, a figure in line with the prevalence reported in other studies. The 2-year rate of cardiovascular death or MI in the group with silent ischemia didn’t differ from the rate in patients with neither angina nor provocable ischemia. In contrast, rates of cardiovascular death or MI were significantly higher in the groups with angina but no ischemia or angina with ischemia (JAMA Intern Med. 2014 Oct;174[10]:1651-9).

“There’s something about the expression of angina that’s a very key clinical marker,” Dr. O’Gara observed.

He noted that just a few months before the ISCHEMIA trial results were released, a report from the far-smaller, randomized second Medicine, Angioplasty, or Surgery Study “threw cold water” on the notion that stress-induced ischemia in patients with multivessel CAD is a bad thing. Over 10 years of follow-up, the risk of major adverse cardiovascular events or deterioration in left ventricular function was identical in patients with or without baseline ischemia on stress testing performed after percutaneous coronary intervention, CABG surgery, or initiation of medical therapy (JAMA Intern Med. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2227).
 

What the guidelines say

The 6-year-old U.S. guidelines on the diagnosis and management of patients with stable ischemic heart disease are clearly out of date on the topic of silent ischemia (Circulation. 2014 Nov 4;130[19]:1749-67). The recommendations are based on expert opinion formed prior to the massive amount of new evidence that has since become available. For example, the current guidelines state as a class IIa, level of evidence C recommendation that exercise or pharmacologic stress can be useful for follow-up assessment at 2-year or greater intervals in patients with stable ischemic heart disease with prior evidence of silent ischemia.

“This is a very weak recommendation. The class of recommendation says it would be reasonable, but in the absence of an evidence base and in light of newer information, I’m not sure that it approaches even a class IIa level of recommendation,” according to Dr. O’Gara.

The 2019 European Society of Cardiology guidelines on chronic coronary syndromes are similarly weak on silent ischemia. The European guidelines state that patients with diabetes or chronic kidney disease may have a higher burden of silent ischemia, might be at higher risk for atherosclerotic cardiovascular disease events, and that periodic ECGs and functional testing every 3-5 years might be considered.

“Obviously there’s a lot of leeway there in how you wish to interpret that,” Dr. O’Gara said. “And this did not rise to the level where they’d put it in the table of recommendations, but it’s simply included as part of the explanatory text.”
 

What’s coming next in stable ischemic heart disease

“Nowadays all the rage has to do with coronary microvascular dysfunction,” according to Dr. O’Gara. “I think all of the research interest currently is focused on the coronary microcirculation as perhaps the next frontier in our understanding of why it is that ischemia can occur in the absence of epicardial coronary disease.”

He highly recommended a review article entitled: “Reappraisal of Ischemic Heart Disease,” in which an international trio of prominent cardiologists asserted that coronary microvascular dysfunction not only plays a pivotal pathogenic role in angina pectoris, but also in a phenomenon known as microvascular angina – that is, angina in the absence of obstructive CAD. Microvascular angina may explain the roughly one-third of patients who experience acute coronary syndrome without epicardial coronary artery stenosis or thrombosis. The authors delved into the structural and functional mechanisms underlying coronary microvascular dysfunction, while noting that effective treatment of this common phenomenon remains a major unmet need (Circulation. 2018 Oct 2;138[14]:1463-80).

Dr. O’Gara reported receiving funding from the National Heart, Lung, and Blood Institute; from Medtronic in conjunction with the ongoing pivotal APOLLO transcatheter mitral valve replacement trial; from Edwards Lifesciences for the ongoing EARLY TAVR trial; and from Medtrace Pharma, a Danish company developing an innovative form of PET diagnostic imaging.

bjancin@mdedge.com

SNOWMASS, COLO. – The concept that silent myocardial ischemia is clinically detrimental has fallen by the wayside, and routine screening for this phenomenon can no longer be recommended, Patrick T. O’Gara, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

What a difference a decade or 2 can make.

“Think about where we were 25 years ago, when we worried about people who had transient ST-segment depression without angina on Holter monitoring. We would wig out, chase them down the street, try to tackle them and load them up with medications and think about balloon [percutaneous transluminal coronary angioplasty]. And now we’re at the point where it doesn’t seem to help with respect to quality of life, let alone death or myocardial infarction,” observed Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

The end of the line for the now-discredited notion that silent ischemia carries clinical significance approaching that of ischemia plus angina pectoris was the landmark ISCHEMIA trial, reported in November 2019 at the annual scientific sessions of the American Heart Association. This randomized trial asked the question: Is there any high-risk subgroup of patients with stable ischemic heart disease not involving the left main coronary artery for whom a strategy of routine revascularization improves hard outcomes in the current era of highly effective, guideline-directed medical therapy?

The answer turned out to be no. At 5 years of follow-up of 5,179 randomized patients with baseline stable coronary artery disease (CAD) and rigorously determined baseline moderate or severe ischemia affecting more than 10% of the myocardium, there was no difference between patients randomized to routine revascularization plus optimal medical therapy versus those on optimal medical therapy alone in the primary combined outcome of cardiovascular death, MI, heart failure, cardiac arrest, or hospitalization for unstable angina.

Of note, 35% of participants in the ISCHEMIA trial had moderate or severe silent ischemia. Like those who had angina, they achieved no additional benefit from a strategy of routine revascularization in terms of the primary outcome. ISCHEMIA participants with angina did show significant and durable improvements in quality of life and angina control with routine revascularization; however, those with silent ischemia showed little or no such improvement with an invasive strategy.

That being said, Dr. O’Gara added that he supports the ISCHEMIA investigators’ efforts to obtain funding from the National Institutes of Health for another 5 years or so of follow-up in order to determine whether revascularization actually does lead to improvement in the hard outcomes.

“Remember, in the STICH trial it took 10 years to show superiority of CABG [coronary artery bypass surgery] versus medical therapy to treat ischemic cardiomyopathy [N Engl J Med 2016; 374:1511-20]. My own view is that it’s too premature to throw the baby out with the bathwater. I think shared decision making is still very important, and I think, for many of our patients, relief of angina and improved quality of life are legitimate reasons in a low-risk situation with a good interventionalist to proceed,” he said.

Dr. O’Gara traced the history of medical thinking about silent ischemia. The notion that silent ischemia carried a clinical significance comparable with ischemia with angina gained wide credence more than 30 years ago, when investigators from the National Institutes of Health–sponsored Coronary Artery Surgery Study registry reported: “Patients with either silent or symptomatic ischemia during exercise testing have a similar risk of developing an acute myocardial infarction or sudden death – except in the three-vessel CAD subgroup, where the risk is greater in silent ischemia” (Am J Cardiol. 1988 Dec 1;62[17]:1155-8).

“This was a very important observation and led to many, many recommendations about screening and making sure that you took the expression of ST-segment depression on exercise treadmill testing pretty seriously, even if your patient did not have angina,” Dr. O’Gara recalled.

The prevailing wisdom that silent ischemia was detrimental took a hit in the Detection of Ischemia in Asymptomatic Diabetics (DIAC) trial. DIAC was conducted at a time when it had become clear that type 2 diabetes was a condition associated with increased cardiovascular risk, and that various methods of imaging were more accurate than treadmill exercise testing for the detection of underlying CAD. But when 1,123 DIAC participants with type 2 diabetes were randomized to screening with adenosine-stress radionuclide myocardial perfusion imaging or not and prospectively followed for roughly 5 years, it turned out there was no between-group difference in cardiac death or MI (JAMA. 2009 Apr 15;301[15]:1547-55).

“This pretty much put the lid on going out of one’s way to do routine screening of this nature in persons with diabetes who were considered to be at higher than average risk for the development of coronary disease,” the cardiologist commented.

Another fissure in the idea that silent ischemia was worth searching for and treating came from CLARIFY, an observational international registry of more than 20,000 individuals with stable CAD, roughly 12% of whom had silent ischemia, a figure in line with the prevalence reported in other studies. The 2-year rate of cardiovascular death or MI in the group with silent ischemia didn’t differ from the rate in patients with neither angina nor provocable ischemia. In contrast, rates of cardiovascular death or MI were significantly higher in the groups with angina but no ischemia or angina with ischemia (JAMA Intern Med. 2014 Oct;174[10]:1651-9).

“There’s something about the expression of angina that’s a very key clinical marker,” Dr. O’Gara observed.

He noted that just a few months before the ISCHEMIA trial results were released, a report from the far-smaller, randomized second Medicine, Angioplasty, or Surgery Study “threw cold water” on the notion that stress-induced ischemia in patients with multivessel CAD is a bad thing. Over 10 years of follow-up, the risk of major adverse cardiovascular events or deterioration in left ventricular function was identical in patients with or without baseline ischemia on stress testing performed after percutaneous coronary intervention, CABG surgery, or initiation of medical therapy (JAMA Intern Med. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2227).
 

What the guidelines say

The 6-year-old U.S. guidelines on the diagnosis and management of patients with stable ischemic heart disease are clearly out of date on the topic of silent ischemia (Circulation. 2014 Nov 4;130[19]:1749-67). The recommendations are based on expert opinion formed prior to the massive amount of new evidence that has since become available. For example, the current guidelines state as a class IIa, level of evidence C recommendation that exercise or pharmacologic stress can be useful for follow-up assessment at 2-year or greater intervals in patients with stable ischemic heart disease with prior evidence of silent ischemia.

“This is a very weak recommendation. The class of recommendation says it would be reasonable, but in the absence of an evidence base and in light of newer information, I’m not sure that it approaches even a class IIa level of recommendation,” according to Dr. O’Gara.

The 2019 European Society of Cardiology guidelines on chronic coronary syndromes are similarly weak on silent ischemia. The European guidelines state that patients with diabetes or chronic kidney disease may have a higher burden of silent ischemia, might be at higher risk for atherosclerotic cardiovascular disease events, and that periodic ECGs and functional testing every 3-5 years might be considered.

“Obviously there’s a lot of leeway there in how you wish to interpret that,” Dr. O’Gara said. “And this did not rise to the level where they’d put it in the table of recommendations, but it’s simply included as part of the explanatory text.”
 

What’s coming next in stable ischemic heart disease

“Nowadays all the rage has to do with coronary microvascular dysfunction,” according to Dr. O’Gara. “I think all of the research interest currently is focused on the coronary microcirculation as perhaps the next frontier in our understanding of why it is that ischemia can occur in the absence of epicardial coronary disease.”

He highly recommended a review article entitled: “Reappraisal of Ischemic Heart Disease,” in which an international trio of prominent cardiologists asserted that coronary microvascular dysfunction not only plays a pivotal pathogenic role in angina pectoris, but also in a phenomenon known as microvascular angina – that is, angina in the absence of obstructive CAD. Microvascular angina may explain the roughly one-third of patients who experience acute coronary syndrome without epicardial coronary artery stenosis or thrombosis. The authors delved into the structural and functional mechanisms underlying coronary microvascular dysfunction, while noting that effective treatment of this common phenomenon remains a major unmet need (Circulation. 2018 Oct 2;138[14]:1463-80).

Dr. O’Gara reported receiving funding from the National Heart, Lung, and Blood Institute; from Medtronic in conjunction with the ongoing pivotal APOLLO transcatheter mitral valve replacement trial; from Edwards Lifesciences for the ongoing EARLY TAVR trial; and from Medtrace Pharma, a Danish company developing an innovative form of PET diagnostic imaging.

bjancin@mdedge.com

If you’ve knocked yourself out to earn a Merit-Based Incentive Payment System (MIPS) bonus payment, it’s pretty safe to say that getting a 1.68% payment boost probably didn’t feel like a “win” that was worth the effort.

And although it saved you from having a negative 5% payment adjustment, many physicians don’t feel that it was worth the effort.

On Jan. 6, the Centers for Medicare & Medicaid Services announced the 2020 payouts for MIPS.

Based on 2018 participation, the bonus for those who scored a perfect 100 is only a 1.68% boost in Medicare reimbursement, slightly lower than last year’s 1.88%. This decline comes as no surprise as the agency leader admits: “As the program matures, we expect that the increases in the performance thresholds in future program years will create a smaller distribution of positive payment adjustments.” Overall, more than 97% of participants avoided having a negative 5% payment adjustment.

Indeed, these bonus monies are based on a short-term appropriation of extra funds from Congress. After these temporary funds are no longer available, there will be little, if any, monies to distribute as the program is based on a “losers-feed-the-winners” construct.

