Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

 

Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.

This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.

Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.

The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.

Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.

However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.

These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.

Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”

Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.

Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.

Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”

Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.

“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”

msullivan@mdege.com

 

Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

 

Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.

This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.

Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.

The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.

Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.

However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.

These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.

Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”

Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.

Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.

Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”

Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.

“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”

msullivan@mdege.com

 

Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

 

Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.

This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.

Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.

The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.

Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.

However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.

These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.

Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”

Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.

Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.

Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”

Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.

“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”

msullivan@mdege.com

 

Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

mlesney@mdedge.com

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

 

Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

mlesney@mdedge.com

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

 

Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

mlesney@mdedge.com

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

 

The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.

cyano66/Thinkstock

Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.

I don’t do that anymore.

This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.

Anonymous websites, by their very nature, tend to attract nastiness since the writers can’t be held accountable. As a result, many of them have turned from medical sites to political vitriol.

Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.

Makes it hard to actually kick around thoughts on Ocrevus (or whatever).

Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.

I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.

So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.

Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.

cyano66/Thinkstock

Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.

I don’t do that anymore.

This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.

Anonymous websites, by their very nature, tend to attract nastiness since the writers can’t be held accountable. As a result, many of them have turned from medical sites to political vitriol.

Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.

Makes it hard to actually kick around thoughts on Ocrevus (or whatever).

Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.

I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.

So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.

Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.

cyano66/Thinkstock

Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.

I don’t do that anymore.

This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.

Anonymous websites, by their very nature, tend to attract nastiness since the writers can’t be held accountable. As a result, many of them have turned from medical sites to political vitriol.

Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.

Makes it hard to actually kick around thoughts on Ocrevus (or whatever).

Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.

I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.

So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.

Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

LAS VEGAS – The way Robert Hudak, MD, sees it, the terms excessive anxiety and anxiety disorders are not interchangeable – and do not mean the same thing.

“People with anxiety disorders have excessive anxiety, but not everyone with excessive anxiety has a psychiatric disorder,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Any anxiety above baseline can be normal. It’s not necessarily pathological. I think that’s an important point that’s easy to overlook when we’re in clinical practice, and it affects how we approach our patients.”

Anxiety can present in a variety of ways in different individuals. Panic attacks are often the primary chief complaint, and it’s common to hear complaints from family that the person is routinely seeking reassurance. In addition, tics and twitches are not unusual in people with anxiety disorder. “Some of that is brought out by anxiety itself,” said Dr. Hudak, who is a psychiatrist at the University of Pittsburgh. Sleep disturbances or other somatic complaints also are common. “They complain of racing thoughts, increased energy, and depression,” he added. “When someone complains about depression, don’t assume they have a mood disorder. The reason people with anxiety disorders complain about depression is that it really feels awful. Anxiety is incredibly dysphoric.” Physical complaints include shortness of breath, GI distress, dizziness, vague somatic complaints, and skin or gum lesions.

He went on to note that individuals with excessive anxiety virtually never lose consciousness. “The exception is blood/injection/injury phobia,” he said. “That’s the only case in which anxiety will cause loss of consciousness. It happens in virtually no other setting. Ondine’s curse while falling asleep is another symptom that only occurs with anxiety. It’s a sensation that you have to remember to breathe, and breathing is no longer automatic. There are medical conditions that cause Ondine’s curse. However, the patient who complains of Ondine’s curse as they’re falling asleep is pathognomonic for anxiety.”

Dr. Hudak said panic attacks, a discrete period of fear or discomfort, rarely last more than 30 minutes.

“I view panic attacks in three flavors,” he said. “Some people have the cardiovascular flavor with shortness of breath and heart palpitations. Some have what I call the neurological flavor, where the predominant symptoms seem to be dizziness and tingling. Other people have GI flavor, with gut pain, nausea, and diarrhea. Panic attacks are not a psychiatric disorder. It’s a qualifier for any psychiatric disorder.”

Social anxiety disorder, meanwhile, presents as two completely distinct and separate illnesses that have nothing in common with each other.

“The performance subtype of social anxiety really presents like a simple phobia,” Dr. Hudak said. “The treatment for that is really behavioral therapy and cognitive-behavioral therapy, and rarely the use of medications. The generalized type presents with intrusive, [obsessive-compulsive disorder]–like thoughts. Affected individuals describe themselves as ‘paranoid’ or feeling that they are being scrutinized. The categorical versus dimensional diagnosis is being debated.” Individuals with generalized anxiety disorder, on the other hand, have excessive and pervasive worry and anxiety present more days than not for a 6-month period. “The individual finds it difficult to control the worry,” he said. Somatic symptoms include restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and insomnia. Different studies show the prevalence rate between 3% and 8%, affecting more women than men.

The medical work-up for excessive anxiety should consist of history and physical exam, complete blood count, the Chem-7 metabolic test, thyroid-stimulating hormone, and EKG if indicated. Both medications and behavioral therapy are used in the treatment of anxiety disorders. Many patients require both in order to achieve maximum treatment response. “Often, people with less severe illnesses can be managed with therapy alone,” Dr. Hudak said.

“In more severe cases, medications can help reduce symptoms to the point where therapy is easier to perform. The bottom line here is that at no time should you treat someone with an anxiety disorder with medications alone. Behavioral therapy is at least as effective as medications, and perhaps more so.”

Many trials of anxiety medications are of short duration and therefore lack evidence of long-term improvement, he said. Commonly used scales often include nonspecific items such as arousal score that can be reduced by sedating medications without improving the actual disorder. If someone has excessive anxiety that is not part of a primary anxiety disorder, Dr. Hudak typically prescribes benzodiazepines. “If someone is anxious because a loved one died, or if they’re nervous about their wedding day, or about taking a board exam, benzos can be used,” he said. “For someone who has an anxiety disorder, I virtually never use benzodiazepines. I generally use medications in the antidepressant category. I probably initiate fewer than five benzodiazepine prescriptions per year for anxiety disorder. There is also data to suggest that using benzodiazepines in patients with anxiety disorder may make cognitive-behavioral therapy more difficult.”

According to Dr. Hudak, selective serotonin reuptake inhibitors seem to have the largest evidence base in panic disorder and are first-line pharmacotherapy for both panic disorder and generalized anxiety disorder, while tricyclic antidepressants (TCAs) usually are considered a second-line therapy. “There is good data behind MAO inhibitors, and there is increasingly good data behind [selective norepinephrine reuptake inhibitors],” he said. “If someone has failed a trial of SSRIs, you may consider trying an SNRI before a TCA. However, I would try multiple SSRIs before ruling out that class of medications. I have had people fail five SSRIs and respond dramatically to the sixth SSRI.”

Dr. Hudak disclosed that he receives royalties from the Cambridge University Press.

dbrunk@mdedge.com

 

LAS VEGAS – The way Robert Hudak, MD, sees it, the terms excessive anxiety and anxiety disorders are not interchangeable – and do not mean the same thing.

“People with anxiety disorders have excessive anxiety, but not everyone with excessive anxiety has a psychiatric disorder,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Any anxiety above baseline can be normal. It’s not necessarily pathological. I think that’s an important point that’s easy to overlook when we’re in clinical practice, and it affects how we approach our patients.”

Anxiety can present in a variety of ways in different individuals. Panic attacks are often the primary chief complaint, and it’s common to hear complaints from family that the person is routinely seeking reassurance. In addition, tics and twitches are not unusual in people with anxiety disorder. “Some of that is brought out by anxiety itself,” said Dr. Hudak, who is a psychiatrist at the University of Pittsburgh. Sleep disturbances or other somatic complaints also are common. “They complain of racing thoughts, increased energy, and depression,” he added. “When someone complains about depression, don’t assume they have a mood disorder. The reason people with anxiety disorders complain about depression is that it really feels awful. Anxiety is incredibly dysphoric.” Physical complaints include shortness of breath, GI distress, dizziness, vague somatic complaints, and skin or gum lesions.

He went on to note that individuals with excessive anxiety virtually never lose consciousness. “The exception is blood/injection/injury phobia,” he said. “That’s the only case in which anxiety will cause loss of consciousness. It happens in virtually no other setting. Ondine’s curse while falling asleep is another symptom that only occurs with anxiety. It’s a sensation that you have to remember to breathe, and breathing is no longer automatic. There are medical conditions that cause Ondine’s curse. However, the patient who complains of Ondine’s curse as they’re falling asleep is pathognomonic for anxiety.”

Dr. Hudak said panic attacks, a discrete period of fear or discomfort, rarely last more than 30 minutes.

“I view panic attacks in three flavors,” he said. “Some people have the cardiovascular flavor with shortness of breath and heart palpitations. Some have what I call the neurological flavor, where the predominant symptoms seem to be dizziness and tingling. Other people have GI flavor, with gut pain, nausea, and diarrhea. Panic attacks are not a psychiatric disorder. It’s a qualifier for any psychiatric disorder.”

Social anxiety disorder, meanwhile, presents as two completely distinct and separate illnesses that have nothing in common with each other.

“The performance subtype of social anxiety really presents like a simple phobia,” Dr. Hudak said. “The treatment for that is really behavioral therapy and cognitive-behavioral therapy, and rarely the use of medications. The generalized type presents with intrusive, [obsessive-compulsive disorder]–like thoughts. Affected individuals describe themselves as ‘paranoid’ or feeling that they are being scrutinized. The categorical versus dimensional diagnosis is being debated.” Individuals with generalized anxiety disorder, on the other hand, have excessive and pervasive worry and anxiety present more days than not for a 6-month period. “The individual finds it difficult to control the worry,” he said. Somatic symptoms include restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and insomnia. Different studies show the prevalence rate between 3% and 8%, affecting more women than men.

The medical work-up for excessive anxiety should consist of history and physical exam, complete blood count, the Chem-7 metabolic test, thyroid-stimulating hormone, and EKG if indicated. Both medications and behavioral therapy are used in the treatment of anxiety disorders. Many patients require both in order to achieve maximum treatment response. “Often, people with less severe illnesses can be managed with therapy alone,” Dr. Hudak said.

