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VIDEO: Rivaroxaban plus aspirin cut cardiovascular events in stable patients

Low-dose rivaroxaban benefits despite increased bleeding
Article Type
Changed
Tue, 07/21/2020 - 14:18

– Combined treatment with a very low dosage of the anticoagulant rivaroxaban plus low-dose aspirin produced significant cuts in major adverse coronary, cerebral, and peripheral artery disease events with just a modest rise in major bleeding events in patients with stable disease in the COMPASS pivotal, randomized trial with more than 27,000 patients.

The benefits from the rivaroxaban plus aspirin regimen included a statistically significant 24% relative risk reduction in the study’s primary, combined endpoint, and a significant 18% relative risk reduction in all-cause death compared with a standard regimen of aspirin only, John W. Eikelboom, MD, said at the annual congress of the European Society of Cardiology. In addition, analysis of the net clinical benefit from treatment that took into account both the major adverse cardiovascular events prevented and major bleeding events induced, showed that the rivaroxaban-plus-aspirin regimen cut these by a statistically significant 20%, compared with aspirin alone.

Other notable benefits documented by the findings included a statistically significant 42% relative risk reduction for stroke and a statistically significant 46% relative risk reduction in the incidence of major adverse limb events among the roughly one-quarter of enrolled patients who entered the study with evidence of peripheral artery disease.

These risk reductions are similar in magnitude to the secondary-prevention benefits produced by controlling hypertension or dyslipidemia, noted Dr. Eikelboom, a researcher at McMaster University in Hamilton, Ont. “In the future, rivaroxaban will take its place among the other foundational treatments for long-term, secondary prevention,” he predicted in a video interview.

The COMPASS trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease,” commented Eugene Braunwald, MD, designated discussant for Dr. Eikelboom’s report. The results are “an important step for thrombocardiology,” said Dr. Braunwald, professor of medicine at Harvard Medical School in Boston.

Concurrently with Dr. Eikelboom’s report the results appeared in an article published online (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMoa1709118). This publication also include an editorial by Dr. Braunwald (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMe1710241).

Mitchel L. Zoler/Frontline Medical News
Dr. Eugene Braunwald


The Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS) trial enrolled 27,395 patients with stable coronary, carotid, or peripheral artery disease, or a combination of two or more of these, at 602 centers in 33 countries. About 90% of enrolled patients had coronary artery disease and 27% had peripheral artery disease. The enrolled patients averaged 68 year old and were an average of 7 years removed from their index arterial event. Randomization assigned patients to receive 2.5 mg rivaroxaban (Xarelto) twice daily plus 100 mg aspirin daily, 5 mg rivaroxaban twice daily, or 100 mg aspirin once daily. The trial stopped early, after an average follow-up of 23 months, because of the overwhelming benefit seen for the rivaroxaban plus aspirin combination. The rivaroxaban-monotherapy arm failed to show any statistically significant benefits, compared with the aspirin-monotherapy control group.

The study’s primary endpoint – the combined rate of cardiovascular disease death, nonfatal stroke, and nonfatal MI – occurred in 4.1% of patients in the rivaroxaban-plus-aspirin group and in 5.4% of patients on aspirin alone. The rate of major bleeding events was 3.1% among patients on rivaroxaban plus aspirin and 1.9% in those who received aspirin only, a 51% relative increase among patients on the dual regimen, but the results showed no statistically significant increase in the rates of fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.

Sonia Anand, MD, a colleague of Dr. Eikelboom’s at McMaster, presented a separate set of analyses that focused on the 7,470 enrolled patients who had been diagnosed at enrollment with peripheral artery disease. In this subgroup, the rivaroxaban-plus-aspirin regimen produced a statistically significant 28% relative risk reduction in the rate of the primary endpoint, compared with the aspirin control group. The dual regimen also produced a statistically significant 46% relative risk reduction in major adverse limb events and a significant 70% relative reduction in the incidence of major lower-extremity amputations, reported Dr. Anand, professor of medicine and director of the vascular medicine clinic at McMaster.
Mitchel L. Zoler/Frontline Medical News
Dr. Sonia Anand


The COMPASS findings follow a 2012 published report from the ATLAS ACS 2-TIMI 51 trial showing that treatment with the same low-dose rivaroxaban regimen plus aspirin and a thienopyridine (clopidogrel or ticlopidine) reduced the same combined triple endpoint by a statistically significant 16%, compared with aspirin and a thienopyridine alone, in patients with a recent acute coronary syndrome event (N Engl J Med. 2012 Jan 5;366[1]:9-19). Despite this evidence, the Food and Drug Administration never approved the 2.5-mg formulation of rivaroxaban, nor did it approve marketing of rivaroxaban for this acute coronary syndrome population. This decision may have been driven in part by a problem with incomplete follow-up of several of the enrolled patients.

The COMPASS results were “very consistent” with the ATLAS ACS 2-TIMI 51 results. noted Dr. Eikelboom. “I think it’s time to look at these two trials in combination,” he suggested. Availability of the 2.5-mg rivaroxaban formulation used in both trials would allow “a treatment strategy that could start early after an acute coronary syndrome event and then extend long term,” he said.

COMPASS was sponsored by Bayer, which markets rivaroxaban (Xarelto). Dr. Eikelboom has received research support from Bayer and also from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Janssen, Pfizer, Portola, and Sanofi. Dr. Anand has received speaking honoraria from several drug compnies. Dr. Braunwald had no disclosures.