It may be very tempting for many physicians to decide to ignore MIPS, with the rationale that 1.68% is not worth the effort. But don’t let your foot off the gas pedal yet, since the penalty for not participating in 2020 is a substantial 9%. Physicians should make sure that they, at minimum, achieve the 45 points necessary to avoid that pitfall this reporting year.

However, it is certainly time to reconsider efforts to participate at the highest level.
 

Should you or shouldn’t you bother with MIPS?

Let’s say you have $75,000 in revenue from Medicare Part B per year. Depending on the services you offer in your practice, that equates to 500-750 encounters with Medicare beneficiaries per year. (A reminder that MIPS affects only Part B; Medicare Advantage plans do not partake in the program.)

The recent announcement reveals that perfection would equate to an additional $1,260 per year. That’s only if you received the full 100 points; if you were simply an “exceptional performer,” the government will allot an additional $157. That’s less than you get paid for a single office visit.

The difference between perfection and compliance is approximately $1,000. Failure to participate, however, knocks $6,750 off your bottom line. Clearly, that’s a substantial financial loss that would affect most practices. Obviously, the numbers change if you have higher – or lower – Medicare revenue, but it’s important to do the math.

Why? Physicians are spending a significant amount of money to comply with the program requirements. This includes substantial payments to registries – typically $200 to >$1,000 per year – to report the quality measures for the program; electronic health record (EHR) systems, many of which require additional funding for the “upgrade” to a MIPS-compatible system, are also a sizable investment.

These hard costs pale in comparison with the time spent on understanding the ever-changing requirements of the program and the process by which your practice will implement them. Take, for example, something as innocuous as the required “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

You first must understand the elements of the measure: What is a “referral loop?” When do we need to generate one? To whom shall it be sent? What needs to be included in “health information?” What is the electronic address to which we should route the information? How do we obtain that address? Then you must determine how your EHR system captures and reports it.

Only then comes the hard part: How are we going to implement this? That’s only one of more than a dozen required elements: six quality measures, two (to four) improvement activities, and four promoting interoperability requirements. Each one of these elements has a host of requirements, all listed on multipage specification sheets.

The government does not seem to be listening. John Cullen, MD, president of the American Academy of Family Physicians, testified at the Senate Finance Committee in May 2019 that MIPS “has created a burdensome and extremely complex program that has increased practice costs ... ” Yet, later that year, CMS issued another hefty ruling that outlines significant changes to the program, despite the fact that it’s in its fourth performance year.
 

Turning frustration into action

Frustration or even anger may be one reaction, but now is an opportune time to determine your investment in the program. At a minimum, it’s vital to understand and meet the threshold to avoid the penalty. It’s been shifting to date, but it’s now set at 9% for perpetuity.

First, it’s crucial to check on your participation status. CMS revealed that the participation database was recently corrected for so-called inconsistencies, so it pays to double-check. It only takes seconds: Insert your NPI in the QPP Participation Status Tool to determine your eligibility for 2020.

In 2020, the threshold to avoid the penalty is 45 points. To get the 45 points, practices must participate in two improvement activities, which is not difficult as there are 118 options. That will garner 15 points. Then there are 45 points available from the quality category; you need at least 30 to reach the 45-point threshold for penalty avoidance.
 

Smart MIPS hacks that can help you

To obtain the additional 30 points, turn your attention to the quality category. There are 268 quality measures; choose at least six to measure. If you report directly from your EHR system, you’ll get a bonus point for each reported measure, plus one just for trying. (There are a few other opportunities for bonus points, such as improving your scores over last year.) Those bonus points give you a base with which to work, but getting to 45 will require effort to report successfully on at least a couple of the measures.

The quality category has a total of 100 points available, which are converted to 45 toward your composite score. Since you need 30 to reach that magical 45 (if 15 were attained from improvement activities), that means you must come up with 75 points in the quality category. Between the bonus points and measuring a handful of measures successfully through the year, you’ll achieve this threshold.

There are two other categories in the program: promoting interoperability (PI) and cost. The PI category mirrors the old “meaningful use” program; however, it has become increasingly difficult over the years. If you think that you can meet the required elements, you can pick up 25 more points toward your composite score.

Cost is a bit of an unknown, as the scoring is based on a retrospective review of your claims. You’ll likely pick up a few more points on this 15-point category, but there’s no method to determine performance until after the reporting period. Therefore, be cautious about relying on this category.

The best MIPS hack, however, is if you are a small practice. CMS – remarkably – defines a “small practice” as 15 or fewer eligible professionals. If you qualify under this paradigm, you have multiple options to ease compliance:

Apply for a “hardship exemption” simply on the basis of being small; the exemption relates to the promoting operability category, shifting those points to the quality category.

Gain three points per quality measure, regardless of data completeness; this compares to just one point for other physicians.

Capture all of the points available from the Improvement Activities category by confirming participation with just a single activity. (This also applies to all physicians in rural or Health Professional Shortage Areas.)

In the event that you don’t qualify as a “small practice” or you’re still falling short of the requirements, CMS allows for the ultimate “out”: You can apply for exemption on the basis of an “extreme and uncontrollable circumstance.” The applications for these exceptions open this summer.

Unless you qualify for the program exemption, it’s important to keep pace with the program to ensure that you reach the 45-point threshold. It may not, however, be worthwhile to gear up for all 100 points unless your estimate of the potential return – and what it costs you to get there – reveals otherwise. MIPS is not going anywhere; the program is written into the law.

But that doesn’t mean that CMS can’t make tweaks and updates. Hopefully, the revisions won’t create even more administrative burden as the program is quickly turning into a big stick with only a small carrot at the end.

Elizabeth Woodcock is president of Woodcock & Associates in Atlanta. She has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

If you’ve knocked yourself out to earn a Merit-Based Incentive Payment System (MIPS) bonus payment, it’s pretty safe to say that getting a 1.68% payment boost probably didn’t feel like a “win” that was worth the effort.

And although it saved you from having a negative 5% payment adjustment, many physicians don’t feel that it was worth the effort.

On Jan. 6, the Centers for Medicare & Medicaid Services announced the 2020 payouts for MIPS.

Based on 2018 participation, the bonus for those who scored a perfect 100 is only a 1.68% boost in Medicare reimbursement, slightly lower than last year’s 1.88%. This decline comes as no surprise as the agency leader admits: “As the program matures, we expect that the increases in the performance thresholds in future program years will create a smaller distribution of positive payment adjustments.” Overall, more than 97% of participants avoided having a negative 5% payment adjustment.

Indeed, these bonus monies are based on a short-term appropriation of extra funds from Congress. After these temporary funds are no longer available, there will be little, if any, monies to distribute as the program is based on a “losers-feed-the-winners” construct.

It may be very tempting for many physicians to decide to ignore MIPS, with the rationale that 1.68% is not worth the effort. But don’t let your foot off the gas pedal yet, since the penalty for not participating in 2020 is a substantial 9%. Physicians should make sure that they, at minimum, achieve the 45 points necessary to avoid that pitfall this reporting year.

However, it is certainly time to reconsider efforts to participate at the highest level.
 

Should you or shouldn’t you bother with MIPS?

Let’s say you have $75,000 in revenue from Medicare Part B per year. Depending on the services you offer in your practice, that equates to 500-750 encounters with Medicare beneficiaries per year. (A reminder that MIPS affects only Part B; Medicare Advantage plans do not partake in the program.)

The recent announcement reveals that perfection would equate to an additional $1,260 per year. That’s only if you received the full 100 points; if you were simply an “exceptional performer,” the government will allot an additional $157. That’s less than you get paid for a single office visit.

The difference between perfection and compliance is approximately $1,000. Failure to participate, however, knocks $6,750 off your bottom line. Clearly, that’s a substantial financial loss that would affect most practices. Obviously, the numbers change if you have higher – or lower – Medicare revenue, but it’s important to do the math.

Why? Physicians are spending a significant amount of money to comply with the program requirements. This includes substantial payments to registries – typically $200 to >$1,000 per year – to report the quality measures for the program; electronic health record (EHR) systems, many of which require additional funding for the “upgrade” to a MIPS-compatible system, are also a sizable investment.

These hard costs pale in comparison with the time spent on understanding the ever-changing requirements of the program and the process by which your practice will implement them. Take, for example, something as innocuous as the required “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

You first must understand the elements of the measure: What is a “referral loop?” When do we need to generate one? To whom shall it be sent? What needs to be included in “health information?” What is the electronic address to which we should route the information? How do we obtain that address? Then you must determine how your EHR system captures and reports it.

Only then comes the hard part: How are we going to implement this? That’s only one of more than a dozen required elements: six quality measures, two (to four) improvement activities, and four promoting interoperability requirements. Each one of these elements has a host of requirements, all listed on multipage specification sheets.

The government does not seem to be listening. John Cullen, MD, president of the American Academy of Family Physicians, testified at the Senate Finance Committee in May 2019 that MIPS “has created a burdensome and extremely complex program that has increased practice costs ... ” Yet, later that year, CMS issued another hefty ruling that outlines significant changes to the program, despite the fact that it’s in its fourth performance year.
 

Turning frustration into action

Frustration or even anger may be one reaction, but now is an opportune time to determine your investment in the program. At a minimum, it’s vital to understand and meet the threshold to avoid the penalty. It’s been shifting to date, but it’s now set at 9% for perpetuity.

First, it’s crucial to check on your participation status. CMS revealed that the participation database was recently corrected for so-called inconsistencies, so it pays to double-check. It only takes seconds: Insert your NPI in the QPP Participation Status Tool to determine your eligibility for 2020.

In 2020, the threshold to avoid the penalty is 45 points. To get the 45 points, practices must participate in two improvement activities, which is not difficult as there are 118 options. That will garner 15 points. Then there are 45 points available from the quality category; you need at least 30 to reach the 45-point threshold for penalty avoidance.
 

Smart MIPS hacks that can help you

To obtain the additional 30 points, turn your attention to the quality category. There are 268 quality measures; choose at least six to measure. If you report directly from your EHR system, you’ll get a bonus point for each reported measure, plus one just for trying. (There are a few other opportunities for bonus points, such as improving your scores over last year.) Those bonus points give you a base with which to work, but getting to 45 will require effort to report successfully on at least a couple of the measures.

The quality category has a total of 100 points available, which are converted to 45 toward your composite score. Since you need 30 to reach that magical 45 (if 15 were attained from improvement activities), that means you must come up with 75 points in the quality category. Between the bonus points and measuring a handful of measures successfully through the year, you’ll achieve this threshold.

There are two other categories in the program: promoting interoperability (PI) and cost. The PI category mirrors the old “meaningful use” program; however, it has become increasingly difficult over the years. If you think that you can meet the required elements, you can pick up 25 more points toward your composite score.

Cost is a bit of an unknown, as the scoring is based on a retrospective review of your claims. You’ll likely pick up a few more points on this 15-point category, but there’s no method to determine performance until after the reporting period. Therefore, be cautious about relying on this category.

The best MIPS hack, however, is if you are a small practice. CMS – remarkably – defines a “small practice” as 15 or fewer eligible professionals. If you qualify under this paradigm, you have multiple options to ease compliance:

Apply for a “hardship exemption” simply on the basis of being small; the exemption relates to the promoting operability category, shifting those points to the quality category.

Gain three points per quality measure, regardless of data completeness; this compares to just one point for other physicians.

Capture all of the points available from the Improvement Activities category by confirming participation with just a single activity. (This also applies to all physicians in rural or Health Professional Shortage Areas.)

In the event that you don’t qualify as a “small practice” or you’re still falling short of the requirements, CMS allows for the ultimate “out”: You can apply for exemption on the basis of an “extreme and uncontrollable circumstance.” The applications for these exceptions open this summer.

Unless you qualify for the program exemption, it’s important to keep pace with the program to ensure that you reach the 45-point threshold. It may not, however, be worthwhile to gear up for all 100 points unless your estimate of the potential return – and what it costs you to get there – reveals otherwise. MIPS is not going anywhere; the program is written into the law.

But that doesn’t mean that CMS can’t make tweaks and updates. Hopefully, the revisions won’t create even more administrative burden as the program is quickly turning into a big stick with only a small carrot at the end.

Elizabeth Woodcock is president of Woodcock & Associates in Atlanta. She has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

If you’ve knocked yourself out to earn a Merit-Based Incentive Payment System (MIPS) bonus payment, it’s pretty safe to say that getting a 1.68% payment boost probably didn’t feel like a “win” that was worth the effort.

And although it saved you from having a negative 5% payment adjustment, many physicians don’t feel that it was worth the effort.

On Jan. 6, the Centers for Medicare & Medicaid Services announced the 2020 payouts for MIPS.