“In more severe cases, medications can help reduce symptoms to the point where therapy is easier to perform. The bottom line here is that at no time should you treat someone with an anxiety disorder with medications alone. Behavioral therapy is at least as effective as medications, and perhaps more so.”

Many trials of anxiety medications are of short duration and therefore lack evidence of long-term improvement, he said. Commonly used scales often include nonspecific items such as arousal score that can be reduced by sedating medications without improving the actual disorder. If someone has excessive anxiety that is not part of a primary anxiety disorder, Dr. Hudak typically prescribes benzodiazepines. “If someone is anxious because a loved one died, or if they’re nervous about their wedding day, or about taking a board exam, benzos can be used,” he said. “For someone who has an anxiety disorder, I virtually never use benzodiazepines. I generally use medications in the antidepressant category. I probably initiate fewer than five benzodiazepine prescriptions per year for anxiety disorder. There is also data to suggest that using benzodiazepines in patients with anxiety disorder may make cognitive-behavioral therapy more difficult.”

According to Dr. Hudak, selective serotonin reuptake inhibitors seem to have the largest evidence base in panic disorder and are first-line pharmacotherapy for both panic disorder and generalized anxiety disorder, while tricyclic antidepressants (TCAs) usually are considered a second-line therapy. “There is good data behind MAO inhibitors, and there is increasingly good data behind [selective norepinephrine reuptake inhibitors],” he said. “If someone has failed a trial of SSRIs, you may consider trying an SNRI before a TCA. However, I would try multiple SSRIs before ruling out that class of medications. I have had people fail five SSRIs and respond dramatically to the sixth SSRI.”

Dr. Hudak disclosed that he receives royalties from the Cambridge University Press.

dbrunk@mdedge.com

 

LAS VEGAS – The way Robert Hudak, MD, sees it, the terms excessive anxiety and anxiety disorders are not interchangeable – and do not mean the same thing.

“People with anxiety disorders have excessive anxiety, but not everyone with excessive anxiety has a psychiatric disorder,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Any anxiety above baseline can be normal. It’s not necessarily pathological. I think that’s an important point that’s easy to overlook when we’re in clinical practice, and it affects how we approach our patients.”

Anxiety can present in a variety of ways in different individuals. Panic attacks are often the primary chief complaint, and it’s common to hear complaints from family that the person is routinely seeking reassurance. In addition, tics and twitches are not unusual in people with anxiety disorder. “Some of that is brought out by anxiety itself,” said Dr. Hudak, who is a psychiatrist at the University of Pittsburgh. Sleep disturbances or other somatic complaints also are common. “They complain of racing thoughts, increased energy, and depression,” he added. “When someone complains about depression, don’t assume they have a mood disorder. The reason people with anxiety disorders complain about depression is that it really feels awful. Anxiety is incredibly dysphoric.” Physical complaints include shortness of breath, GI distress, dizziness, vague somatic complaints, and skin or gum lesions.

He went on to note that individuals with excessive anxiety virtually never lose consciousness. “The exception is blood/injection/injury phobia,” he said. “That’s the only case in which anxiety will cause loss of consciousness. It happens in virtually no other setting. Ondine’s curse while falling asleep is another symptom that only occurs with anxiety. It’s a sensation that you have to remember to breathe, and breathing is no longer automatic. There are medical conditions that cause Ondine’s curse. However, the patient who complains of Ondine’s curse as they’re falling asleep is pathognomonic for anxiety.”

Dr. Hudak said panic attacks, a discrete period of fear or discomfort, rarely last more than 30 minutes.

“I view panic attacks in three flavors,” he said. “Some people have the cardiovascular flavor with shortness of breath and heart palpitations. Some have what I call the neurological flavor, where the predominant symptoms seem to be dizziness and tingling. Other people have GI flavor, with gut pain, nausea, and diarrhea. Panic attacks are not a psychiatric disorder. It’s a qualifier for any psychiatric disorder.”

Social anxiety disorder, meanwhile, presents as two completely distinct and separate illnesses that have nothing in common with each other.

“The performance subtype of social anxiety really presents like a simple phobia,” Dr. Hudak said. “The treatment for that is really behavioral therapy and cognitive-behavioral therapy, and rarely the use of medications. The generalized type presents with intrusive, [obsessive-compulsive disorder]–like thoughts. Affected individuals describe themselves as ‘paranoid’ or feeling that they are being scrutinized. The categorical versus dimensional diagnosis is being debated.” Individuals with generalized anxiety disorder, on the other hand, have excessive and pervasive worry and anxiety present more days than not for a 6-month period. “The individual finds it difficult to control the worry,” he said. Somatic symptoms include restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and insomnia. Different studies show the prevalence rate between 3% and 8%, affecting more women than men.

The medical work-up for excessive anxiety should consist of history and physical exam, complete blood count, the Chem-7 metabolic test, thyroid-stimulating hormone, and EKG if indicated. Both medications and behavioral therapy are used in the treatment of anxiety disorders. Many patients require both in order to achieve maximum treatment response. “Often, people with less severe illnesses can be managed with therapy alone,” Dr. Hudak said.

“In more severe cases, medications can help reduce symptoms to the point where therapy is easier to perform. The bottom line here is that at no time should you treat someone with an anxiety disorder with medications alone. Behavioral therapy is at least as effective as medications, and perhaps more so.”

Many trials of anxiety medications are of short duration and therefore lack evidence of long-term improvement, he said. Commonly used scales often include nonspecific items such as arousal score that can be reduced by sedating medications without improving the actual disorder. If someone has excessive anxiety that is not part of a primary anxiety disorder, Dr. Hudak typically prescribes benzodiazepines. “If someone is anxious because a loved one died, or if they’re nervous about their wedding day, or about taking a board exam, benzos can be used,” he said. “For someone who has an anxiety disorder, I virtually never use benzodiazepines. I generally use medications in the antidepressant category. I probably initiate fewer than five benzodiazepine prescriptions per year for anxiety disorder. There is also data to suggest that using benzodiazepines in patients with anxiety disorder may make cognitive-behavioral therapy more difficult.”

According to Dr. Hudak, selective serotonin reuptake inhibitors seem to have the largest evidence base in panic disorder and are first-line pharmacotherapy for both panic disorder and generalized anxiety disorder, while tricyclic antidepressants (TCAs) usually are considered a second-line therapy. “There is good data behind MAO inhibitors, and there is increasingly good data behind [selective norepinephrine reuptake inhibitors],” he said. “If someone has failed a trial of SSRIs, you may consider trying an SNRI before a TCA. However, I would try multiple SSRIs before ruling out that class of medications. I have had people fail five SSRIs and respond dramatically to the sixth SSRI.”

Dr. Hudak disclosed that he receives royalties from the Cambridge University Press.

dbrunk@mdedge.com

 

To fight burnout, Griffin Myers, MD, wants more out of the physicians who work at Chicago-based Oak Street Health.

Courtesy Oak Street Health

Not more time, or more patients, or more codes billed – but more passion and a more meaningful professional experience, said Dr. Myers, cofounder and chief medical officer of the 42-practice group that cares for Medicare patients.

Oak Street seems to be on to something. According to the health care consultancy The Advisory Board, there are three key ways to avoid physician burnout: involve physicians in strategic decision making, recognize physicians’ contributions, and create time-limited leadership opportunities for physicians.

“What do you want to be when you grow up?”

That’s the question Dr. Myers asks physicians during job interviews. He wants to discover their personal and professional passions.

Health care leaders can’t expect physicians to prevent burnout on their own, insists Dr. Myers. “You have to change the way your organization supports clinicians.”

At Oak Street, that includes supporting physicians with medical scribes and ensuring that they aren’t bogged down with paperwork or “fighting with the fax machines,” said Dr. Myers.

Once a physician is hired at Oak Street, they’re partnered with a medical director who uses the practice’s resources to support the physician’s clinical and professional passions. Specifically, that means providing physicians with administrative time (nonpatient time) and support – both organizationally and financially – for professional development. Medical directors meet with physicians quarterly to check in and assess performance.

Courtesy Oak Street Health

Take, for example, Tina Valdez, DO, an internist at Oak Street’s Englewood, Ill., location, who previously practiced at Advocate Lutheran General Hospital in Park Ridge, Ill. During the job interview process, Dr. Myers discovered that Dr. Valdez wanted to keep teaching and mentoring residents as they transitioned to attending physicians.

Dr. Myers was on board, so Dr. Valdez uses her administrative time to meet with early-career physicians on a quarterly basis.

Resident physicians are used to having a more senior physician monitor their work, Dr. Valdez noted. Without that oversight, many first-year physicians can get anxious. To support them, she leads small group discussions on topics including patient cases and ways to better work with other members of the care team, such as relying on a medical assistant to capture vital signs and conduct a thorough medication reconciliation.

 

In the program’s first year, 10 new physicians split into two groups for 2-hour sessions at an off-site meeting location once a quarter.

As much as early-career physicians need support, so, too, do future leaders.

Courtesy Oak Street Health

When Andrea Khosropour, MD, first joined Oak Street in 2012, her mentor invested a lot of time in coaching her to become a better leader. For example, her mentor taught her the right way to have difficult conversations.

Dr. Khosropour, now a senior medical director who practices at the group’s Edgewater, Ill., location, said she finds balance at work because Oak Street gives her administrative time to attend to her management responsibilities. She also values the assistance of the medical scribes who document every patient encounter in the EHR. “That’s rare for primary care,” says Dr. Khosropour.

What qualities does Oak Street look for in its physician leaders? Dr. Myers said it starts with a physician who shares the group’s values, demonstrates clinical excellence and “scrappiness,” and has good intentions. He pointed out that Dr. Khosropour, who now oversees four practices, came to Oak Street with no experience running multiple practices.

Dr. Myers said Oak Street can grow its physicians internally as long as they share the group’s cultural values. “You can’t wait for people who already have those skills.”