Based on 2018 participation, the bonus for those who scored a perfect 100 is only a 1.68% boost in Medicare reimbursement, slightly lower than last year’s 1.88%. This decline comes as no surprise as the agency leader admits: “As the program matures, we expect that the increases in the performance thresholds in future program years will create a smaller distribution of positive payment adjustments.” Overall, more than 97% of participants avoided having a negative 5% payment adjustment.

Indeed, these bonus monies are based on a short-term appropriation of extra funds from Congress. After these temporary funds are no longer available, there will be little, if any, monies to distribute as the program is based on a “losers-feed-the-winners” construct.

It may be very tempting for many physicians to decide to ignore MIPS, with the rationale that 1.68% is not worth the effort. But don’t let your foot off the gas pedal yet, since the penalty for not participating in 2020 is a substantial 9%. Physicians should make sure that they, at minimum, achieve the 45 points necessary to avoid that pitfall this reporting year.

However, it is certainly time to reconsider efforts to participate at the highest level.
 

Should you or shouldn’t you bother with MIPS?

Let’s say you have $75,000 in revenue from Medicare Part B per year. Depending on the services you offer in your practice, that equates to 500-750 encounters with Medicare beneficiaries per year. (A reminder that MIPS affects only Part B; Medicare Advantage plans do not partake in the program.)

The recent announcement reveals that perfection would equate to an additional $1,260 per year. That’s only if you received the full 100 points; if you were simply an “exceptional performer,” the government will allot an additional $157. That’s less than you get paid for a single office visit.

The difference between perfection and compliance is approximately $1,000. Failure to participate, however, knocks $6,750 off your bottom line. Clearly, that’s a substantial financial loss that would affect most practices. Obviously, the numbers change if you have higher – or lower – Medicare revenue, but it’s important to do the math.

Why? Physicians are spending a significant amount of money to comply with the program requirements. This includes substantial payments to registries – typically $200 to >$1,000 per year – to report the quality measures for the program; electronic health record (EHR) systems, many of which require additional funding for the “upgrade” to a MIPS-compatible system, are also a sizable investment.

These hard costs pale in comparison with the time spent on understanding the ever-changing requirements of the program and the process by which your practice will implement them. Take, for example, something as innocuous as the required “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

You first must understand the elements of the measure: What is a “referral loop?” When do we need to generate one? To whom shall it be sent? What needs to be included in “health information?” What is the electronic address to which we should route the information? How do we obtain that address? Then you must determine how your EHR system captures and reports it.

Only then comes the hard part: How are we going to implement this? That’s only one of more than a dozen required elements: six quality measures, two (to four) improvement activities, and four promoting interoperability requirements. Each one of these elements has a host of requirements, all listed on multipage specification sheets.

The government does not seem to be listening. John Cullen, MD, president of the American Academy of Family Physicians, testified at the Senate Finance Committee in May 2019 that MIPS “has created a burdensome and extremely complex program that has increased practice costs ... ” Yet, later that year, CMS issued another hefty ruling that outlines significant changes to the program, despite the fact that it’s in its fourth performance year.
 

Turning frustration into action

Frustration or even anger may be one reaction, but now is an opportune time to determine your investment in the program. At a minimum, it’s vital to understand and meet the threshold to avoid the penalty. It’s been shifting to date, but it’s now set at 9% for perpetuity.

First, it’s crucial to check on your participation status. CMS revealed that the participation database was recently corrected for so-called inconsistencies, so it pays to double-check. It only takes seconds: Insert your NPI in the QPP Participation Status Tool to determine your eligibility for 2020.

In 2020, the threshold to avoid the penalty is 45 points. To get the 45 points, practices must participate in two improvement activities, which is not difficult as there are 118 options. That will garner 15 points. Then there are 45 points available from the quality category; you need at least 30 to reach the 45-point threshold for penalty avoidance.
 

Smart MIPS hacks that can help you

To obtain the additional 30 points, turn your attention to the quality category. There are 268 quality measures; choose at least six to measure. If you report directly from your EHR system, you’ll get a bonus point for each reported measure, plus one just for trying. (There are a few other opportunities for bonus points, such as improving your scores over last year.) Those bonus points give you a base with which to work, but getting to 45 will require effort to report successfully on at least a couple of the measures.

The quality category has a total of 100 points available, which are converted to 45 toward your composite score. Since you need 30 to reach that magical 45 (if 15 were attained from improvement activities), that means you must come up with 75 points in the quality category. Between the bonus points and measuring a handful of measures successfully through the year, you’ll achieve this threshold.

There are two other categories in the program: promoting interoperability (PI) and cost. The PI category mirrors the old “meaningful use” program; however, it has become increasingly difficult over the years. If you think that you can meet the required elements, you can pick up 25 more points toward your composite score.

Cost is a bit of an unknown, as the scoring is based on a retrospective review of your claims. You’ll likely pick up a few more points on this 15-point category, but there’s no method to determine performance until after the reporting period. Therefore, be cautious about relying on this category.

The best MIPS hack, however, is if you are a small practice. CMS – remarkably – defines a “small practice” as 15 or fewer eligible professionals. If you qualify under this paradigm, you have multiple options to ease compliance:

Apply for a “hardship exemption” simply on the basis of being small; the exemption relates to the promoting operability category, shifting those points to the quality category.

Gain three points per quality measure, regardless of data completeness; this compares to just one point for other physicians.

Capture all of the points available from the Improvement Activities category by confirming participation with just a single activity. (This also applies to all physicians in rural or Health Professional Shortage Areas.)

In the event that you don’t qualify as a “small practice” or you’re still falling short of the requirements, CMS allows for the ultimate “out”: You can apply for exemption on the basis of an “extreme and uncontrollable circumstance.” The applications for these exceptions open this summer.

Unless you qualify for the program exemption, it’s important to keep pace with the program to ensure that you reach the 45-point threshold. It may not, however, be worthwhile to gear up for all 100 points unless your estimate of the potential return – and what it costs you to get there – reveals otherwise. MIPS is not going anywhere; the program is written into the law.

But that doesn’t mean that CMS can’t make tweaks and updates. Hopefully, the revisions won’t create even more administrative burden as the program is quickly turning into a big stick with only a small carrot at the end.

Elizabeth Woodcock is president of Woodcock & Associates in Atlanta. She has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

 What happens to patients at risk for suicide after they leave the emergency department (ED)? According to a new study funded by the National Institute of Mental Health and published in JAMA Network Open, people who presented to California EDs with deliberate self-harm or suicidal ideation were not just at risk for a future suicide—they were at extreme risk.

The researchers divided patients into 3 groups: 83,507 who had deliberately self-harmed with or without co-occurring suicidal ideation; 67,379 presenting with suicidal ideation but without deliberate self-harm; and 497,760 without either self-harm or suicidal ideation.

In the first year after the ED visit, the patients who had presented with deliberate self-harm had a suicide rate almost 57 times higher than that of demographically similar Californians. Among those with suicidal ideation, the suicide rate was about 31 times higher. The suicide rate for the reference group, while the lowest of the 3 groups, was still twice the rate among Californians overall.

The researchers found certain clinical and demographic characteristics predicted subsequent suicide. Men and patients aged > 65 years had higher rates of suicide when compared with women or people aged 10 to 24 years. In all groups, suicide rates were higher for non-Hispanic, white patients.

Comorbid diagnoses were associated with suicide risk but with “striking differences” among the groups, the researchers say. Among patients presenting with deliberate self-harm, those with a comorbid diagnosis of bipolar disorder, anxiety disorder, or a psychotic disorder were more likely to die of suicide. Among reference patients, those with bipolar disorder, depression, or alcohol use disorder had a higher risk.

Of note, the researchers say, patients in the deliberate self-harm group who presented with a firearm-related injury had a subsequent suicide rate of 4.4% in the following year, a far higher rate than that in any other patient group. The researchers urge ED physicians to be aware that patients who present with self-harm who use high-lethality methods at a nonfatal event remain at highly increased risk for future suicide.

To the researchers’ knowledge, this is the first US population-based study to examine 12-month suicide rates after an index ED visit. These findings reinforce the importance of universal screening for suicide risk in EDs and the need for follow-up care, the researchers add, “an approach that has been found to increase the number of ED patients identified as warranting treatment for suicide risk by approximately 2-fold, but which is also not yet widespread.”

 What happens to patients at risk for suicide after they leave the emergency department (ED)? According to a new study funded by the National Institute of Mental Health and published in JAMA Network Open, people who presented to California EDs with deliberate self-harm or suicidal ideation were not just at risk for a future suicide—they were at extreme risk.

The researchers divided patients into 3 groups: 83,507 who had deliberately self-harmed with or without co-occurring suicidal ideation; 67,379 presenting with suicidal ideation but without deliberate self-harm; and 497,760 without either self-harm or suicidal ideation.

In the first year after the ED visit, the patients who had presented with deliberate self-harm had a suicide rate almost 57 times higher than that of demographically similar Californians. Among those with suicidal ideation, the suicide rate was about 31 times higher. The suicide rate for the reference group, while the lowest of the 3 groups, was still twice the rate among Californians overall.

The researchers found certain clinical and demographic characteristics predicted subsequent suicide. Men and patients aged > 65 years had higher rates of suicide when compared with women or people aged 10 to 24 years. In all groups, suicide rates were higher for non-Hispanic, white patients.

Comorbid diagnoses were associated with suicide risk but with “striking differences” among the groups, the researchers say. Among patients presenting with deliberate self-harm, those with a comorbid diagnosis of bipolar disorder, anxiety disorder, or a psychotic disorder were more likely to die of suicide. Among reference patients, those with bipolar disorder, depression, or alcohol use disorder had a higher risk.

Of note, the researchers say, patients in the deliberate self-harm group who presented with a firearm-related injury had a subsequent suicide rate of 4.4% in the following year, a far higher rate than that in any other patient group. The researchers urge ED physicians to be aware that patients who present with self-harm who use high-lethality methods at a nonfatal event remain at highly increased risk for future suicide.

To the researchers’ knowledge, this is the first US population-based study to examine 12-month suicide rates after an index ED visit. These findings reinforce the importance of universal screening for suicide risk in EDs and the need for follow-up care, the researchers add, “an approach that has been found to increase the number of ED patients identified as warranting treatment for suicide risk by approximately 2-fold, but which is also not yet widespread.”

 What happens to patients at risk for suicide after they leave the emergency department (ED)? According to a new study funded by the National Institute of Mental Health and published in JAMA Network Open, people who presented to California EDs with deliberate self-harm or suicidal ideation were not just at risk for a future suicide—they were at extreme risk.

The researchers divided patients into 3 groups: 83,507 who had deliberately self-harmed with or without co-occurring suicidal ideation; 67,379 presenting with suicidal ideation but without deliberate self-harm; and 497,760 without either self-harm or suicidal ideation.

In the first year after the ED visit, the patients who had presented with deliberate self-harm had a suicide rate almost 57 times higher than that of demographically similar Californians. Among those with suicidal ideation, the suicide rate was about 31 times higher. The suicide rate for the reference group, while the lowest of the 3 groups, was still twice the rate among Californians overall.

The researchers found certain clinical and demographic characteristics predicted subsequent suicide. Men and patients aged > 65 years had higher rates of suicide when compared with women or people aged 10 to 24 years. In all groups, suicide rates were higher for non-Hispanic, white patients.

Comorbid diagnoses were associated with suicide risk but with “striking differences” among the groups, the researchers say. Among patients presenting with deliberate self-harm, those with a comorbid diagnosis of bipolar disorder, anxiety disorder, or a psychotic disorder were more likely to die of suicide. Among reference patients, those with bipolar disorder, depression, or alcohol use disorder had a higher risk.

Of note, the researchers say, patients in the deliberate self-harm group who presented with a firearm-related injury had a subsequent suicide rate of 4.4% in the following year, a far higher rate than that in any other patient group. The researchers urge ED physicians to be aware that patients who present with self-harm who use high-lethality methods at a nonfatal event remain at highly increased risk for future suicide.

To the researchers’ knowledge, this is the first US population-based study to examine 12-month suicide rates after an index ED visit. These findings reinforce the importance of universal screening for suicide risk in EDs and the need for follow-up care, the researchers add, “an approach that has been found to increase the number of ED patients identified as warranting treatment for suicide risk by approximately 2-fold, but which is also not yet widespread.”

A total of 165 persons in the United States are under investigation for infection with the 2019 Novel Coronavirus (2019-nCoV), with 68 testing negative and only 5 confirming positive, according to data presented Jan. 29 during a Centers for Disease Control and Prevention (CDC) briefing. 

The remaining samples are in transit or are being processed at the CDC for testing, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the briefing.

“The genetic sequence for all five viruses detected in the United States to date has been uploaded to the CDC website,” she said. “We are working quickly through the process to get the CDC-developed test into the hands of public health partners in the U.S. and internationally.”

Dr. Messonnier reported that the CDC is expanding screening efforts to U.S. ports of entry that house CDC quarantine stations. Also, in collaboration with U.S. Customs and Border Protection, the agency is expanding distribution of travel health education materials to all travelers from China.

“The good news here is that, despite an aggressive public health investigation to find new cases [of 2019-nCoV], we have not,” she said. “The situation in China is concerning, however, we are looking hard here in the U.S. We will continue to be proactive. I still expect that we will find additional cases.”

In another development, the federal government facilitated the return of a plane full of U.S. citizens living in Wuhan, China, to March Air Reserve Force Base in Riverside County, Calif. “We have taken every precaution to ensure their safety while also continuing to protect the health of our nation and the people around them,” Dr. Messonnier said.

All 195 passengers have been screened, monitored, and evaluated by medical personnel “every step of the way,” including before takeoff, during the flight, during a refueling stop in Alaska, and again upon landing at March Air Reserve Force Base on Jan. 28. “All 195 patients are without the symptoms of the novel coronavirus, and all have been assigned living quarters at the Air Force base,” Dr. Messonnier said.

The CDC has launched a second stage of further screening and information gathering from the passengers, who will be offered testing as part of a thorough risk assessment.

“I understand that many people in the U.S. are worried about this virus and whether it will affect them,” Dr. Messonnier said. “Outbreaks like this are always concerning, particularly when a new virus is emerging. But we are well prepared and working closely with federal, state, and local partners to protect our communities and others nationwide from this public health threat. At this time, we continue to believe that the immediate health risk from this new virus to the general American public is low.”

dbrunk@mdedge.com

A total of 165 persons in the United States are under investigation for infection with the 2019 Novel Coronavirus (2019-nCoV), with 68 testing negative and only 5 confirming positive, according to data presented Jan. 29 during a Centers for Disease Control and Prevention (CDC) briefing. 

The remaining samples are in transit or are being processed at the CDC for testing, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the briefing.

“The genetic sequence for all five viruses detected in the United States to date has been uploaded to the CDC website,” she said. “We are working quickly through the process to get the CDC-developed test into the hands of public health partners in the U.S. and internationally.”

Dr. Messonnier reported that the CDC is expanding screening efforts to U.S. ports of entry that house CDC quarantine stations. Also, in collaboration with U.S. Customs and Border Protection, the agency is expanding distribution of travel health education materials to all travelers from China.

“The good news here is that, despite an aggressive public health investigation to find new cases [of 2019-nCoV], we have not,” she said. “The situation in China is concerning, however, we are looking hard here in the U.S. We will continue to be proactive. I still expect that we will find additional cases.”

In another development, the federal government facilitated the return of a plane full of U.S. citizens living in Wuhan, China, to March Air Reserve Force Base in Riverside County, Calif. “We have taken every precaution to ensure their safety while also continuing to protect the health of our nation and the people around them,” Dr. Messonnier said.

All 195 passengers have been screened, monitored, and evaluated by medical personnel “every step of the way,” including before takeoff, during the flight, during a refueling stop in Alaska, and again upon landing at March Air Reserve Force Base on Jan. 28. “All 195 patients are without the symptoms of the novel coronavirus, and all have been assigned living quarters at the Air Force base,” Dr. Messonnier said.

The CDC has launched a second stage of further screening and information gathering from the passengers, who will be offered testing as part of a thorough risk assessment.

“I understand that many people in the U.S. are worried about this virus and whether it will affect them,” Dr. Messonnier said. “Outbreaks like this are always concerning, particularly when a new virus is emerging. But we are well prepared and working closely with federal, state, and local partners to protect our communities and others nationwide from this public health threat. At this time, we continue to believe that the immediate health risk from this new virus to the general American public is low.”

dbrunk@mdedge.com

A total of 165 persons in the United States are under investigation for infection with the 2019 Novel Coronavirus (2019-nCoV), with 68 testing negative and only 5 confirming positive, according to data presented Jan. 29 during a Centers for Disease Control and Prevention (CDC) briefing. 

The remaining samples are in transit or are being processed at the CDC for testing, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the briefing.

“The genetic sequence for all five viruses detected in the United States to date has been uploaded to the CDC website,” she said. “We are working quickly through the process to get the CDC-developed test into the hands of public health partners in the U.S. and internationally.”

Dr. Messonnier reported that the CDC is expanding screening efforts to U.S. ports of entry that house CDC quarantine stations. Also, in collaboration with U.S. Customs and Border Protection, the agency is expanding distribution of travel health education materials to all travelers from China.

“The good news here is that, despite an aggressive public health investigation to find new cases [of 2019-nCoV], we have not,” she said. “The situation in China is concerning, however, we are looking hard here in the U.S. We will continue to be proactive. I still expect that we will find additional cases.”

In another development, the federal government facilitated the return of a plane full of U.S. citizens living in Wuhan, China, to March Air Reserve Force Base in Riverside County, Calif. “We have taken every precaution to ensure their safety while also continuing to protect the health of our nation and the people around them,” Dr. Messonnier said.

All 195 passengers have been screened, monitored, and evaluated by medical personnel “every step of the way,” including before takeoff, during the flight, during a refueling stop in Alaska, and again upon landing at March Air Reserve Force Base on Jan. 28. “All 195 patients are without the symptoms of the novel coronavirus, and all have been assigned living quarters at the Air Force base,” Dr. Messonnier said.

The CDC has launched a second stage of further screening and information gathering from the passengers, who will be offered testing as part of a thorough risk assessment.

“I understand that many people in the U.S. are worried about this virus and whether it will affect them,” Dr. Messonnier said. “Outbreaks like this are always concerning, particularly when a new virus is emerging. But we are well prepared and working closely with federal, state, and local partners to protect our communities and others nationwide from this public health threat. At this time, we continue to believe that the immediate health risk from this new virus to the general American public is low.”

dbrunk@mdedge.com

A biopsy of the skin was consistent with folliculitis, but a dental panoramic x-ray revealed an abscess of tooth number 30, which is on the right side. This combination of findings was consistent with a dental sinus.

This unusual diagnosis is most common in adults and arises from dental disease in the mid mandibular pre-molars. It will appear as an abscess or crusted papule and can occur in the lower jaw, neck, or occasionally, the mid cheek. Children are rarely affected. Because the sinus opening relieves pressure from the dental abscess, there is often little to no pain.

It can be challenging to convince a patient that his or her skin lesion derives from dental disease. Often, though, patients are glad it is not cancer. Patients should be referred to an endodontist for a work-up and a root canal, which is the preferred treatment. If a root canal is not feasible, dental extraction will lead to cure.

In this case, the patient promptly underwent a root canal and was cured in 2 weeks. The scar from the papule can have a depressed appearance (FIGURE 2), which can be addressed with excisional scar revision once the underlying abscess is cured.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A biopsy of the skin was consistent with folliculitis, but a dental panoramic x-ray revealed an abscess of tooth number 30, which is on the right side. This combination of findings was consistent with a dental sinus.

This unusual diagnosis is most common in adults and arises from dental disease in the mid mandibular pre-molars. It will appear as an abscess or crusted papule and can occur in the lower jaw, neck, or occasionally, the mid cheek. Children are rarely affected. Because the sinus opening relieves pressure from the dental abscess, there is often little to no pain.

It can be challenging to convince a patient that his or her skin lesion derives from dental disease. Often, though, patients are glad it is not cancer. Patients should be referred to an endodontist for a work-up and a root canal, which is the preferred treatment. If a root canal is not feasible, dental extraction will lead to cure.

In this case, the patient promptly underwent a root canal and was cured in 2 weeks. The scar from the papule can have a depressed appearance (FIGURE 2), which can be addressed with excisional scar revision once the underlying abscess is cured.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A biopsy of the skin was consistent with folliculitis, but a dental panoramic x-ray revealed an abscess of tooth number 30, which is on the right side. This combination of findings was consistent with a dental sinus.

This unusual diagnosis is most common in adults and arises from dental disease in the mid mandibular pre-molars. It will appear as an abscess or crusted papule and can occur in the lower jaw, neck, or occasionally, the mid cheek. Children are rarely affected. Because the sinus opening relieves pressure from the dental abscess, there is often little to no pain.

It can be challenging to convince a patient that his or her skin lesion derives from dental disease. Often, though, patients are glad it is not cancer. Patients should be referred to an endodontist for a work-up and a root canal, which is the preferred treatment. If a root canal is not feasible, dental extraction will lead to cure.

In this case, the patient promptly underwent a root canal and was cured in 2 weeks. The scar from the papule can have a depressed appearance (FIGURE 2), which can be addressed with excisional scar revision once the underlying abscess is cured.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

The cost of health care is keeping more Americans from seeing a doctor, even as the number of individuals with insurance coverage increases, according to a new study.

“Despite short-term gains owing to the [Affordable Care Act], over the past 20 years the portion of adults aged 18-64 years unable to see a physician owing to the cost increased, mostly because of an increase among persons with insurance,” Laura Hawks, MD, of Cambridge (Mass.) Health Alliance and Harvard Medical School in Boston and colleagues wrote in a new research report published in JAMA Internal Medicine.

“In 2017, nearly one-fifth of individuals with any chronic condition (diabetes, obesity, or cardiovascular disease) said they were unable to see a physician owing to cost,” they continued.

Researchers examined 20 years of data (January 1998 through December 2017) from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System to identify trends in unmet need for physician and preventive services.

Among adults aged 18-64 years who responded to the survey in 1998 and 2017, uninsurance decreased by 2.1 percentage points, falling from 16.9% to 14.8%. But at the same time, the portion of adults who were unable to see a physician because of cost rose by 2.7 percentage points, from 11.4% to 15.7%. Looking specifically at adults who had insurance coverage, the researchers found that cost was a barrier for 11.5% of them in 2017, up from 7.1% in 1998.

These results come against a backdrop of growing medical costs, increasing deductibles and copayments, an increasing use of cost containment measures like prior authorization, and narrow provider networks in the wake of the transition to value-based payment structures, the authors noted.

“Our finding that financial access to physician care worsened is concerning,” Dr. Hawks and her colleagues wrote. “Persons with conditions such as diabetes, hypertension, cardiovascular disease, and poor health status risk substantial harms if they forgo physician care. Financial barriers to care have been associated with increased hospitalizations and worse health outcomes in patients with cardiovascular disease and hypertension and increased morbidity among patients with diabetes.”

One of the trends highlighted by the study authors is the growing number of employers offering plans with a high deductible.

“Enrollment in a high-deductible health plan, which has become increasingly common in the last decade, a trend uninterrupted by the ACA, is associated with forgoing needed care, especially among those of lower socioeconomic status,” the authors wrote. “Other changes in insurance benefit design, such as imposing tiered copayments and coinsurance obligations, eliminating coverage for some services (e.g., eyeglasses) and narrowing provider networks (which can force some patients to go out-of-network for care) may also have undermined the affordability of care.”

There was some positive news among the findings, however.

“The main encouraging finding from our analysis is the increase in the proportion of persons – both insured and uninsured – receiving cholesterol checks and flu shots,” Dr. Hawk and her colleagues wrote, adding that this increase “may be attributable to the increasing implementation of quality metrics, financial incentives, and improved systems for the delivery of these services.”

However, not all preventive services that had cost barriers eliminated under the ACA saw improvement, such as cancer screening. They note that the proportion of women who did not receive mammography increased during the study period and then plateaued, but did not improve following the implementation of the ACA. The authors described the reasons for this as “unclear.”

Dr. Hawks received funding support from an Institutional National Research Service award and from Cambridge Health Alliance, her employer. Other authors reported membership in Physicians for a National Health Program.

gtwachtman@mdedge.com

SOURCE: Hawks L et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6538.

The cost of health care is keeping more Americans from seeing a doctor, even as the number of individuals with insurance coverage increases, according to a new study.

“Despite short-term gains owing to the [Affordable Care Act], over the past 20 years the portion of adults aged 18-64 years unable to see a physician owing to the cost increased, mostly because of an increase among persons with insurance,” Laura Hawks, MD, of Cambridge (Mass.) Health Alliance and Harvard Medical School in Boston and colleagues wrote in a new research report published in JAMA Internal Medicine.