Oak Street doesn’t rely on a fee-for-service model, in which physicians are paid by the volume of patients they treat. Specifically, that means 80% of its patients are in value-based contracts with private payers and the remaining patients are covered in the Medicare Shared Savings Program. About half of patients are dually eligible for Medicare and Medicaid, Dr. Myers said.

Because the group receives a set amount to manage the care of each of its attributed patients, Oak Street has the flexibility to invest in professional development, scribes, and other programs to support physicians, Dr. Myers said. That’s provided the group can successfully manage the care of their patients and keep them out of the hospital.

He advises practices that are more dependent on fee-for-service contracts to prioritize the following initiatives to prevent burnout: investing in professional development, reducing physicians’ administrative burdens, and celebrating physicians’ victories.

“Our goal is to provide the highest-quality health care employee experience possible. People will stay as long as you set that as a clear goal,” Dr. Myers said.


 

 

To fight burnout, Griffin Myers, MD, wants more out of the physicians who work at Chicago-based Oak Street Health.

Courtesy Oak Street Health

Not more time, or more patients, or more codes billed – but more passion and a more meaningful professional experience, said Dr. Myers, cofounder and chief medical officer of the 42-practice group that cares for Medicare patients.

Oak Street seems to be on to something. According to the health care consultancy The Advisory Board, there are three key ways to avoid physician burnout: involve physicians in strategic decision making, recognize physicians’ contributions, and create time-limited leadership opportunities for physicians.

“What do you want to be when you grow up?”

That’s the question Dr. Myers asks physicians during job interviews. He wants to discover their personal and professional passions.

Health care leaders can’t expect physicians to prevent burnout on their own, insists Dr. Myers. “You have to change the way your organization supports clinicians.”

At Oak Street, that includes supporting physicians with medical scribes and ensuring that they aren’t bogged down with paperwork or “fighting with the fax machines,” said Dr. Myers.

Once a physician is hired at Oak Street, they’re partnered with a medical director who uses the practice’s resources to support the physician’s clinical and professional passions. Specifically, that means providing physicians with administrative time (nonpatient time) and support – both organizationally and financially – for professional development. Medical directors meet with physicians quarterly to check in and assess performance.

Courtesy Oak Street Health

Take, for example, Tina Valdez, DO, an internist at Oak Street’s Englewood, Ill., location, who previously practiced at Advocate Lutheran General Hospital in Park Ridge, Ill. During the job interview process, Dr. Myers discovered that Dr. Valdez wanted to keep teaching and mentoring residents as they transitioned to attending physicians.

Dr. Myers was on board, so Dr. Valdez uses her administrative time to meet with early-career physicians on a quarterly basis.

Resident physicians are used to having a more senior physician monitor their work, Dr. Valdez noted. Without that oversight, many first-year physicians can get anxious. To support them, she leads small group discussions on topics including patient cases and ways to better work with other members of the care team, such as relying on a medical assistant to capture vital signs and conduct a thorough medication reconciliation.

 

In the program’s first year, 10 new physicians split into two groups for 2-hour sessions at an off-site meeting location once a quarter.

As much as early-career physicians need support, so, too, do future leaders.

Courtesy Oak Street Health

When Andrea Khosropour, MD, first joined Oak Street in 2012, her mentor invested a lot of time in coaching her to become a better leader. For example, her mentor taught her the right way to have difficult conversations.

Dr. Khosropour, now a senior medical director who practices at the group’s Edgewater, Ill., location, said she finds balance at work because Oak Street gives her administrative time to attend to her management responsibilities. She also values the assistance of the medical scribes who document every patient encounter in the EHR. “That’s rare for primary care,” says Dr. Khosropour.

What qualities does Oak Street look for in its physician leaders? Dr. Myers said it starts with a physician who shares the group’s values, demonstrates clinical excellence and “scrappiness,” and has good intentions. He pointed out that Dr. Khosropour, who now oversees four practices, came to Oak Street with no experience running multiple practices.

Dr. Myers said Oak Street can grow its physicians internally as long as they share the group’s cultural values. “You can’t wait for people who already have those skills.”

Oak Street doesn’t rely on a fee-for-service model, in which physicians are paid by the volume of patients they treat. Specifically, that means 80% of its patients are in value-based contracts with private payers and the remaining patients are covered in the Medicare Shared Savings Program. About half of patients are dually eligible for Medicare and Medicaid, Dr. Myers said.

Because the group receives a set amount to manage the care of each of its attributed patients, Oak Street has the flexibility to invest in professional development, scribes, and other programs to support physicians, Dr. Myers said. That’s provided the group can successfully manage the care of their patients and keep them out of the hospital.

He advises practices that are more dependent on fee-for-service contracts to prioritize the following initiatives to prevent burnout: investing in professional development, reducing physicians’ administrative burdens, and celebrating physicians’ victories.

“Our goal is to provide the highest-quality health care employee experience possible. People will stay as long as you set that as a clear goal,” Dr. Myers said.


 

 

To fight burnout, Griffin Myers, MD, wants more out of the physicians who work at Chicago-based Oak Street Health.

Courtesy Oak Street Health

Not more time, or more patients, or more codes billed – but more passion and a more meaningful professional experience, said Dr. Myers, cofounder and chief medical officer of the 42-practice group that cares for Medicare patients.

Oak Street seems to be on to something. According to the health care consultancy The Advisory Board, there are three key ways to avoid physician burnout: involve physicians in strategic decision making, recognize physicians’ contributions, and create time-limited leadership opportunities for physicians.

“What do you want to be when you grow up?”

That’s the question Dr. Myers asks physicians during job interviews. He wants to discover their personal and professional passions.

Health care leaders can’t expect physicians to prevent burnout on their own, insists Dr. Myers. “You have to change the way your organization supports clinicians.”

At Oak Street, that includes supporting physicians with medical scribes and ensuring that they aren’t bogged down with paperwork or “fighting with the fax machines,” said Dr. Myers.

Once a physician is hired at Oak Street, they’re partnered with a medical director who uses the practice’s resources to support the physician’s clinical and professional passions. Specifically, that means providing physicians with administrative time (nonpatient time) and support – both organizationally and financially – for professional development. Medical directors meet with physicians quarterly to check in and assess performance.

Courtesy Oak Street Health

Take, for example, Tina Valdez, DO, an internist at Oak Street’s Englewood, Ill., location, who previously practiced at Advocate Lutheran General Hospital in Park Ridge, Ill. During the job interview process, Dr. Myers discovered that Dr. Valdez wanted to keep teaching and mentoring residents as they transitioned to attending physicians.

Dr. Myers was on board, so Dr. Valdez uses her administrative time to meet with early-career physicians on a quarterly basis.

Resident physicians are used to having a more senior physician monitor their work, Dr. Valdez noted. Without that oversight, many first-year physicians can get anxious. To support them, she leads small group discussions on topics including patient cases and ways to better work with other members of the care team, such as relying on a medical assistant to capture vital signs and conduct a thorough medication reconciliation.

 

In the program’s first year, 10 new physicians split into two groups for 2-hour sessions at an off-site meeting location once a quarter.

As much as early-career physicians need support, so, too, do future leaders.

Courtesy Oak Street Health

When Andrea Khosropour, MD, first joined Oak Street in 2012, her mentor invested a lot of time in coaching her to become a better leader. For example, her mentor taught her the right way to have difficult conversations.

Dr. Khosropour, now a senior medical director who practices at the group’s Edgewater, Ill., location, said she finds balance at work because Oak Street gives her administrative time to attend to her management responsibilities. She also values the assistance of the medical scribes who document every patient encounter in the EHR. “That’s rare for primary care,” says Dr. Khosropour.

What qualities does Oak Street look for in its physician leaders? Dr. Myers said it starts with a physician who shares the group’s values, demonstrates clinical excellence and “scrappiness,” and has good intentions. He pointed out that Dr. Khosropour, who now oversees four practices, came to Oak Street with no experience running multiple practices.

Dr. Myers said Oak Street can grow its physicians internally as long as they share the group’s cultural values. “You can’t wait for people who already have those skills.”

Oak Street doesn’t rely on a fee-for-service model, in which physicians are paid by the volume of patients they treat. Specifically, that means 80% of its patients are in value-based contracts with private payers and the remaining patients are covered in the Medicare Shared Savings Program. About half of patients are dually eligible for Medicare and Medicaid, Dr. Myers said.

Because the group receives a set amount to manage the care of each of its attributed patients, Oak Street has the flexibility to invest in professional development, scribes, and other programs to support physicians, Dr. Myers said. That’s provided the group can successfully manage the care of their patients and keep them out of the hospital.

He advises practices that are more dependent on fee-for-service contracts to prioritize the following initiatives to prevent burnout: investing in professional development, reducing physicians’ administrative burdens, and celebrating physicians’ victories.

“Our goal is to provide the highest-quality health care employee experience possible. People will stay as long as you set that as a clear goal,” Dr. Myers said.


 

 

Although the total number of primary care physicians increased from 2005 to 2015, disproportionate losses across counties and general population increases have created an imbalance that may affect life expectancy, according to a study of U.S. population data and individual-level claims data linked to mortality.

©Tim Pannel/Fuse/Thinkstock

“Greater primary care physician supply was associated with lower population mortality, suggesting that observed decreases in primary care physician supply may have important consequences for population health,” wrote lead author Sanjay Basu, MD, PhD, of Stanford (Calif.) University and his coauthors. The study was published online in JAMA Internal Medicine.

Dr. Basu and his colleagues gathered data from 3,142 U.S. counties, 7,144 primary care service areas, and 306 hospital referral regions over a 10-year period to determine whether primary care physician supply was correlated with changes in life expectancy and cause-specific mortality. They found that, from 2005 to 2015, the total number of primary care physicians increased from 196,014 to 204,419. However, mean primary care physician supply decreased from 46.6 per 100,000 population (95% confidence interval, 0.0-114.6 per 100,000 population) to 41.4 per 100,000 (95% CI, 0.0-108.6).