“In 2017, nearly one-fifth of individuals with any chronic condition (diabetes, obesity, or cardiovascular disease) said they were unable to see a physician owing to cost,” they continued.

Researchers examined 20 years of data (January 1998 through December 2017) from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System to identify trends in unmet need for physician and preventive services.

Among adults aged 18-64 years who responded to the survey in 1998 and 2017, uninsurance decreased by 2.1 percentage points, falling from 16.9% to 14.8%. But at the same time, the portion of adults who were unable to see a physician because of cost rose by 2.7 percentage points, from 11.4% to 15.7%. Looking specifically at adults who had insurance coverage, the researchers found that cost was a barrier for 11.5% of them in 2017, up from 7.1% in 1998.

These results come against a backdrop of growing medical costs, increasing deductibles and copayments, an increasing use of cost containment measures like prior authorization, and narrow provider networks in the wake of the transition to value-based payment structures, the authors noted.

“Our finding that financial access to physician care worsened is concerning,” Dr. Hawks and her colleagues wrote. “Persons with conditions such as diabetes, hypertension, cardiovascular disease, and poor health status risk substantial harms if they forgo physician care. Financial barriers to care have been associated with increased hospitalizations and worse health outcomes in patients with cardiovascular disease and hypertension and increased morbidity among patients with diabetes.”

One of the trends highlighted by the study authors is the growing number of employers offering plans with a high deductible.

“Enrollment in a high-deductible health plan, which has become increasingly common in the last decade, a trend uninterrupted by the ACA, is associated with forgoing needed care, especially among those of lower socioeconomic status,” the authors wrote. “Other changes in insurance benefit design, such as imposing tiered copayments and coinsurance obligations, eliminating coverage for some services (e.g., eyeglasses) and narrowing provider networks (which can force some patients to go out-of-network for care) may also have undermined the affordability of care.”

There was some positive news among the findings, however.

“The main encouraging finding from our analysis is the increase in the proportion of persons – both insured and uninsured – receiving cholesterol checks and flu shots,” Dr. Hawk and her colleagues wrote, adding that this increase “may be attributable to the increasing implementation of quality metrics, financial incentives, and improved systems for the delivery of these services.”

However, not all preventive services that had cost barriers eliminated under the ACA saw improvement, such as cancer screening. They note that the proportion of women who did not receive mammography increased during the study period and then plateaued, but did not improve following the implementation of the ACA. The authors described the reasons for this as “unclear.”

Dr. Hawks received funding support from an Institutional National Research Service award and from Cambridge Health Alliance, her employer. Other authors reported membership in Physicians for a National Health Program.

gtwachtman@mdedge.com

SOURCE: Hawks L et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6538.

The cost of health care is keeping more Americans from seeing a doctor, even as the number of individuals with insurance coverage increases, according to a new study.

“Despite short-term gains owing to the [Affordable Care Act], over the past 20 years the portion of adults aged 18-64 years unable to see a physician owing to the cost increased, mostly because of an increase among persons with insurance,” Laura Hawks, MD, of Cambridge (Mass.) Health Alliance and Harvard Medical School in Boston and colleagues wrote in a new research report published in JAMA Internal Medicine.

“In 2017, nearly one-fifth of individuals with any chronic condition (diabetes, obesity, or cardiovascular disease) said they were unable to see a physician owing to cost,” they continued.

Researchers examined 20 years of data (January 1998 through December 2017) from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System to identify trends in unmet need for physician and preventive services.

Among adults aged 18-64 years who responded to the survey in 1998 and 2017, uninsurance decreased by 2.1 percentage points, falling from 16.9% to 14.8%. But at the same time, the portion of adults who were unable to see a physician because of cost rose by 2.7 percentage points, from 11.4% to 15.7%. Looking specifically at adults who had insurance coverage, the researchers found that cost was a barrier for 11.5% of them in 2017, up from 7.1% in 1998.

These results come against a backdrop of growing medical costs, increasing deductibles and copayments, an increasing use of cost containment measures like prior authorization, and narrow provider networks in the wake of the transition to value-based payment structures, the authors noted.

“Our finding that financial access to physician care worsened is concerning,” Dr. Hawks and her colleagues wrote. “Persons with conditions such as diabetes, hypertension, cardiovascular disease, and poor health status risk substantial harms if they forgo physician care. Financial barriers to care have been associated with increased hospitalizations and worse health outcomes in patients with cardiovascular disease and hypertension and increased morbidity among patients with diabetes.”

One of the trends highlighted by the study authors is the growing number of employers offering plans with a high deductible.

“Enrollment in a high-deductible health plan, which has become increasingly common in the last decade, a trend uninterrupted by the ACA, is associated with forgoing needed care, especially among those of lower socioeconomic status,” the authors wrote. “Other changes in insurance benefit design, such as imposing tiered copayments and coinsurance obligations, eliminating coverage for some services (e.g., eyeglasses) and narrowing provider networks (which can force some patients to go out-of-network for care) may also have undermined the affordability of care.”

There was some positive news among the findings, however.

“The main encouraging finding from our analysis is the increase in the proportion of persons – both insured and uninsured – receiving cholesterol checks and flu shots,” Dr. Hawk and her colleagues wrote, adding that this increase “may be attributable to the increasing implementation of quality metrics, financial incentives, and improved systems for the delivery of these services.”

However, not all preventive services that had cost barriers eliminated under the ACA saw improvement, such as cancer screening. They note that the proportion of women who did not receive mammography increased during the study period and then plateaued, but did not improve following the implementation of the ACA. The authors described the reasons for this as “unclear.”

Dr. Hawks received funding support from an Institutional National Research Service award and from Cambridge Health Alliance, her employer. Other authors reported membership in Physicians for a National Health Program.

gtwachtman@mdedge.com

SOURCE: Hawks L et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6538.

CT scan screening of older people with heavy smoking histories – using lesion volume, not diameter, as a trigger for further work-up – reduced lung cancer deaths by about 30% in a randomized trial from the Netherlands and Belgium with almost 16,000 current and former smokers, investigators reported in the New England Journal of Medicine.

The Dutch-Belgian lung-cancer screening trial (Nederlands-Leuvens Longkanker Screenings Onderzoek [NELSON]) is “arguably the only adequately powered trial other than the” National Lung Screening Trial (NLST) in the United States to assess the role of CT scan screening among smokers, wrote University of London cancer epidemiologist Stephen Duffy, MSc, and University of Liverpool molecular oncology professor John Field, PhD, in an accompanying editorial.

NLST, which used lesion diameter, found an approximately 20% lower lung cancer mortality than screening with chest x-rays among 53,454 heavy smokers after a median follow-up of 6.5 years. The trial ultimately led the U.S. Preventive Services Task Force to recommend annual screening for people aged 55-80 years with a history of at least 30 pack-years.

European countries have considered similar programs but have hesitated “partly due to doubts fostered by the early publication of inconclusive results of a number of smaller trials in Europe. These doubts should be laid to rest,” Mr. Duffy and Dr. Field wrote.

“With the NELSON results, the efficacy of low-dose CT screening for lung cancer is confirmed. Our job is no longer to assess whether low-dose CT screening for lung cancer works; it does. Our job is to identify the target population in which it will be acceptable and cost effective,” they added.

The 15,789 NELSON participants (84% men, with a median age of 58 years and 38 pack-year history) were randomized about 1:1 to either low-dose CT scan screening at baseline and 1, 3, and 5.5 years, or to no screening.

At 10 years follow-up, there were 5.58 lung cancer cases and 2.5 deaths per 1,000 person-years in the screened group versus 4.91 cases and 3.3 deaths per 1,000 person-years among controls. Lung-cancer mortality was 24% lower among screened subjects overall, and 33% lower among screened women. The team estimated that screening prevented about 60 lung cancer deaths.

Using volume instead of diameter “resulted in low[er] referral rates” – 2.1% with a positive predictive value of 43.5% versus 24% with a positive predictive value of 3.8% in NLST – for additional work-up, explained investigators led by H.J. de Koning, MD, PhD, of the department of public health at Erasmus University Medical Center in Rotterdam, the Netherlands.

The upper limit of overdiagnosis risk – a major concern with any screening program – was 18.5% with NLST versus 8.9% with NELSON, they wrote.

In short: “Volume CT screening enabled a significant reduction of harms (e.g., false positive tests and unnecessary work-up procedures) without jeopardizing favorable outcomes,” the investigators wrote. Indeed, an ad hoc analysis suggested “more-favorable effects on lung-cancer mortality than in the NLST, despite lower referral rates for suspicious lesions” and the fact that NLST used annual screening.

“Recently,” Mr. Duffy and Dr. Field explained in their editorial, “the NELSON investigators evaluated both diameter and volume measurement to estimate lung-nodule size as an imaging biomarker for nodule management; this provided evidence that using mean or maximum axial diameter to assess nodule volume led to a substantial overestimation of nodule volume.” Direct measurement of volume “resulted in a substantial number of early-stage cancers identified at the time of diagnosis and avoided false positives from the overestimation incurred by management based on diameter.”

“The lung-nodule management system used in the NELSON trial has been advocated in the European position statement on lung-cancer screening. This will improve the acceptability of the intervention, because the rate of further investigation has been a major concern in lung cancer screening,” they wrote.

Baseline characteristics did not differ significantly between the screened and unscreened in NELSON, except for a slightly longer duration of smoking in the screened group.

The work was funded by the Netherlands Organization of Health Research and Development, among others. Mr. Duffy and Dr. de Koning didn’t report any disclosures. Dr. Field is an advisor for AstraZeneca, Epigenomics, and Nucleix, and has a research grant to his university from Janssen.
 

SOURCE: de Honing HJ et al. N Engl J Med. 2020 Jan 29. doi: 10.1056/NEJMoa1911793.

CT scan screening of older people with heavy smoking histories – using lesion volume, not diameter, as a trigger for further work-up – reduced lung cancer deaths by about 30% in a randomized trial from the Netherlands and Belgium with almost 16,000 current and former smokers, investigators reported in the New England Journal of Medicine.

The Dutch-Belgian lung-cancer screening trial (Nederlands-Leuvens Longkanker Screenings Onderzoek [NELSON]) is “arguably the only adequately powered trial other than the” National Lung Screening Trial (NLST) in the United States to assess the role of CT scan screening among smokers, wrote University of London cancer epidemiologist Stephen Duffy, MSc, and University of Liverpool molecular oncology professor John Field, PhD, in an accompanying editorial.

NLST, which used lesion diameter, found an approximately 20% lower lung cancer mortality than screening with chest x-rays among 53,454 heavy smokers after a median follow-up of 6.5 years. The trial ultimately led the U.S. Preventive Services Task Force to recommend annual screening for people aged 55-80 years with a history of at least 30 pack-years.

European countries have considered similar programs but have hesitated “partly due to doubts fostered by the early publication of inconclusive results of a number of smaller trials in Europe. These doubts should be laid to rest,” Mr. Duffy and Dr. Field wrote.

“With the NELSON results, the efficacy of low-dose CT screening for lung cancer is confirmed. Our job is no longer to assess whether low-dose CT screening for lung cancer works; it does. Our job is to identify the target population in which it will be acceptable and cost effective,” they added.

The 15,789 NELSON participants (84% men, with a median age of 58 years and 38 pack-year history) were randomized about 1:1 to either low-dose CT scan screening at baseline and 1, 3, and 5.5 years, or to no screening.

At 10 years follow-up, there were 5.58 lung cancer cases and 2.5 deaths per 1,000 person-years in the screened group versus 4.91 cases and 3.3 deaths per 1,000 person-years among controls. Lung-cancer mortality was 24% lower among screened subjects overall, and 33% lower among screened women. The team estimated that screening prevented about 60 lung cancer deaths.

Using volume instead of diameter “resulted in low[er] referral rates” – 2.1% with a positive predictive value of 43.5% versus 24% with a positive predictive value of 3.8% in NLST – for additional work-up, explained investigators led by H.J. de Koning, MD, PhD, of the department of public health at Erasmus University Medical Center in Rotterdam, the Netherlands.

The upper limit of overdiagnosis risk – a major concern with any screening program – was 18.5% with NLST versus 8.9% with NELSON, they wrote.

In short: “Volume CT screening enabled a significant reduction of harms (e.g., false positive tests and unnecessary work-up procedures) without jeopardizing favorable outcomes,” the investigators wrote. Indeed, an ad hoc analysis suggested “more-favorable effects on lung-cancer mortality than in the NLST, despite lower referral rates for suspicious lesions” and the fact that NLST used annual screening.

“Recently,” Mr. Duffy and Dr. Field explained in their editorial, “the NELSON investigators evaluated both diameter and volume measurement to estimate lung-nodule size as an imaging biomarker for nodule management; this provided evidence that using mean or maximum axial diameter to assess nodule volume led to a substantial overestimation of nodule volume.” Direct measurement of volume “resulted in a substantial number of early-stage cancers identified at the time of diagnosis and avoided false positives from the overestimation incurred by management based on diameter.”

“The lung-nodule management system used in the NELSON trial has been advocated in the European position statement on lung-cancer screening. This will improve the acceptability of the intervention, because the rate of further investigation has been a major concern in lung cancer screening,” they wrote.

Baseline characteristics did not differ significantly between the screened and unscreened in NELSON, except for a slightly longer duration of smoking in the screened group.

The work was funded by the Netherlands Organization of Health Research and Development, among others. Mr. Duffy and Dr. de Koning didn’t report any disclosures. Dr. Field is an advisor for AstraZeneca, Epigenomics, and Nucleix, and has a research grant to his university from Janssen.
 

SOURCE: de Honing HJ et al. N Engl J Med. 2020 Jan 29. doi: 10.1056/NEJMoa1911793.

CT scan screening of older people with heavy smoking histories – using lesion volume, not diameter, as a trigger for further work-up – reduced lung cancer deaths by about 30% in a randomized trial from the Netherlands and Belgium with almost 16,000 current and former smokers, investigators reported in the New England Journal of Medicine.

The Dutch-Belgian lung-cancer screening trial (Nederlands-Leuvens Longkanker Screenings Onderzoek [NELSON]) is “arguably the only adequately powered trial other than the” National Lung Screening Trial (NLST) in the United States to assess the role of CT scan screening among smokers, wrote University of London cancer epidemiologist Stephen Duffy, MSc, and University of Liverpool molecular oncology professor John Field, PhD, in an accompanying editorial.

NLST, which used lesion diameter, found an approximately 20% lower lung cancer mortality than screening with chest x-rays among 53,454 heavy smokers after a median follow-up of 6.5 years. The trial ultimately led the U.S. Preventive Services Task Force to recommend annual screening for people aged 55-80 years with a history of at least 30 pack-years.

European countries have considered similar programs but have hesitated “partly due to doubts fostered by the early publication of inconclusive results of a number of smaller trials in Europe. These doubts should be laid to rest,” Mr. Duffy and Dr. Field wrote.

“With the NELSON results, the efficacy of low-dose CT screening for lung cancer is confirmed. Our job is no longer to assess whether low-dose CT screening for lung cancer works; it does. Our job is to identify the target population in which it will be acceptable and cost effective,” they added.

The 15,789 NELSON participants (84% men, with a median age of 58 years and 38 pack-year history) were randomized about 1:1 to either low-dose CT scan screening at baseline and 1, 3, and 5.5 years, or to no screening.

At 10 years follow-up, there were 5.58 lung cancer cases and 2.5 deaths per 1,000 person-years in the screened group versus 4.91 cases and 3.3 deaths per 1,000 person-years among controls. Lung-cancer mortality was 24% lower among screened subjects overall, and 33% lower among screened women. The team estimated that screening prevented about 60 lung cancer deaths.

Using volume instead of diameter “resulted in low[er] referral rates” – 2.1% with a positive predictive value of 43.5% versus 24% with a positive predictive value of 3.8% in NLST – for additional work-up, explained investigators led by H.J. de Koning, MD, PhD, of the department of public health at Erasmus University Medical Center in Rotterdam, the Netherlands.

The upper limit of overdiagnosis risk – a major concern with any screening program – was 18.5% with NLST versus 8.9% with NELSON, they wrote.

In short: “Volume CT screening enabled a significant reduction of harms (e.g., false positive tests and unnecessary work-up procedures) without jeopardizing favorable outcomes,” the investigators wrote. Indeed, an ad hoc analysis suggested “more-favorable effects on lung-cancer mortality than in the NLST, despite lower referral rates for suspicious lesions” and the fact that NLST used annual screening.

“Recently,” Mr. Duffy and Dr. Field explained in their editorial, “the NELSON investigators evaluated both diameter and volume measurement to estimate lung-nodule size as an imaging biomarker for nodule management; this provided evidence that using mean or maximum axial diameter to assess nodule volume led to a substantial overestimation of nodule volume.” Direct measurement of volume “resulted in a substantial number of early-stage cancers identified at the time of diagnosis and avoided false positives from the overestimation incurred by management based on diameter.”

“The lung-nodule management system used in the NELSON trial has been advocated in the European position statement on lung-cancer screening. This will improve the acceptability of the intervention, because the rate of further investigation has been a major concern in lung cancer screening,” they wrote.

Baseline characteristics did not differ significantly between the screened and unscreened in NELSON, except for a slightly longer duration of smoking in the screened group.

The work was funded by the Netherlands Organization of Health Research and Development, among others. Mr. Duffy and Dr. de Koning didn’t report any disclosures. Dr. Field is an advisor for AstraZeneca, Epigenomics, and Nucleix, and has a research grant to his university from Janssen.
 

SOURCE: de Honing HJ et al. N Engl J Med. 2020 Jan 29. doi: 10.1056/NEJMoa1911793.

If I only had a nose

PeopleImages/E+

Deaf and blind people get all the attention. Special schools, Braille, sign language, even a pinball-focused rock opera. And it is easy to see why: Those senses are kind of important when it comes to navigating the world. But what if you have to live without one of the less-cool senses? What if the nose doesn’t know?

According to research published in Clinical Otolaryngology, up to 5% of the world’s population has some sort of smell disorder, preventing them from either smelling correctly or smelling anything at all. And the effects of this on everyday life are drastic.

In a survey of 71 people with smell disorders, the researchers found that patients experience a smorgasbord of negative effects – ranging from poor hazard perception and poor sense of personal hygiene, to an inability to enjoy food and an inability to link smell to happy memories. The whiff of gingerbread on Christmas morning, the smoke of a bonfire on a summer evening – the smell-deprived miss out on them all. The negative emotions those people experience read like a recipe for your very own homemade Sith lord: sadness, regret, isolation, anxiety, anger, frustration. A path to the dark side, losing your scent is.

Speaking of fictional bad guys, this nasal-based research really could have benefited one Lord Volde ... fine, You-Know-Who. Just look at that face. That’s a man who can’t smell. You can’t tell us he wouldn’t have turned out better if only Dorothy had picked him up on the yellow brick road instead of some dumb scarecrow.
 

The sound of hieroglyphics

stigalenas/iStock/Getty Images Plus

The Rosetta Stone revealed the meaning of Egyptian hieroglyphics and unlocked the ancient language of the Pharaohs for modern humans. But that mute stele said nothing about what those who uttered that ancient tongue sounded like.

Researchers at London’s Royal Holloway College may now know the answer. At least, a monosyllabic one.

The answer comes (indirectly) from Egyptian priest Nesyamun, a former resident of Thebes who worked at the temple of Karnak, but who now calls the Leeds City Museum home. Or, to be precise, Nesyamun’s 3,000-year-old mummified remains live on in Leeds. Nesyamun’s religious duties during his Karnak career likely required a smooth singing style and an accomplished speaking voice.

In a paper published in Scientific Reports, the British scientists say they’ve now heard the sound of the Egyptian priest’s long-silenced liturgical voice.

Working from CT scans of Nesyamun’s relatively well-preserved vocal-tract soft tissue, the scientists used a 3D-printed vocal tract and an electronic larynx to synthesize the actual sound of his voice.

And the result? Did the crooning priest of Karnak utter a Boris Karloffian curse upon those who had disturbed his millennia-long slumber? Did he deliver a rousing hymn of praise to Egypt’s ruler during the turbulent 1070s bce, Ramses XI?

In fact, what emerged from Nesyamun’s synthesized throat was ... “eh.” Maybe “a,” as in “bad.”

Given the state of the priest’s tongue (shrunken) and his soft palate (missing), the researchers say those monosyllabic sounds are the best Nesyamun can muster in his present state. Other experts say actual words from the ancients are likely impossible.

Perhaps one day, science will indeed be able to synthesize whole words or sentences from other well-preserved residents of the distant past. May we all live to hear an unyielding Ramses II himself chew the scenery like his Hollywood doppelganger, Yul Brynner: “So let it be written! So let it be done!”
 

To beard or not to beard

RyanJLane/E+

People are funny, and men, who happen to be people, are no exception.

Men, you see, have these things called beards, and there are definitely more men running around with facial hair these days. A lot of women go through a lot of trouble to get rid of a lot of their hair. But men, well, we grow extra hair. Why?

That’s what Honest Amish, a maker of beard-care products, wanted to know. They commissioned OnePoll to conduct a survey of 2,000 Americans, both men and women, to learn all kinds of things about beards.

So what did they find? Facial hair confidence, that’s what. Three-quarters of men said that a beard made them feel more confident than did a bare face, and 73% said that facial hair makes a man more attractive. That number was a bit lower among women, 63% of whom said that facial hair made a man more attractive.

That doesn’t seem very funny, does it? We’re getting there.

Male respondents also were asked what they would do to get the perfect beard: 40% would be willing to spend a night in jail or give up coffee for a year, and 38% would stand in line at the DMV for an entire day. Somewhat less popular responses included giving up sex for a year (22%) – seems like a waste of all that new-found confidence – and shaving their heads (18%).

And that, we don’t mind saying, is a hair-raising conclusion.




 

If I only had a nose

PeopleImages/E+

Deaf and blind people get all the attention. Special schools, Braille, sign language, even a pinball-focused rock opera. And it is easy to see why: Those senses are kind of important when it comes to navigating the world. But what if you have to live without one of the less-cool senses? What if the nose doesn’t know?

According to research published in Clinical Otolaryngology, up to 5% of the world’s population has some sort of smell disorder, preventing them from either smelling correctly or smelling anything at all. And the effects of this on everyday life are drastic.

In a survey of 71 people with smell disorders, the researchers found that patients experience a smorgasbord of negative effects – ranging from poor hazard perception and poor sense of personal hygiene, to an inability to enjoy food and an inability to link smell to happy memories. The whiff of gingerbread on Christmas morning, the smoke of a bonfire on a summer evening – the smell-deprived miss out on them all. The negative emotions those people experience read like a recipe for your very own homemade Sith lord: sadness, regret, isolation, anxiety, anger, frustration. A path to the dark side, losing your scent is.

Speaking of fictional bad guys, this nasal-based research really could have benefited one Lord Volde ... fine, You-Know-Who. Just look at that face. That’s a man who can’t smell. You can’t tell us he wouldn’t have turned out better if only Dorothy had picked him up on the yellow brick road instead of some dumb scarecrow.
 

The sound of hieroglyphics

stigalenas/iStock/Getty Images Plus

The Rosetta Stone revealed the meaning of Egyptian hieroglyphics and unlocked the ancient language of the Pharaohs for modern humans. But that mute stele said nothing about what those who uttered that ancient tongue sounded like.

Researchers at London’s Royal Holloway College may now know the answer. At least, a monosyllabic one.

The answer comes (indirectly) from Egyptian priest Nesyamun, a former resident of Thebes who worked at the temple of Karnak, but who now calls the Leeds City Museum home. Or, to be precise, Nesyamun’s 3,000-year-old mummified remains live on in Leeds. Nesyamun’s religious duties during his Karnak career likely required a smooth singing style and an accomplished speaking voice.

In a paper published in Scientific Reports, the British scientists say they’ve now heard the sound of the Egyptian priest’s long-silenced liturgical voice.

Working from CT scans of Nesyamun’s relatively well-preserved vocal-tract soft tissue, the scientists used a 3D-printed vocal tract and an electronic larynx to synthesize the actual sound of his voice.

And the result? Did the crooning priest of Karnak utter a Boris Karloffian curse upon those who had disturbed his millennia-long slumber? Did he deliver a rousing hymn of praise to Egypt’s ruler during the turbulent 1070s bce, Ramses XI?

In fact, what emerged from Nesyamun’s synthesized throat was ... “eh.” Maybe “a,” as in “bad.”

Given the state of the priest’s tongue (shrunken) and his soft palate (missing), the researchers say those monosyllabic sounds are the best Nesyamun can muster in his present state. Other experts say actual words from the ancients are likely impossible.

Perhaps one day, science will indeed be able to synthesize whole words or sentences from other well-preserved residents of the distant past. May we all live to hear an unyielding Ramses II himself chew the scenery like his Hollywood doppelganger, Yul Brynner: “So let it be written! So let it be done!”
 