In the researchers’ fully adjusted models, an increase of 10 primary care physicians per 100,000 population was associated with a 51.5-day increase in life expectancy (95% CI, 29.5-73.5 days; 0.2% increase). This effect was more favorable than the foreseen result of a similar increase of 10 specialist physicians per 100,000 population, which was associated with a 19.2-day increase in life expectancy (95% CI, 7.0-31.3).

Almost 300 (296) counties had no primary care physicians in 2015, while 128 counties had more than 100 per 100,000 population. On average, rural areas saw a larger decrease than urban areas (–7.0 per 100,000 population vs –2.6 per 100,000 population). Primary care physician supply did not disproportionately decrease by county poverty level or racial/ethnic demographics.

The coauthors shared their study’s limitations, including the use of private insurance data to conduct individual-level analyses and the possibility for unobserved confounding. However, they also noted that their results reinforced earlier findings on primary care physician density and overall life expectancy, calling for “future investigations [to] acquire data on the quality and comprehensiveness of primary care, types of primary care physician training and service delivery offerings, and effective access rather than just supply.”

The study was supported by the National Institutes of Health; data was accessed through the Stanford Center for Population Health Sciences Data Core, which is supported by the National Center for Advancing Translational Sciences and by Stanford University. One author reported being a senior adviser at the Center for Medicare & Medicaid Innovation; another reported being an adviser to Bicycle Health. No conflicts of interest were reported.

SOURCE: Basu S et al. JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7624.

 

Although the total number of primary care physicians increased from 2005 to 2015, disproportionate losses across counties and general population increases have created an imbalance that may affect life expectancy, according to a study of U.S. population data and individual-level claims data linked to mortality.

©Tim Pannel/Fuse/Thinkstock

“Greater primary care physician supply was associated with lower population mortality, suggesting that observed decreases in primary care physician supply may have important consequences for population health,” wrote lead author Sanjay Basu, MD, PhD, of Stanford (Calif.) University and his coauthors. The study was published online in JAMA Internal Medicine.

Dr. Basu and his colleagues gathered data from 3,142 U.S. counties, 7,144 primary care service areas, and 306 hospital referral regions over a 10-year period to determine whether primary care physician supply was correlated with changes in life expectancy and cause-specific mortality. They found that, from 2005 to 2015, the total number of primary care physicians increased from 196,014 to 204,419. However, mean primary care physician supply decreased from 46.6 per 100,000 population (95% confidence interval, 0.0-114.6 per 100,000 population) to 41.4 per 100,000 (95% CI, 0.0-108.6).

In the researchers’ fully adjusted models, an increase of 10 primary care physicians per 100,000 population was associated with a 51.5-day increase in life expectancy (95% CI, 29.5-73.5 days; 0.2% increase). This effect was more favorable than the foreseen result of a similar increase of 10 specialist physicians per 100,000 population, which was associated with a 19.2-day increase in life expectancy (95% CI, 7.0-31.3).

Almost 300 (296) counties had no primary care physicians in 2015, while 128 counties had more than 100 per 100,000 population. On average, rural areas saw a larger decrease than urban areas (–7.0 per 100,000 population vs –2.6 per 100,000 population). Primary care physician supply did not disproportionately decrease by county poverty level or racial/ethnic demographics.

The coauthors shared their study’s limitations, including the use of private insurance data to conduct individual-level analyses and the possibility for unobserved confounding. However, they also noted that their results reinforced earlier findings on primary care physician density and overall life expectancy, calling for “future investigations [to] acquire data on the quality and comprehensiveness of primary care, types of primary care physician training and service delivery offerings, and effective access rather than just supply.”

The study was supported by the National Institutes of Health; data was accessed through the Stanford Center for Population Health Sciences Data Core, which is supported by the National Center for Advancing Translational Sciences and by Stanford University. One author reported being a senior adviser at the Center for Medicare & Medicaid Innovation; another reported being an adviser to Bicycle Health. No conflicts of interest were reported.

SOURCE: Basu S et al. JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7624.

 

Although the total number of primary care physicians increased from 2005 to 2015, disproportionate losses across counties and general population increases have created an imbalance that may affect life expectancy, according to a study of U.S. population data and individual-level claims data linked to mortality.

©Tim Pannel/Fuse/Thinkstock

“Greater primary care physician supply was associated with lower population mortality, suggesting that observed decreases in primary care physician supply may have important consequences for population health,” wrote lead author Sanjay Basu, MD, PhD, of Stanford (Calif.) University and his coauthors. The study was published online in JAMA Internal Medicine.

Dr. Basu and his colleagues gathered data from 3,142 U.S. counties, 7,144 primary care service areas, and 306 hospital referral regions over a 10-year period to determine whether primary care physician supply was correlated with changes in life expectancy and cause-specific mortality. They found that, from 2005 to 2015, the total number of primary care physicians increased from 196,014 to 204,419. However, mean primary care physician supply decreased from 46.6 per 100,000 population (95% confidence interval, 0.0-114.6 per 100,000 population) to 41.4 per 100,000 (95% CI, 0.0-108.6).

In the researchers’ fully adjusted models, an increase of 10 primary care physicians per 100,000 population was associated with a 51.5-day increase in life expectancy (95% CI, 29.5-73.5 days; 0.2% increase). This effect was more favorable than the foreseen result of a similar increase of 10 specialist physicians per 100,000 population, which was associated with a 19.2-day increase in life expectancy (95% CI, 7.0-31.3).

Almost 300 (296) counties had no primary care physicians in 2015, while 128 counties had more than 100 per 100,000 population. On average, rural areas saw a larger decrease than urban areas (–7.0 per 100,000 population vs –2.6 per 100,000 population). Primary care physician supply did not disproportionately decrease by county poverty level or racial/ethnic demographics.

The coauthors shared their study’s limitations, including the use of private insurance data to conduct individual-level analyses and the possibility for unobserved confounding. However, they also noted that their results reinforced earlier findings on primary care physician density and overall life expectancy, calling for “future investigations [to] acquire data on the quality and comprehensiveness of primary care, types of primary care physician training and service delivery offerings, and effective access rather than just supply.”

The study was supported by the National Institutes of Health; data was accessed through the Stanford Center for Population Health Sciences Data Core, which is supported by the National Center for Advancing Translational Sciences and by Stanford University. One author reported being a senior adviser at the Center for Medicare & Medicaid Innovation; another reported being an adviser to Bicycle Health. No conflicts of interest were reported.

SOURCE: Basu S et al. JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7624.

SAN DIEGO – A nationally representative survey of ICU patients older than age 65 years shows an improvement over time in the frequency of advance care planning (ACP), but one in four have no ACP; the problem is more pronounced among some blacks and Hispanics and those with lower net worth. The study also found that these patients see physicians an average of 20 times in the year preceding the ICU visit, which suggests that there are plenty of opportunities to put ACP in place.

marcosmartinezromero/iStockphoto

“Over two-thirds were seen by a doctor in the last 2 weeks. So they’re seeing doctors, but they’re still not doing advance care planning,” said Brian Block, MD, during a presentation of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. Dr. Block is with the University of California, San Francisco.

Lack of advance planning can put major road blocks in front of patient care in the ICU, as well as complicate communication between physicians and family members. The findings underscore the need to encourage conversations about end-of-life care between physicians and their patients – before the patients wind up in intensive care.

One audience member believes these conversations are already happening. Paul Yodice, MD, chairman of medicine at Saint Barnabas Medical Center in Livingston, N.J., suggested that physicians are attempting to engage older patients and family members in ACP, but many are unready to make decisions. “In my experience, it is happening much more frequently than is captured either in the medical record or in the research that we’ve been publishing. I’ve been a part of those conversations. Those individuals who are faced with those toughest of choices choose to delay making the decision or speaking about it further because it’s just too painful to consider, and they hold out hope of being the one to beat the odds, to have one more day,” said Dr. Yodice.

He called for further research to document whether ACP conversations are happening and to identify barriers to decisions and the means to overcome them. “A next good study would be to send out a respectful survey to the families of those who have lost people they love and ask: Has someone in the past year spoken with you or offered to have a discussion about end-of-life issues? We could get a better handle on [how often] the discussion is being had, and then find a solution,” said Dr. Yodice.

ACP can also be difficult for the provider, he added. Family members and patients, desperate for another treatment option, will often ask if there’s anything else that can be done. “In medicine, the answer almost always is ‘Well, we can try something else even though I know it’s not going to work.’ And people hold on to that, including us,” said Dr. Yodice.

The study analyzed data from a Medicare cohort of 1,109 patients who died during 2000-2013 and had an ICU admission within the last 30 days of their life. Ages were fairly evenly distributed, with 29% aged 65-74 years, 39% aged 75-84, and 32% aged 85 and over. Fifty-four percent were women, 26% were nonwhite, 42% had not completed high school, and 11% were in skilled nursing facilities.

About 35% had no ACP in 2000-2001, and that percentage gradually declined, to about 20% in 2012-2013 (slope, –1.6%/year; P = .009).

Seventeen percent of white participants had no ACP, compared with 51% of blacks and 49% of Hispanics. Net worth was also strongly associated with having ACP: The top quartile had 13% lacking ACP, compared with 43% of the bottom quartile.

The study found that 94% of patients who had no ACP had visited a health care provider in the past year. The average number of visits in the past year was 20, and 83% had seen a provider within the past 30 days.

Dr. Block did not declare a source of funding or potential conflicts. Dr. Yodice had no disclosures.
 

chestphysiciannews@chestnet.org

SOURCE: Block B et al. CCC48, Abstract 401.

SAN DIEGO – A nationally representative survey of ICU patients older than age 65 years shows an improvement over time in the frequency of advance care planning (ACP), but one in four have no ACP; the problem is more pronounced among some blacks and Hispanics and those with lower net worth. The study also found that these patients see physicians an average of 20 times in the year preceding the ICU visit, which suggests that there are plenty of opportunities to put ACP in place.

marcosmartinezromero/iStockphoto

“Over two-thirds were seen by a doctor in the last 2 weeks. So they’re seeing doctors, but they’re still not doing advance care planning,” said Brian Block, MD, during a presentation of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. Dr. Block is with the University of California, San Francisco.