To beard or not to beard

RyanJLane/E+

People are funny, and men, who happen to be people, are no exception.

Men, you see, have these things called beards, and there are definitely more men running around with facial hair these days. A lot of women go through a lot of trouble to get rid of a lot of their hair. But men, well, we grow extra hair. Why?

That’s what Honest Amish, a maker of beard-care products, wanted to know. They commissioned OnePoll to conduct a survey of 2,000 Americans, both men and women, to learn all kinds of things about beards.

So what did they find? Facial hair confidence, that’s what. Three-quarters of men said that a beard made them feel more confident than did a bare face, and 73% said that facial hair makes a man more attractive. That number was a bit lower among women, 63% of whom said that facial hair made a man more attractive.

That doesn’t seem very funny, does it? We’re getting there.

Male respondents also were asked what they would do to get the perfect beard: 40% would be willing to spend a night in jail or give up coffee for a year, and 38% would stand in line at the DMV for an entire day. Somewhat less popular responses included giving up sex for a year (22%) – seems like a waste of all that new-found confidence – and shaving their heads (18%).

And that, we don’t mind saying, is a hair-raising conclusion.




 

If I only had a nose

PeopleImages/E+

Deaf and blind people get all the attention. Special schools, Braille, sign language, even a pinball-focused rock opera. And it is easy to see why: Those senses are kind of important when it comes to navigating the world. But what if you have to live without one of the less-cool senses? What if the nose doesn’t know?

According to research published in Clinical Otolaryngology, up to 5% of the world’s population has some sort of smell disorder, preventing them from either smelling correctly or smelling anything at all. And the effects of this on everyday life are drastic.

In a survey of 71 people with smell disorders, the researchers found that patients experience a smorgasbord of negative effects – ranging from poor hazard perception and poor sense of personal hygiene, to an inability to enjoy food and an inability to link smell to happy memories. The whiff of gingerbread on Christmas morning, the smoke of a bonfire on a summer evening – the smell-deprived miss out on them all. The negative emotions those people experience read like a recipe for your very own homemade Sith lord: sadness, regret, isolation, anxiety, anger, frustration. A path to the dark side, losing your scent is.

Speaking of fictional bad guys, this nasal-based research really could have benefited one Lord Volde ... fine, You-Know-Who. Just look at that face. That’s a man who can’t smell. You can’t tell us he wouldn’t have turned out better if only Dorothy had picked him up on the yellow brick road instead of some dumb scarecrow.
 

The sound of hieroglyphics

stigalenas/iStock/Getty Images Plus

The Rosetta Stone revealed the meaning of Egyptian hieroglyphics and unlocked the ancient language of the Pharaohs for modern humans. But that mute stele said nothing about what those who uttered that ancient tongue sounded like.

Researchers at London’s Royal Holloway College may now know the answer. At least, a monosyllabic one.

The answer comes (indirectly) from Egyptian priest Nesyamun, a former resident of Thebes who worked at the temple of Karnak, but who now calls the Leeds City Museum home. Or, to be precise, Nesyamun’s 3,000-year-old mummified remains live on in Leeds. Nesyamun’s religious duties during his Karnak career likely required a smooth singing style and an accomplished speaking voice.

In a paper published in Scientific Reports, the British scientists say they’ve now heard the sound of the Egyptian priest’s long-silenced liturgical voice.

Working from CT scans of Nesyamun’s relatively well-preserved vocal-tract soft tissue, the scientists used a 3D-printed vocal tract and an electronic larynx to synthesize the actual sound of his voice.

And the result? Did the crooning priest of Karnak utter a Boris Karloffian curse upon those who had disturbed his millennia-long slumber? Did he deliver a rousing hymn of praise to Egypt’s ruler during the turbulent 1070s bce, Ramses XI?

In fact, what emerged from Nesyamun’s synthesized throat was ... “eh.” Maybe “a,” as in “bad.”

Given the state of the priest’s tongue (shrunken) and his soft palate (missing), the researchers say those monosyllabic sounds are the best Nesyamun can muster in his present state. Other experts say actual words from the ancients are likely impossible.

Perhaps one day, science will indeed be able to synthesize whole words or sentences from other well-preserved residents of the distant past. May we all live to hear an unyielding Ramses II himself chew the scenery like his Hollywood doppelganger, Yul Brynner: “So let it be written! So let it be done!”
 

To beard or not to beard

RyanJLane/E+

People are funny, and men, who happen to be people, are no exception.

Men, you see, have these things called beards, and there are definitely more men running around with facial hair these days. A lot of women go through a lot of trouble to get rid of a lot of their hair. But men, well, we grow extra hair. Why?

That’s what Honest Amish, a maker of beard-care products, wanted to know. They commissioned OnePoll to conduct a survey of 2,000 Americans, both men and women, to learn all kinds of things about beards.

So what did they find? Facial hair confidence, that’s what. Three-quarters of men said that a beard made them feel more confident than did a bare face, and 73% said that facial hair makes a man more attractive. That number was a bit lower among women, 63% of whom said that facial hair made a man more attractive.

That doesn’t seem very funny, does it? We’re getting there.

Male respondents also were asked what they would do to get the perfect beard: 40% would be willing to spend a night in jail or give up coffee for a year, and 38% would stand in line at the DMV for an entire day. Somewhat less popular responses included giving up sex for a year (22%) – seems like a waste of all that new-found confidence – and shaving their heads (18%).

And that, we don’t mind saying, is a hair-raising conclusion.




 

Imagine a patient suffering with horrible psoriasis for decades having failed “every available treatment.” Imagine him living all that time with “flaking, cracking, painful, itchy skin,” only to develop cirrhosis after exposure to toxic therapies.

Then imagine the experience for that patient when, 2 weeks after initiating treatment with a new interleukin-17 inhibitor, his skin clears completely.

“Two weeks later it’s all gone – it was a moment to behold,” said Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, who had cared for the man for many years before a psoriasis treatment revolution of sorts took the field of dermatology by storm.

“The progress has been breathtaking – there’s no other way to describe it – and it feels like a miracle every time I see a new patient who has tough disease and I have all these things to offer them,” he continued. “For most patients, I can really help them and make a major difference in their life.”

Much of the progress in psoriasis treatment in the past 50 years unfolded over the past 2 decades, with biologics emerging for psoriasis, said Mark Lebwohl, MD, Waldman professor of dermatology and chair of the Kimberly and Eric J. Waldman department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Lebwohl recounted some of his own experiences with psoriasis patients before the advent of treatments – particularly biologics – that have transformed practice.

There was a time when psoriasis patients had little more to turn to than the effective – but “disgusting” – Goeckerman Regimen involving cycles of UVB light exposure and topical crude coal tar application. Initially, the regimen, which was introduced in the 1920s, was used around the clock on an inpatient basis until the skin cleared, Dr. Lebwohl said.

In the 1970s, the immunosuppressive chemotherapy drug methotrexate became the first oral systemic therapy approved for severe psoriasis. For those with disabling disease, it offered some hope for relief, but only about 40% of patients achieved at least a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75), he said, adding that they did so at the expense of the liver and bone marrow. “But it was the only thing we had for severe psoriasis other than light treatments.”

In the 1980s and 1990s, oral retinoids emerged as a treatment for psoriasis, and the immunosuppressive drug cyclosporine used to prevent organ rejection in some transplant patients was found to clear psoriasis in affected transplant recipients. Although they brought relief to some patients with severe, disabling disease, these also came with a high price. “It’s not that effective, and it has lots of side effects ... and causes kidney damage in essentially 100% of patients,” Dr. Lebwohl said of cyclosporine.

“So we had treatments that worked, but because the side effects were sufficiently severe, a lot of patients were not treated,” he said.

Enter the biologics era

The early 2000s brought the first two approvals for psoriasis: alefacept (Amevive), a “modestly effective, but quite safe” immunosuppressive dimeric fusion protein approved in early 2003 for moderate to severe plaque psoriasis, and efalizumab (Raptiva), a recombinant humanized monoclonal antibody approved in October 2003; both were T-cell–targeted therapies. The former was withdrawn from the market voluntarily as newer agents became available, and the latter was withdrawn in 2009 because of a link with development of progressive multifocal leukoencephalopathy.

Tumor necrosis factor (TNF) blockers, which had been used effectively for RA and Crohn’s disease, emerged next, and were highly effective, much safer than the systemic treatments, and gained “very widespread use,” Dr. Lebwohl said.

Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, also a prolific researcher – and chair of the guidelines committee that published two new sets of guidelines for psoriasis treatment in 2019 – said that the field of dermatology was “late to the biologic evolution,” as many of the early biologics were first approved for PsA.

“But over the last 10 years, things have changed dramatically,” he said. “After that we suddenly leapt ahead of everybody. ... We now have 11 biologic drugs approved for psoriasis, which is more than any other disease has available.”

It’s been “highly exciting” to see this “evolution and revolution,” he commented, adding that one of the next challenges is to address the comorbidities, such as cardiovascular disease, associated with psoriasis.

“The big question now ... is if you improve skin and you improve joints, can you potentially reduce the risk of coronary artery disease,” he said. “Everybody is looking at that, and to me it’s one of the most exciting things that we’re doing.”

Work is ongoing to look at whether the IL-17s and IL-23s have “other indications outside of the skin and joints,” both within and outside of dermatology.

Like Dr. Gottlieb, Dr. Menter also mentioned the potential for hidradenitis suppurativa, and also for a condition that is rarely discussed or studied: genital psoriasis. Ixekizumab has recently been shown to work in about 75% of patients with genital psoriasis, he noted.

Another important area of research is the identification of biomarkers for predicting response and relapse, he said. For now, biomarker research has disappointed, he added, predicting that it will take at least 3-5 years before biomarkers to help guide treatment are identified.

Indeed, Dr. Gelfand, who also is director of the Psoriasis and Phototherapy Treatment Center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, agreed there is a need for research to improve treatment selection.

Advances are being made in genetics – with more than 80 different genes now identified as being related to psoriasis – and in medical informatics – which allow thousands of patients to be followed for years, he said, noting that this could elucidate immunopathological features that can improve treatments, predict and prevent comorbidity, and further improve outcomes.

“We also need care that is more patient centered,” he said, describing the ongoing pragmatic LITE trial of home- or office-based phototherapy for which he is the lead investigator, and other studies that he hopes will expand access to care.

Kenneth Brian Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, whose career started in the basic science immunology arena, added the need for expanding benefit to patients with more-moderate disease. Like Dr. Menter, he identified psoriasis as the area in medicine that has had the greatest degree of advancement, except perhaps for hepatitis C.

He described the process not as a “bench-to-bedside” story, but as a bedside-to-bench, then “back-to-bedside” story.

It was really about taking those early T-cell–targeted biologics and anti-TNF agents from bedside to bench with the realization of the importance of the IL-23 and IL-17 pathways, and that understanding led back to the bedside with the development of the newest agents – and to a “huge difference in patient’s lives.”

“But we’ve gotten so good at treating patients with severe disease ... the question now is how to take care of those with more-moderate disease,” he said, noting that a focus on cost and better delivery systems will be needed for that population.

That research is underway, and the future looks bright – and clear.
 

“I think with psoriasis therapy and where we’ve come in the last 20 years ... we have a hard time remembering what it was like before we had biologic agents” he said. “Our perspective has changed a lot, and sometimes we forget that.”

In fact, “psoriasis has sort of dragged dermatology into the world of modern clinical trial science, and we can now apply that to all sorts of other diseases,” he said. “The psoriasis trials were the first really well-done large-scale trials in dermatology, and I think that has given dermatology a real leg up in how we do clinical research and how we do evidence-based medicine.”

All of the doctors interviewed for this story have received funds and/or honoraria from, consulted with, are employed with, or served on the advisory boards of manufacturers of biologics. Dr. Gelfand is a copatent holder of resiquimod for treatment of cutaneous T-cell lymphoma and is deputy editor of the Journal of Investigative Dermatology.

sworcester@mdedge.com
 

Imagine a patient suffering with horrible psoriasis for decades having failed “every available treatment.” Imagine him living all that time with “flaking, cracking, painful, itchy skin,” only to develop cirrhosis after exposure to toxic therapies.

Then imagine the experience for that patient when, 2 weeks after initiating treatment with a new interleukin-17 inhibitor, his skin clears completely.

“Two weeks later it’s all gone – it was a moment to behold,” said Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, who had cared for the man for many years before a psoriasis treatment revolution of sorts took the field of dermatology by storm.