Lack of advance planning can put major road blocks in front of patient care in the ICU, as well as complicate communication between physicians and family members. The findings underscore the need to encourage conversations about end-of-life care between physicians and their patients – before the patients wind up in intensive care.

One audience member believes these conversations are already happening. Paul Yodice, MD, chairman of medicine at Saint Barnabas Medical Center in Livingston, N.J., suggested that physicians are attempting to engage older patients and family members in ACP, but many are unready to make decisions. “In my experience, it is happening much more frequently than is captured either in the medical record or in the research that we’ve been publishing. I’ve been a part of those conversations. Those individuals who are faced with those toughest of choices choose to delay making the decision or speaking about it further because it’s just too painful to consider, and they hold out hope of being the one to beat the odds, to have one more day,” said Dr. Yodice.

He called for further research to document whether ACP conversations are happening and to identify barriers to decisions and the means to overcome them. “A next good study would be to send out a respectful survey to the families of those who have lost people they love and ask: Has someone in the past year spoken with you or offered to have a discussion about end-of-life issues? We could get a better handle on [how often] the discussion is being had, and then find a solution,” said Dr. Yodice.

ACP can also be difficult for the provider, he added. Family members and patients, desperate for another treatment option, will often ask if there’s anything else that can be done. “In medicine, the answer almost always is ‘Well, we can try something else even though I know it’s not going to work.’ And people hold on to that, including us,” said Dr. Yodice.

The study analyzed data from a Medicare cohort of 1,109 patients who died during 2000-2013 and had an ICU admission within the last 30 days of their life. Ages were fairly evenly distributed, with 29% aged 65-74 years, 39% aged 75-84, and 32% aged 85 and over. Fifty-four percent were women, 26% were nonwhite, 42% had not completed high school, and 11% were in skilled nursing facilities.

About 35% had no ACP in 2000-2001, and that percentage gradually declined, to about 20% in 2012-2013 (slope, –1.6%/year; P = .009).

Seventeen percent of white participants had no ACP, compared with 51% of blacks and 49% of Hispanics. Net worth was also strongly associated with having ACP: The top quartile had 13% lacking ACP, compared with 43% of the bottom quartile.

The study found that 94% of patients who had no ACP had visited a health care provider in the past year. The average number of visits in the past year was 20, and 83% had seen a provider within the past 30 days.

Dr. Block did not declare a source of funding or potential conflicts. Dr. Yodice had no disclosures.
 

chestphysiciannews@chestnet.org

SOURCE: Block B et al. CCC48, Abstract 401.

SAN DIEGO – A nationally representative survey of ICU patients older than age 65 years shows an improvement over time in the frequency of advance care planning (ACP), but one in four have no ACP; the problem is more pronounced among some blacks and Hispanics and those with lower net worth. The study also found that these patients see physicians an average of 20 times in the year preceding the ICU visit, which suggests that there are plenty of opportunities to put ACP in place.

marcosmartinezromero/iStockphoto

“Over two-thirds were seen by a doctor in the last 2 weeks. So they’re seeing doctors, but they’re still not doing advance care planning,” said Brian Block, MD, during a presentation of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. Dr. Block is with the University of California, San Francisco.

Lack of advance planning can put major road blocks in front of patient care in the ICU, as well as complicate communication between physicians and family members. The findings underscore the need to encourage conversations about end-of-life care between physicians and their patients – before the patients wind up in intensive care.

One audience member believes these conversations are already happening. Paul Yodice, MD, chairman of medicine at Saint Barnabas Medical Center in Livingston, N.J., suggested that physicians are attempting to engage older patients and family members in ACP, but many are unready to make decisions. “In my experience, it is happening much more frequently than is captured either in the medical record or in the research that we’ve been publishing. I’ve been a part of those conversations. Those individuals who are faced with those toughest of choices choose to delay making the decision or speaking about it further because it’s just too painful to consider, and they hold out hope of being the one to beat the odds, to have one more day,” said Dr. Yodice.

He called for further research to document whether ACP conversations are happening and to identify barriers to decisions and the means to overcome them. “A next good study would be to send out a respectful survey to the families of those who have lost people they love and ask: Has someone in the past year spoken with you or offered to have a discussion about end-of-life issues? We could get a better handle on [how often] the discussion is being had, and then find a solution,” said Dr. Yodice.

ACP can also be difficult for the provider, he added. Family members and patients, desperate for another treatment option, will often ask if there’s anything else that can be done. “In medicine, the answer almost always is ‘Well, we can try something else even though I know it’s not going to work.’ And people hold on to that, including us,” said Dr. Yodice.

The study analyzed data from a Medicare cohort of 1,109 patients who died during 2000-2013 and had an ICU admission within the last 30 days of their life. Ages were fairly evenly distributed, with 29% aged 65-74 years, 39% aged 75-84, and 32% aged 85 and over. Fifty-four percent were women, 26% were nonwhite, 42% had not completed high school, and 11% were in skilled nursing facilities.

About 35% had no ACP in 2000-2001, and that percentage gradually declined, to about 20% in 2012-2013 (slope, –1.6%/year; P = .009).

Seventeen percent of white participants had no ACP, compared with 51% of blacks and 49% of Hispanics. Net worth was also strongly associated with having ACP: The top quartile had 13% lacking ACP, compared with 43% of the bottom quartile.

The study found that 94% of patients who had no ACP had visited a health care provider in the past year. The average number of visits in the past year was 20, and 83% had seen a provider within the past 30 days.

Dr. Block did not declare a source of funding or potential conflicts. Dr. Yodice had no disclosures.
 

chestphysiciannews@chestnet.org

SOURCE: Block B et al. CCC48, Abstract 401.

Bias can be defined as a prejudice or a preformed inclination. Bias is reflective of one’s inherent mind set about any thing, concept, ideology, claim, product, person, or group of people. Since biases are well known to be inherent in human nature, one can fairly ask how important and how widespread are they and what are their effects?

Bias affects many fields including medicine. One example is the statin controversy. Some experts interpret existing data, which includes randomized controlled trials, to make a strong case that statins are harmful and do little good. In contrast, other qualified experts interpret precisely the same data to conclude that statins are miracle drugs that sharply diminish the mortality and morbidity from atherosclerosis. Again bias rules and leads to disagreement, controversy, and damaging public uncertainty.

A second examples in medicine – and there are many – is the current controversy over what constitutes the optimal treatment for patients with asymptomatic carotid stenosis. Some authorities believe no such patients should be treated invasively, while others hold the position that many should be. Still other experts opine that only a rare asymptomatic patient should undergo invasive treatment. All three groups use the same existing factual data to support their differing and sometimes totally opposite opinions. These contrasting views are reflected in articles in leading journals and differences among various guidelines from prestigious learned groups. The only explanation for their differing conclusions appears to be the fact that they are largely based on the bias of the authors of the articles or guidelines. Again, bias rules.

So these and many other examples exist in every phase of human endeavor. Biases are omnipresent and critically important in everything people do. They control our thinking, our opinions, our reasoning, our behavior, and most importantly, our decisions. They override most other forces that influence how we humans behave.

What can be done about this dominance of bias? The main safeguard against it is to recognize its controlling importance in all human thinking. Such recognition will help to offset the harmful effects of bias and encourage other, more laudable forces to influence behavior and actions. Logic is one such force. Even more important is objective interpretation of facts and a clear assessment of their validity.

Such objectivity may be difficult currently because of the overt bias expressed in our media and publications. If one doubts the influence of such bias, watch reports of the same event on CNN and Fox News. It is hard to believe the two sources are describing the same event. The same can be true of news reports in the New York Times and the Wall Street Journal. Bias often overrides objective reporting.

Somewhat surprisingly, even articles in our highly rated scientific journals are subject to the influences of bias. As in the lay press, scientific authors, reviewers, and editors all function under its spell.

By recognizing the importance, the dominance, and the universality of bias, individuals and groups can move toward neutralizing its divisive, damaging, and overall negative effects. Such recognition of bias will not eliminate it, but it would help to make the world a better place.

Dr. Veith is professor of surgery at New York University Langone Medical Center and Case Western Reserve University, Cleveland, as well as the William J. von Liebig Chair in Vascular Surgery at the Cleveland Clinic Foundation.

Bias can be defined as a prejudice or a preformed inclination. Bias is reflective of one’s inherent mind set about any thing, concept, ideology, claim, product, person, or group of people. Since biases are well known to be inherent in human nature, one can fairly ask how important and how widespread are they and what are their effects?

Bias affects many fields including medicine. One example is the statin controversy. Some experts interpret existing data, which includes randomized controlled trials, to make a strong case that statins are harmful and do little good. In contrast, other qualified experts interpret precisely the same data to conclude that statins are miracle drugs that sharply diminish the mortality and morbidity from atherosclerosis. Again bias rules and leads to disagreement, controversy, and damaging public uncertainty.

A second examples in medicine – and there are many – is the current controversy over what constitutes the optimal treatment for patients with asymptomatic carotid stenosis. Some authorities believe no such patients should be treated invasively, while others hold the position that many should be. Still other experts opine that only a rare asymptomatic patient should undergo invasive treatment. All three groups use the same existing factual data to support their differing and sometimes totally opposite opinions. These contrasting views are reflected in articles in leading journals and differences among various guidelines from prestigious learned groups. The only explanation for their differing conclusions appears to be the fact that they are largely based on the bias of the authors of the articles or guidelines. Again, bias rules.

So these and many other examples exist in every phase of human endeavor. Biases are omnipresent and critically important in everything people do. They control our thinking, our opinions, our reasoning, our behavior, and most importantly, our decisions. They override most other forces that influence how we humans behave.

What can be done about this dominance of bias? The main safeguard against it is to recognize its controlling importance in all human thinking. Such recognition will help to offset the harmful effects of bias and encourage other, more laudable forces to influence behavior and actions. Logic is one such force. Even more important is objective interpretation of facts and a clear assessment of their validity.

Such objectivity may be difficult currently because of the overt bias expressed in our media and publications. If one doubts the influence of such bias, watch reports of the same event on CNN and Fox News. It is hard to believe the two sources are describing the same event. The same can be true of news reports in the New York Times and the Wall Street Journal. Bias often overrides objective reporting.

Somewhat surprisingly, even articles in our highly rated scientific journals are subject to the influences of bias. As in the lay press, scientific authors, reviewers, and editors all function under its spell.

By recognizing the importance, the dominance, and the universality of bias, individuals and groups can move toward neutralizing its divisive, damaging, and overall negative effects. Such recognition of bias will not eliminate it, but it would help to make the world a better place.

Dr. Veith is professor of surgery at New York University Langone Medical Center and Case Western Reserve University, Cleveland, as well as the William J. von Liebig Chair in Vascular Surgery at the Cleveland Clinic Foundation.

Bias can be defined as a prejudice or a preformed inclination. Bias is reflective of one’s inherent mind set about any thing, concept, ideology, claim, product, person, or group of people. Since biases are well known to be inherent in human nature, one can fairly ask how important and how widespread are they and what are their effects?

Bias affects many fields including medicine. One example is the statin controversy. Some experts interpret existing data, which includes randomized controlled trials, to make a strong case that statins are harmful and do little good. In contrast, other qualified experts interpret precisely the same data to conclude that statins are miracle drugs that sharply diminish the mortality and morbidity from atherosclerosis. Again bias rules and leads to disagreement, controversy, and damaging public uncertainty.

A second examples in medicine – and there are many – is the current controversy over what constitutes the optimal treatment for patients with asymptomatic carotid stenosis. Some authorities believe no such patients should be treated invasively, while others hold the position that many should be. Still other experts opine that only a rare asymptomatic patient should undergo invasive treatment. All three groups use the same existing factual data to support their differing and sometimes totally opposite opinions. These contrasting views are reflected in articles in leading journals and differences among various guidelines from prestigious learned groups. The only explanation for their differing conclusions appears to be the fact that they are largely based on the bias of the authors of the articles or guidelines. Again, bias rules.

So these and many other examples exist in every phase of human endeavor. Biases are omnipresent and critically important in everything people do. They control our thinking, our opinions, our reasoning, our behavior, and most importantly, our decisions. They override most other forces that influence how we humans behave.

What can be done about this dominance of bias? The main safeguard against it is to recognize its controlling importance in all human thinking. Such recognition will help to offset the harmful effects of bias and encourage other, more laudable forces to influence behavior and actions. Logic is one such force. Even more important is objective interpretation of facts and a clear assessment of their validity.

Such objectivity may be difficult currently because of the overt bias expressed in our media and publications. If one doubts the influence of such bias, watch reports of the same event on CNN and Fox News. It is hard to believe the two sources are describing the same event. The same can be true of news reports in the New York Times and the Wall Street Journal. Bias often overrides objective reporting.

Somewhat surprisingly, even articles in our highly rated scientific journals are subject to the influences of bias. As in the lay press, scientific authors, reviewers, and editors all function under its spell.

By recognizing the importance, the dominance, and the universality of bias, individuals and groups can move toward neutralizing its divisive, damaging, and overall negative effects. Such recognition of bias will not eliminate it, but it would help to make the world a better place.

Dr. Veith is professor of surgery at New York University Langone Medical Center and Case Western Reserve University, Cleveland, as well as the William J. von Liebig Chair in Vascular Surgery at the Cleveland Clinic Foundation.

 

SAN FRANCISCO – Dual targeting of the androgen signaling axis in metastatic hormone-sensitive prostate cancer improves outcomes and is well tolerated, according to results of the phase 3 ARCHES trial reported at the 2019 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.

“Androgen-deprivation therapy [ADT] has been the mainstay of therapy for men who present with metastatic disease for many years. But generally, progression to castration-resistant diseases is observed within approximately 3 years,” said lead investigator Andrew J. Armstrong, MD, a professor of medicine in medical oncology at Duke University, Durham, N.C.

“Thus the advent of improving outcomes with the [additional] use of early docetaxel, abiraterone, and now radiation to the primary in the face of oligometastatic disease has been shown to improve survival,” he added. “However, the most recent studies have really not studied the sequential use of docetaxel and have largely excluded patients who had had prior docetaxel chemotherapy in the hormone-sensitive setting.”

The investigators in the ARCHES trial (NCT02677896) randomized 1,150 men with metastatic hormone-sensitive prostate cancer to enzalutamide (Xtandi) plus ADT or placebo plus ADT.

With a median follow-up of 14.4 months, radiographic progression-free survival – the trial’s primary endpoint – was prolonged in the enzalutamide arm. Risk of progression or death was reduced by a relative 61% with enzalutamide versus placebo. There were also significant relative reductions in risks of other important outcomes such as time to prostate-specific antigen (PSA) progression (81% reduction), time to new antineoplastic therapy (72% reduction), and time to castration resistance (72% reduction).

Meanwhile, the enzalutamide group had somewhat more fatigue, hot flashes, and hypertension, but most of these events were grade 1 or 2. Rates of adverse events leading to treatment withdrawal were similar and low.

“Following the success of this study, all patients in the placebo group will be offered participation in an open-label extension protocol where they’ll be offered enzalutamide and the opportunity to receive a clinically beneficial treatment,” Dr. Armstrong reported.
 

Ready for prime time?

The ARCHES findings are probably not yet sufficient to be implemented in real-world practice, according to invited discussant Ian D. Davis, MBBS, PhD, a professor at Monash University, Melbourne.

The condition studied in the trial – metastatic hormone-sensitive prostate cancer – certainly needs treatment, but it is unclear whether radiographic progression-free survival is a meaningful endpoint, he said. “We know in the CRPC [castration-resistant prostate cancer] setting for enzalutamide in the PREVAIL study, radiographic progression-free survival was correlated with overall survival, but we haven’t actually proven that yet in the CSPC [castration-sensitive prostate cancer] setting.”

Toxicity was acceptable, but information about the efficacy of subsequent treatment is lacking. “This is where progression-free survival 2 [PFS2] information would be useful if we had it,” Dr. Davis noted. Cost-effectiveness in terms of overall survival is likewise still unknown.

“Cautiously, and I’m conscious of my conflict of interest here because I’m doing a similar trial, I’d say that the ARCHES trial should probably not yet change practice,” he said. However, he qualified that statement by pointing to recently announced results from the phase 3 TITAN trial (NCT02489318) of apalutamide (Erleada), showing significant radiographic progression-free survival and overall survival benefit in this patient population. “So we await those data with interest.”

The first interim analysis of the enzalutamide trial he is cochairing, ANZUP ENZAMET (NCT02446405), is imminent, according to Dr. Davis. “The differences here are the primary endpoint of ENZAMET is overall survival and there was an early amendment to allow concurrent docetaxel, so a significant proportion of patients on this study will have received concurrent docetaxel with enzalutamide or ADT,” he noted.

 

Study details

Men enrolled in ARCHES were allowed to have received prior ADT for up to 3 months or, if they had received docetaxel, for up to 6 months, Dr. Armstrong noted at the symposium.

About two-thirds each had high disease volume and had distant metastasis at their initial diagnosis. Overall, median duration of prior ADT was 1.6 months.

Radiographic progression-free survival was not reached with enzalutamide versus 19.45 months with placebo (hazard ratio, 0.39; P less than .0001). Corresponding 12-month rates were 84% and 64%. Findings were essentially the same across diverse subgroups, including among the 18% of patients who had received prior docetaxel (HR, 0.53).

Median time to PSA progression – typically one of the first indications of castration resistance – was not reached in either group, but the 12-month rate was 91% with enzalutamide versus 63% with placebo (HR, 0.19; P less than .0001), Dr. Armstrong reported. Median time to castration resistance was not reached with enzalutamide versus 13.9 months with placebo (HR, 0.28; P less than .0001).

There also were significant differences in favor of enzalutamide on the rate of achievement of undetectable PSA (68.1% vs. 17.6%; P less than .0001), the objective response rate (83.1% vs. 63.7%; P less than .0001), and the time to initiation of new antineoplastic therapy (not reached vs. 30.19 months; HR, 0.28; P less than .0001).

Quality of life was very high in both groups at study baseline and remained similarly so during follow-up. An interim analysis showed overall survival had not been reached in either group, although there was a nonsignificant trend favoring enzalutamide.

Safety was much the same, with the enzalutamide and placebo groups having similar rates of grade 3 or worse adverse events (24.3% vs. 25.6%), as well as similar rates of adverse events leading to treatment withdrawal (7.2% vs. 5.2%) and death (2.4% vs. 1.7%).

In terms of adverse events of special interest, the groups were comparable on rates of grade 3 or 4 convulsion, ischemic heart disease, falls, and fractures.

Dr. Armstrong disclosed that he has a consulting or advisory role with, receives research funding (institutional) from, and receives travel, accommodations, and/or expenses from Astellas – among other disclosures. The trial was sponsored by Astellas.

SOURCE: Armstrong AJ et al. GUCS 2019, Abstract 687.

 

SAN FRANCISCO – Dual targeting of the androgen signaling axis in metastatic hormone-sensitive prostate cancer improves outcomes and is well tolerated, according to results of the phase 3 ARCHES trial reported at the 2019 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.

“Androgen-deprivation therapy [ADT] has been the mainstay of therapy for men who present with metastatic disease for many years. But generally, progression to castration-resistant diseases is observed within approximately 3 years,” said lead investigator Andrew J. Armstrong, MD, a professor of medicine in medical oncology at Duke University, Durham, N.C.