“The progress has been breathtaking – there’s no other way to describe it – and it feels like a miracle every time I see a new patient who has tough disease and I have all these things to offer them,” he continued. “For most patients, I can really help them and make a major difference in their life.”

Much of the progress in psoriasis treatment in the past 50 years unfolded over the past 2 decades, with biologics emerging for psoriasis, said Mark Lebwohl, MD, Waldman professor of dermatology and chair of the Kimberly and Eric J. Waldman department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Lebwohl recounted some of his own experiences with psoriasis patients before the advent of treatments – particularly biologics – that have transformed practice.

There was a time when psoriasis patients had little more to turn to than the effective – but “disgusting” – Goeckerman Regimen involving cycles of UVB light exposure and topical crude coal tar application. Initially, the regimen, which was introduced in the 1920s, was used around the clock on an inpatient basis until the skin cleared, Dr. Lebwohl said.

In the 1970s, the immunosuppressive chemotherapy drug methotrexate became the first oral systemic therapy approved for severe psoriasis. For those with disabling disease, it offered some hope for relief, but only about 40% of patients achieved at least a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75), he said, adding that they did so at the expense of the liver and bone marrow. “But it was the only thing we had for severe psoriasis other than light treatments.”

In the 1980s and 1990s, oral retinoids emerged as a treatment for psoriasis, and the immunosuppressive drug cyclosporine used to prevent organ rejection in some transplant patients was found to clear psoriasis in affected transplant recipients. Although they brought relief to some patients with severe, disabling disease, these also came with a high price. “It’s not that effective, and it has lots of side effects ... and causes kidney damage in essentially 100% of patients,” Dr. Lebwohl said of cyclosporine.

“So we had treatments that worked, but because the side effects were sufficiently severe, a lot of patients were not treated,” he said.

Enter the biologics era

The early 2000s brought the first two approvals for psoriasis: alefacept (Amevive), a “modestly effective, but quite safe” immunosuppressive dimeric fusion protein approved in early 2003 for moderate to severe plaque psoriasis, and efalizumab (Raptiva), a recombinant humanized monoclonal antibody approved in October 2003; both were T-cell–targeted therapies. The former was withdrawn from the market voluntarily as newer agents became available, and the latter was withdrawn in 2009 because of a link with development of progressive multifocal leukoencephalopathy.

Tumor necrosis factor (TNF) blockers, which had been used effectively for RA and Crohn’s disease, emerged next, and were highly effective, much safer than the systemic treatments, and gained “very widespread use,” Dr. Lebwohl said.

Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, also a prolific researcher – and chair of the guidelines committee that published two new sets of guidelines for psoriasis treatment in 2019 – said that the field of dermatology was “late to the biologic evolution,” as many of the early biologics were first approved for PsA.

“But over the last 10 years, things have changed dramatically,” he said. “After that we suddenly leapt ahead of everybody. ... We now have 11 biologic drugs approved for psoriasis, which is more than any other disease has available.”

It’s been “highly exciting” to see this “evolution and revolution,” he commented, adding that one of the next challenges is to address the comorbidities, such as cardiovascular disease, associated with psoriasis.

“The big question now ... is if you improve skin and you improve joints, can you potentially reduce the risk of coronary artery disease,” he said. “Everybody is looking at that, and to me it’s one of the most exciting things that we’re doing.”

Work is ongoing to look at whether the IL-17s and IL-23s have “other indications outside of the skin and joints,” both within and outside of dermatology.

Like Dr. Gottlieb, Dr. Menter also mentioned the potential for hidradenitis suppurativa, and also for a condition that is rarely discussed or studied: genital psoriasis. Ixekizumab has recently been shown to work in about 75% of patients with genital psoriasis, he noted.

Another important area of research is the identification of biomarkers for predicting response and relapse, he said. For now, biomarker research has disappointed, he added, predicting that it will take at least 3-5 years before biomarkers to help guide treatment are identified.

Indeed, Dr. Gelfand, who also is director of the Psoriasis and Phototherapy Treatment Center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, agreed there is a need for research to improve treatment selection.

Advances are being made in genetics – with more than 80 different genes now identified as being related to psoriasis – and in medical informatics – which allow thousands of patients to be followed for years, he said, noting that this could elucidate immunopathological features that can improve treatments, predict and prevent comorbidity, and further improve outcomes.

“We also need care that is more patient centered,” he said, describing the ongoing pragmatic LITE trial of home- or office-based phototherapy for which he is the lead investigator, and other studies that he hopes will expand access to care.

Kenneth Brian Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, whose career started in the basic science immunology arena, added the need for expanding benefit to patients with more-moderate disease. Like Dr. Menter, he identified psoriasis as the area in medicine that has had the greatest degree of advancement, except perhaps for hepatitis C.

He described the process not as a “bench-to-bedside” story, but as a bedside-to-bench, then “back-to-bedside” story.

It was really about taking those early T-cell–targeted biologics and anti-TNF agents from bedside to bench with the realization of the importance of the IL-23 and IL-17 pathways, and that understanding led back to the bedside with the development of the newest agents – and to a “huge difference in patient’s lives.”

“But we’ve gotten so good at treating patients with severe disease ... the question now is how to take care of those with more-moderate disease,” he said, noting that a focus on cost and better delivery systems will be needed for that population.

That research is underway, and the future looks bright – and clear.
 

“I think with psoriasis therapy and where we’ve come in the last 20 years ... we have a hard time remembering what it was like before we had biologic agents” he said. “Our perspective has changed a lot, and sometimes we forget that.”

In fact, “psoriasis has sort of dragged dermatology into the world of modern clinical trial science, and we can now apply that to all sorts of other diseases,” he said. “The psoriasis trials were the first really well-done large-scale trials in dermatology, and I think that has given dermatology a real leg up in how we do clinical research and how we do evidence-based medicine.”

All of the doctors interviewed for this story have received funds and/or honoraria from, consulted with, are employed with, or served on the advisory boards of manufacturers of biologics. Dr. Gelfand is a copatent holder of resiquimod for treatment of cutaneous T-cell lymphoma and is deputy editor of the Journal of Investigative Dermatology.

sworcester@mdedge.com
 

Imagine a patient suffering with horrible psoriasis for decades having failed “every available treatment.” Imagine him living all that time with “flaking, cracking, painful, itchy skin,” only to develop cirrhosis after exposure to toxic therapies.

Then imagine the experience for that patient when, 2 weeks after initiating treatment with a new interleukin-17 inhibitor, his skin clears completely.

“Two weeks later it’s all gone – it was a moment to behold,” said Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, who had cared for the man for many years before a psoriasis treatment revolution of sorts took the field of dermatology by storm.

“The progress has been breathtaking – there’s no other way to describe it – and it feels like a miracle every time I see a new patient who has tough disease and I have all these things to offer them,” he continued. “For most patients, I can really help them and make a major difference in their life.”

Much of the progress in psoriasis treatment in the past 50 years unfolded over the past 2 decades, with biologics emerging for psoriasis, said Mark Lebwohl, MD, Waldman professor of dermatology and chair of the Kimberly and Eric J. Waldman department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Lebwohl recounted some of his own experiences with psoriasis patients before the advent of treatments – particularly biologics – that have transformed practice.

There was a time when psoriasis patients had little more to turn to than the effective – but “disgusting” – Goeckerman Regimen involving cycles of UVB light exposure and topical crude coal tar application. Initially, the regimen, which was introduced in the 1920s, was used around the clock on an inpatient basis until the skin cleared, Dr. Lebwohl said.

In the 1970s, the immunosuppressive chemotherapy drug methotrexate became the first oral systemic therapy approved for severe psoriasis. For those with disabling disease, it offered some hope for relief, but only about 40% of patients achieved at least a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75), he said, adding that they did so at the expense of the liver and bone marrow. “But it was the only thing we had for severe psoriasis other than light treatments.”

In the 1980s and 1990s, oral retinoids emerged as a treatment for psoriasis, and the immunosuppressive drug cyclosporine used to prevent organ rejection in some transplant patients was found to clear psoriasis in affected transplant recipients. Although they brought relief to some patients with severe, disabling disease, these also came with a high price. “It’s not that effective, and it has lots of side effects ... and causes kidney damage in essentially 100% of patients,” Dr. Lebwohl said of cyclosporine.

“So we had treatments that worked, but because the side effects were sufficiently severe, a lot of patients were not treated,” he said.

Enter the biologics era

The early 2000s brought the first two approvals for psoriasis: alefacept (Amevive), a “modestly effective, but quite safe” immunosuppressive dimeric fusion protein approved in early 2003 for moderate to severe plaque psoriasis, and efalizumab (Raptiva), a recombinant humanized monoclonal antibody approved in October 2003; both were T-cell–targeted therapies. The former was withdrawn from the market voluntarily as newer agents became available, and the latter was withdrawn in 2009 because of a link with development of progressive multifocal leukoencephalopathy.

Tumor necrosis factor (TNF) blockers, which had been used effectively for RA and Crohn’s disease, emerged next, and were highly effective, much safer than the systemic treatments, and gained “very widespread use,” Dr. Lebwohl said.

Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, also a prolific researcher – and chair of the guidelines committee that published two new sets of guidelines for psoriasis treatment in 2019 – said that the field of dermatology was “late to the biologic evolution,” as many of the early biologics were first approved for PsA.

“But over the last 10 years, things have changed dramatically,” he said. “After that we suddenly leapt ahead of everybody. ... We now have 11 biologic drugs approved for psoriasis, which is more than any other disease has available.”

It’s been “highly exciting” to see this “evolution and revolution,” he commented, adding that one of the next challenges is to address the comorbidities, such as cardiovascular disease, associated with psoriasis.

“The big question now ... is if you improve skin and you improve joints, can you potentially reduce the risk of coronary artery disease,” he said. “Everybody is looking at that, and to me it’s one of the most exciting things that we’re doing.”

Work is ongoing to look at whether the IL-17s and IL-23s have “other indications outside of the skin and joints,” both within and outside of dermatology.

Like Dr. Gottlieb, Dr. Menter also mentioned the potential for hidradenitis suppurativa, and also for a condition that is rarely discussed or studied: genital psoriasis. Ixekizumab has recently been shown to work in about 75% of patients with genital psoriasis, he noted.

Another important area of research is the identification of biomarkers for predicting response and relapse, he said. For now, biomarker research has disappointed, he added, predicting that it will take at least 3-5 years before biomarkers to help guide treatment are identified.

Indeed, Dr. Gelfand, who also is director of the Psoriasis and Phototherapy Treatment Center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, agreed there is a need for research to improve treatment selection.

Advances are being made in genetics – with more than 80 different genes now identified as being related to psoriasis – and in medical informatics – which allow thousands of patients to be followed for years, he said, noting that this could elucidate immunopathological features that can improve treatments, predict and prevent comorbidity, and further improve outcomes.

“We also need care that is more patient centered,” he said, describing the ongoing pragmatic LITE trial of home- or office-based phototherapy for which he is the lead investigator, and other studies that he hopes will expand access to care.

Kenneth Brian Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, whose career started in the basic science immunology arena, added the need for expanding benefit to patients with more-moderate disease. Like Dr. Menter, he identified psoriasis as the area in medicine that has had the greatest degree of advancement, except perhaps for hepatitis C.

He described the process not as a “bench-to-bedside” story, but as a bedside-to-bench, then “back-to-bedside” story.

It was really about taking those early T-cell–targeted biologics and anti-TNF agents from bedside to bench with the realization of the importance of the IL-23 and IL-17 pathways, and that understanding led back to the bedside with the development of the newest agents – and to a “huge difference in patient’s lives.”

“But we’ve gotten so good at treating patients with severe disease ... the question now is how to take care of those with more-moderate disease,” he said, noting that a focus on cost and better delivery systems will be needed for that population.

That research is underway, and the future looks bright – and clear.
 

“I think with psoriasis therapy and where we’ve come in the last 20 years ... we have a hard time remembering what it was like before we had biologic agents” he said. “Our perspective has changed a lot, and sometimes we forget that.”

In fact, “psoriasis has sort of dragged dermatology into the world of modern clinical trial science, and we can now apply that to all sorts of other diseases,” he said. “The psoriasis trials were the first really well-done large-scale trials in dermatology, and I think that has given dermatology a real leg up in how we do clinical research and how we do evidence-based medicine.”

All of the doctors interviewed for this story have received funds and/or honoraria from, consulted with, are employed with, or served on the advisory boards of manufacturers of biologics. Dr. Gelfand is a copatent holder of resiquimod for treatment of cutaneous T-cell lymphoma and is deputy editor of the Journal of Investigative Dermatology.

sworcester@mdedge.com