“Thus the advent of improving outcomes with the [additional] use of early docetaxel, abiraterone, and now radiation to the primary in the face of oligometastatic disease has been shown to improve survival,” he added. “However, the most recent studies have really not studied the sequential use of docetaxel and have largely excluded patients who had had prior docetaxel chemotherapy in the hormone-sensitive setting.”

The investigators in the ARCHES trial (NCT02677896) randomized 1,150 men with metastatic hormone-sensitive prostate cancer to enzalutamide (Xtandi) plus ADT or placebo plus ADT.

With a median follow-up of 14.4 months, radiographic progression-free survival – the trial’s primary endpoint – was prolonged in the enzalutamide arm. Risk of progression or death was reduced by a relative 61% with enzalutamide versus placebo. There were also significant relative reductions in risks of other important outcomes such as time to prostate-specific antigen (PSA) progression (81% reduction), time to new antineoplastic therapy (72% reduction), and time to castration resistance (72% reduction).

Meanwhile, the enzalutamide group had somewhat more fatigue, hot flashes, and hypertension, but most of these events were grade 1 or 2. Rates of adverse events leading to treatment withdrawal were similar and low.

“Following the success of this study, all patients in the placebo group will be offered participation in an open-label extension protocol where they’ll be offered enzalutamide and the opportunity to receive a clinically beneficial treatment,” Dr. Armstrong reported.
 

Ready for prime time?

The ARCHES findings are probably not yet sufficient to be implemented in real-world practice, according to invited discussant Ian D. Davis, MBBS, PhD, a professor at Monash University, Melbourne.

The condition studied in the trial – metastatic hormone-sensitive prostate cancer – certainly needs treatment, but it is unclear whether radiographic progression-free survival is a meaningful endpoint, he said. “We know in the CRPC [castration-resistant prostate cancer] setting for enzalutamide in the PREVAIL study, radiographic progression-free survival was correlated with overall survival, but we haven’t actually proven that yet in the CSPC [castration-sensitive prostate cancer] setting.”

Toxicity was acceptable, but information about the efficacy of subsequent treatment is lacking. “This is where progression-free survival 2 [PFS2] information would be useful if we had it,” Dr. Davis noted. Cost-effectiveness in terms of overall survival is likewise still unknown.

“Cautiously, and I’m conscious of my conflict of interest here because I’m doing a similar trial, I’d say that the ARCHES trial should probably not yet change practice,” he said. However, he qualified that statement by pointing to recently announced results from the phase 3 TITAN trial (NCT02489318) of apalutamide (Erleada), showing significant radiographic progression-free survival and overall survival benefit in this patient population. “So we await those data with interest.”

The first interim analysis of the enzalutamide trial he is cochairing, ANZUP ENZAMET (NCT02446405), is imminent, according to Dr. Davis. “The differences here are the primary endpoint of ENZAMET is overall survival and there was an early amendment to allow concurrent docetaxel, so a significant proportion of patients on this study will have received concurrent docetaxel with enzalutamide or ADT,” he noted.

 

Study details

Men enrolled in ARCHES were allowed to have received prior ADT for up to 3 months or, if they had received docetaxel, for up to 6 months, Dr. Armstrong noted at the symposium.

About two-thirds each had high disease volume and had distant metastasis at their initial diagnosis. Overall, median duration of prior ADT was 1.6 months.

Radiographic progression-free survival was not reached with enzalutamide versus 19.45 months with placebo (hazard ratio, 0.39; P less than .0001). Corresponding 12-month rates were 84% and 64%. Findings were essentially the same across diverse subgroups, including among the 18% of patients who had received prior docetaxel (HR, 0.53).

Median time to PSA progression – typically one of the first indications of castration resistance – was not reached in either group, but the 12-month rate was 91% with enzalutamide versus 63% with placebo (HR, 0.19; P less than .0001), Dr. Armstrong reported. Median time to castration resistance was not reached with enzalutamide versus 13.9 months with placebo (HR, 0.28; P less than .0001).

There also were significant differences in favor of enzalutamide on the rate of achievement of undetectable PSA (68.1% vs. 17.6%; P less than .0001), the objective response rate (83.1% vs. 63.7%; P less than .0001), and the time to initiation of new antineoplastic therapy (not reached vs. 30.19 months; HR, 0.28; P less than .0001).

Quality of life was very high in both groups at study baseline and remained similarly so during follow-up. An interim analysis showed overall survival had not been reached in either group, although there was a nonsignificant trend favoring enzalutamide.

Safety was much the same, with the enzalutamide and placebo groups having similar rates of grade 3 or worse adverse events (24.3% vs. 25.6%), as well as similar rates of adverse events leading to treatment withdrawal (7.2% vs. 5.2%) and death (2.4% vs. 1.7%).

In terms of adverse events of special interest, the groups were comparable on rates of grade 3 or 4 convulsion, ischemic heart disease, falls, and fractures.

Dr. Armstrong disclosed that he has a consulting or advisory role with, receives research funding (institutional) from, and receives travel, accommodations, and/or expenses from Astellas – among other disclosures. The trial was sponsored by Astellas.

SOURCE: Armstrong AJ et al. GUCS 2019, Abstract 687.

 

SAN FRANCISCO – Dual targeting of the androgen signaling axis in metastatic hormone-sensitive prostate cancer improves outcomes and is well tolerated, according to results of the phase 3 ARCHES trial reported at the 2019 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.

“Androgen-deprivation therapy [ADT] has been the mainstay of therapy for men who present with metastatic disease for many years. But generally, progression to castration-resistant diseases is observed within approximately 3 years,” said lead investigator Andrew J. Armstrong, MD, a professor of medicine in medical oncology at Duke University, Durham, N.C.

“Thus the advent of improving outcomes with the [additional] use of early docetaxel, abiraterone, and now radiation to the primary in the face of oligometastatic disease has been shown to improve survival,” he added. “However, the most recent studies have really not studied the sequential use of docetaxel and have largely excluded patients who had had prior docetaxel chemotherapy in the hormone-sensitive setting.”

The investigators in the ARCHES trial (NCT02677896) randomized 1,150 men with metastatic hormone-sensitive prostate cancer to enzalutamide (Xtandi) plus ADT or placebo plus ADT.

With a median follow-up of 14.4 months, radiographic progression-free survival – the trial’s primary endpoint – was prolonged in the enzalutamide arm. Risk of progression or death was reduced by a relative 61% with enzalutamide versus placebo. There were also significant relative reductions in risks of other important outcomes such as time to prostate-specific antigen (PSA) progression (81% reduction), time to new antineoplastic therapy (72% reduction), and time to castration resistance (72% reduction).

Meanwhile, the enzalutamide group had somewhat more fatigue, hot flashes, and hypertension, but most of these events were grade 1 or 2. Rates of adverse events leading to treatment withdrawal were similar and low.

“Following the success of this study, all patients in the placebo group will be offered participation in an open-label extension protocol where they’ll be offered enzalutamide and the opportunity to receive a clinically beneficial treatment,” Dr. Armstrong reported.
 

Ready for prime time?

The ARCHES findings are probably not yet sufficient to be implemented in real-world practice, according to invited discussant Ian D. Davis, MBBS, PhD, a professor at Monash University, Melbourne.

The condition studied in the trial – metastatic hormone-sensitive prostate cancer – certainly needs treatment, but it is unclear whether radiographic progression-free survival is a meaningful endpoint, he said. “We know in the CRPC [castration-resistant prostate cancer] setting for enzalutamide in the PREVAIL study, radiographic progression-free survival was correlated with overall survival, but we haven’t actually proven that yet in the CSPC [castration-sensitive prostate cancer] setting.”

Toxicity was acceptable, but information about the efficacy of subsequent treatment is lacking. “This is where progression-free survival 2 [PFS2] information would be useful if we had it,” Dr. Davis noted. Cost-effectiveness in terms of overall survival is likewise still unknown.

“Cautiously, and I’m conscious of my conflict of interest here because I’m doing a similar trial, I’d say that the ARCHES trial should probably not yet change practice,” he said. However, he qualified that statement by pointing to recently announced results from the phase 3 TITAN trial (NCT02489318) of apalutamide (Erleada), showing significant radiographic progression-free survival and overall survival benefit in this patient population. “So we await those data with interest.”

The first interim analysis of the enzalutamide trial he is cochairing, ANZUP ENZAMET (NCT02446405), is imminent, according to Dr. Davis. “The differences here are the primary endpoint of ENZAMET is overall survival and there was an early amendment to allow concurrent docetaxel, so a significant proportion of patients on this study will have received concurrent docetaxel with enzalutamide or ADT,” he noted.

 

Study details

Men enrolled in ARCHES were allowed to have received prior ADT for up to 3 months or, if they had received docetaxel, for up to 6 months, Dr. Armstrong noted at the symposium.

About two-thirds each had high disease volume and had distant metastasis at their initial diagnosis. Overall, median duration of prior ADT was 1.6 months.

Radiographic progression-free survival was not reached with enzalutamide versus 19.45 months with placebo (hazard ratio, 0.39; P less than .0001). Corresponding 12-month rates were 84% and 64%. Findings were essentially the same across diverse subgroups, including among the 18% of patients who had received prior docetaxel (HR, 0.53).

Median time to PSA progression – typically one of the first indications of castration resistance – was not reached in either group, but the 12-month rate was 91% with enzalutamide versus 63% with placebo (HR, 0.19; P less than .0001), Dr. Armstrong reported. Median time to castration resistance was not reached with enzalutamide versus 13.9 months with placebo (HR, 0.28; P less than .0001).

There also were significant differences in favor of enzalutamide on the rate of achievement of undetectable PSA (68.1% vs. 17.6%; P less than .0001), the objective response rate (83.1% vs. 63.7%; P less than .0001), and the time to initiation of new antineoplastic therapy (not reached vs. 30.19 months; HR, 0.28; P less than .0001).

Quality of life was very high in both groups at study baseline and remained similarly so during follow-up. An interim analysis showed overall survival had not been reached in either group, although there was a nonsignificant trend favoring enzalutamide.

Safety was much the same, with the enzalutamide and placebo groups having similar rates of grade 3 or worse adverse events (24.3% vs. 25.6%), as well as similar rates of adverse events leading to treatment withdrawal (7.2% vs. 5.2%) and death (2.4% vs. 1.7%).

In terms of adverse events of special interest, the groups were comparable on rates of grade 3 or 4 convulsion, ischemic heart disease, falls, and fractures.

Dr. Armstrong disclosed that he has a consulting or advisory role with, receives research funding (institutional) from, and receives travel, accommodations, and/or expenses from Astellas – among other disclosures. The trial was sponsored by Astellas.

SOURCE: Armstrong AJ et al. GUCS 2019, Abstract 687.

 

The 2018 State of Hospital Medicine (SoHM) Report provides indispensable data about the scope of clinical services routinely provided by adult and pediatric hospitalists. This year’s SoHM report reveals that a growing number of Hospital Medicine Groups (HMGs) serving adults are involved in roles beyond the inpatient medical wards, including various surgical comanagement programs, outpatient care, and post-acute care services.

The survey also compares services provided by academic and nonacademic HMGs, which remain markedly different in some areas. As the landscape of health care continues to evolve, hospitalists transform their scope of services to meet the needs of the institutions and communities they serve.

In the previous three SoHM reports, it was well established that more than 87% of adult hospital medicine groups play some role in comanaging surgical patients. In this year’s SoHM report, that role was further stratified to capture the various subspecialties represented, and to identify whether the hospitalists generally served as admitting/attending physician or consultant.

Hospitalists’ roles in comanagement are most prominent for care of orthopedic and general surgery patients, but more than 50% of surveyed HMGs reported being involved in comanagement in some capacity with neurosurgery, obstetrics, and cardiovascular surgery. Additionally, almost 95% of surveyed adult HMGs reported that they provided comanagement services for at least one other surgical specialty that was not listed in the survey.

The report also displays comanagement services provided to various medical subspecialties, including neurology, GI/liver, oncology, and more. Of the medical subspecialties represented, adult HMGs comanaged GI/liver (98.2%) and oncology (97.7%) services more often than others.

Interestingly, more HMGs are providing care for patients beyond the walls of the hospital. In the 2018 SoHM report, over 17% of surveyed HMG respondents reported providing care in an outpatient setting, representing an increase of 6.5 percentage points over 2016. Most strikingly, from 2016 to 2018, there was a 12 percentage point increase in adult HMGs reporting services provided to post-acute care facilities (from 13.1% to 24.8%).

These trends were most notable in the Midwest region where nearly 28% of HMGs provide patient care in an outpatient setting and up to 34% in post-acute care facilities. In part, this trend may result from the increased emphasis on improving transitions of care, by providing prehospital preoperative services, postdischarge follow-up encounters, or offering posthospitalization extensivist care.

Within the hospital itself, there remain striking differences in certain services provided by academic and nonacademic HMGs serving adults. Nonacademic HMGs are far more likely to cover patients in an ICU than their academic counterparts (72.0% vs. 34.3%). In contrast, academic hospitalist groups were significantly more inclined to perform procedures. However, the report also showed that there was an overall downtrend of percentage of HMGs that cover patients in an ICU or perform procedures.

As the scope of hospitalist services continues to change over time, should there be concern for scope creep? It depends on how one might view the change. As health care becomes ever more complex, high-functioning HMGs are needed to navigate it, both within and beyond the hospital. Some might consider scope evolution to be a reflection of hospitalists being recognized for their ability to provide high-quality, efficient, and comprehensive care. Hospital medicine groups will likely continue to evolve to meet the needs of an ever-changing health care environment.

Dr. Kurian is chief of the academic division of hospital medicine at Northwell Health in New York. She is a member of the SHM Practice Analysis Committee.

 

The 2018 State of Hospital Medicine (SoHM) Report provides indispensable data about the scope of clinical services routinely provided by adult and pediatric hospitalists. This year’s SoHM report reveals that a growing number of Hospital Medicine Groups (HMGs) serving adults are involved in roles beyond the inpatient medical wards, including various surgical comanagement programs, outpatient care, and post-acute care services.

The survey also compares services provided by academic and nonacademic HMGs, which remain markedly different in some areas. As the landscape of health care continues to evolve, hospitalists transform their scope of services to meet the needs of the institutions and communities they serve.

In the previous three SoHM reports, it was well established that more than 87% of adult hospital medicine groups play some role in comanaging surgical patients. In this year’s SoHM report, that role was further stratified to capture the various subspecialties represented, and to identify whether the hospitalists generally served as admitting/attending physician or consultant.

Hospitalists’ roles in comanagement are most prominent for care of orthopedic and general surgery patients, but more than 50% of surveyed HMGs reported being involved in comanagement in some capacity with neurosurgery, obstetrics, and cardiovascular surgery. Additionally, almost 95% of surveyed adult HMGs reported that they provided comanagement services for at least one other surgical specialty that was not listed in the survey.

The report also displays comanagement services provided to various medical subspecialties, including neurology, GI/liver, oncology, and more. Of the medical subspecialties represented, adult HMGs comanaged GI/liver (98.2%) and oncology (97.7%) services more often than others.

Interestingly, more HMGs are providing care for patients beyond the walls of the hospital. In the 2018 SoHM report, over 17% of surveyed HMG respondents reported providing care in an outpatient setting, representing an increase of 6.5 percentage points over 2016. Most strikingly, from 2016 to 2018, there was a 12 percentage point increase in adult HMGs reporting services provided to post-acute care facilities (from 13.1% to 24.8%).

These trends were most notable in the Midwest region where nearly 28% of HMGs provide patient care in an outpatient setting and up to 34% in post-acute care facilities. In part, this trend may result from the increased emphasis on improving transitions of care, by providing prehospital preoperative services, postdischarge follow-up encounters, or offering posthospitalization extensivist care.

Within the hospital itself, there remain striking differences in certain services provided by academic and nonacademic HMGs serving adults. Nonacademic HMGs are far more likely to cover patients in an ICU than their academic counterparts (72.0% vs. 34.3%). In contrast, academic hospitalist groups were significantly more inclined to perform procedures. However, the report also showed that there was an overall downtrend of percentage of HMGs that cover patients in an ICU or perform procedures.

As the scope of hospitalist services continues to change over time, should there be concern for scope creep? It depends on how one might view the change. As health care becomes ever more complex, high-functioning HMGs are needed to navigate it, both within and beyond the hospital. Some might consider scope evolution to be a reflection of hospitalists being recognized for their ability to provide high-quality, efficient, and comprehensive care. Hospital medicine groups will likely continue to evolve to meet the needs of an ever-changing health care environment.

Dr. Kurian is chief of the academic division of hospital medicine at Northwell Health in New York. She is a member of the SHM Practice Analysis Committee.

 

The 2018 State of Hospital Medicine (SoHM) Report provides indispensable data about the scope of clinical services routinely provided by adult and pediatric hospitalists. This year’s SoHM report reveals that a growing number of Hospital Medicine Groups (HMGs) serving adults are involved in roles beyond the inpatient medical wards, including various surgical comanagement programs, outpatient care, and post-acute care services.

The survey also compares services provided by academic and nonacademic HMGs, which remain markedly different in some areas. As the landscape of health care continues to evolve, hospitalists transform their scope of services to meet the needs of the institutions and communities they serve.

In the previous three SoHM reports, it was well established that more than 87% of adult hospital medicine groups play some role in comanaging surgical patients. In this year’s SoHM report, that role was further stratified to capture the various subspecialties represented, and to identify whether the hospitalists generally served as admitting/attending physician or consultant.

Hospitalists’ roles in comanagement are most prominent for care of orthopedic and general surgery patients, but more than 50% of surveyed HMGs reported being involved in comanagement in some capacity with neurosurgery, obstetrics, and cardiovascular surgery. Additionally, almost 95% of surveyed adult HMGs reported that they provided comanagement services for at least one other surgical specialty that was not listed in the survey.

The report also displays comanagement services provided to various medical subspecialties, including neurology, GI/liver, oncology, and more. Of the medical subspecialties represented, adult HMGs comanaged GI/liver (98.2%) and oncology (97.7%) services more often than others.

Interestingly, more HMGs are providing care for patients beyond the walls of the hospital. In the 2018 SoHM report, over 17% of surveyed HMG respondents reported providing care in an outpatient setting, representing an increase of 6.5 percentage points over 2016. Most strikingly, from 2016 to 2018, there was a 12 percentage point increase in adult HMGs reporting services provided to post-acute care facilities (from 13.1% to 24.8%).

These trends were most notable in the Midwest region where nearly 28% of HMGs provide patient care in an outpatient setting and up to 34% in post-acute care facilities. In part, this trend may result from the increased emphasis on improving transitions of care, by providing prehospital preoperative services, postdischarge follow-up encounters, or offering posthospitalization extensivist care.

Within the hospital itself, there remain striking differences in certain services provided by academic and nonacademic HMGs serving adults. Nonacademic HMGs are far more likely to cover patients in an ICU than their academic counterparts (72.0% vs. 34.3%). In contrast, academic hospitalist groups were significantly more inclined to perform procedures. However, the report also showed that there was an overall downtrend of percentage of HMGs that cover patients in an ICU or perform procedures.

As the scope of hospitalist services continues to change over time, should there be concern for scope creep? It depends on how one might view the change. As health care becomes ever more complex, high-functioning HMGs are needed to navigate it, both within and beyond the hospital. Some might consider scope evolution to be a reflection of hospitalists being recognized for their ability to provide high-quality, efficient, and comprehensive care. Hospital medicine groups will likely continue to evolve to meet the needs of an ever-changing health care environment.

Dr. Kurian is chief of the academic division of hospital medicine at Northwell Health in New York. She is a member of the SHM Practice Analysis Committee.