 

 

 

 

Body

 

The key message from COMPASS was that, although adding a very low dosage of rivaroxaban to aspirin in patients with stable coronary or peripheral artery disease resulted in a clear increase in major bleeding events, patients received an overall net beneficial effect from the combined regimen. The finding that clinches the net benefit from the rivaroxaban plus aspirin combination, compared with aspirin alone, was that the combined regimen produced a statistically significant relative risk reduction of 18% for all-cause mortality. This finding reinforces the idea that the primary outcome was beneficial despite an increase in major bleeding events.

The finding that rivaroxaban plus aspirin produced benefit with a modest increase in bleeding risk in patients with peripheral artery disease (PAD) is especially important because PAD is really difficult to treat. Very few interventions have previously been proven to have a beneficial effect for patients with PAD. It’s very important to find an intervention that can reduce critical limb ischemia events in addition to reducing coronary events, stroke, and overall mortality.

The very low dosage of rivaroxaban used in COMPASS, 2.5 mg twice daily, seems to be a very important part of the study’s design. This dosage appeared to hit the sweet spot of being large enough to reduce events but with a gentle enough anticoagulation effect to avoid a significant increase in fatal, intracerebral, or critical organ bleeds. However, the patients enrolled in COMPASS, like most patients who enter trials, were generally at a lower risk for bleeding complications than we usually see in routine practice in patients with stable coronary or peripheral artery disease. Presuming that the Food and Drug Administration will soon approve the 2.5-mg formulation of rivaroxaban used in COMPASS, clinicians will need to be careful using this regimen on patients at increased risk for bleeding, such as frail or elderly patients with a history of bleeding events or taking other treatments that could increase bleeding risk, such as nonsteroidal anti-inflammatory drugs. In general, clinicians are wary of using treatments that increase bleeding risk, and so they may hesitate to use this combination of rivaroxaban plus aspirin in patients with a high bleeding risk.

The success of the approach used in COMPASS became possible with the introduction of the new oral anticoagulant drugs. Now that this class of agents has been available for a few years, clinicians have grown increasingly comfortable with them, compared with warfarin. When the new oral anticoagulants first came out, many considered them similar to warfarin. Today, there is a better appreciation that these drugs are distinct from warfarin by really causing fewer bleeding complications.

Dr. Christopher B. Granger

 

Christopher B. Granger, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research support from Bayer and from other drugs companies that market new oral anticoagulants. He made these comments in an interview.

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The key message from COMPASS was that, although adding a very low dosage of rivaroxaban to aspirin in patients with stable coronary or peripheral artery disease resulted in a clear increase in major bleeding events, patients received an overall net beneficial effect from the combined regimen. The finding that clinches the net benefit from the rivaroxaban plus aspirin combination, compared with aspirin alone, was that the combined regimen produced a statistically significant relative risk reduction of 18% for all-cause mortality. This finding reinforces the idea that the primary outcome was beneficial despite an increase in major bleeding events.

The finding that rivaroxaban plus aspirin produced benefit with a modest increase in bleeding risk in patients with peripheral artery disease (PAD) is especially important because PAD is really difficult to treat. Very few interventions have previously been proven to have a beneficial effect for patients with PAD. It’s very important to find an intervention that can reduce critical limb ischemia events in addition to reducing coronary events, stroke, and overall mortality.

The very low dosage of rivaroxaban used in COMPASS, 2.5 mg twice daily, seems to be a very important part of the study’s design. This dosage appeared to hit the sweet spot of being large enough to reduce events but with a gentle enough anticoagulation effect to avoid a significant increase in fatal, intracerebral, or critical organ bleeds. However, the patients enrolled in COMPASS, like most patients who enter trials, were generally at a lower risk for bleeding complications than we usually see in routine practice in patients with stable coronary or peripheral artery disease. Presuming that the Food and Drug Administration will soon approve the 2.5-mg formulation of rivaroxaban used in COMPASS, clinicians will need to be careful using this regimen on patients at increased risk for bleeding, such as frail or elderly patients with a history of bleeding events or taking other treatments that could increase bleeding risk, such as nonsteroidal anti-inflammatory drugs. In general, clinicians are wary of using treatments that increase bleeding risk, and so they may hesitate to use this combination of rivaroxaban plus aspirin in patients with a high bleeding risk.

The success of the approach used in COMPASS became possible with the introduction of the new oral anticoagulant drugs. Now that this class of agents has been available for a few years, clinicians have grown increasingly comfortable with them, compared with warfarin. When the new oral anticoagulants first came out, many considered them similar to warfarin. Today, there is a better appreciation that these drugs are distinct from warfarin by really causing fewer bleeding complications.

Dr. Christopher B. Granger

 

Christopher B. Granger, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research support from Bayer and from other drugs companies that market new oral anticoagulants. He made these comments in an interview.

Body

 

The key message from COMPASS was that, although adding a very low dosage of rivaroxaban to aspirin in patients with stable coronary or peripheral artery disease resulted in a clear increase in major bleeding events, patients received an overall net beneficial effect from the combined regimen. The finding that clinches the net benefit from the rivaroxaban plus aspirin combination, compared with aspirin alone, was that the combined regimen produced a statistically significant relative risk reduction of 18% for all-cause mortality. This finding reinforces the idea that the primary outcome was beneficial despite an increase in major bleeding events.

The finding that rivaroxaban plus aspirin produced benefit with a modest increase in bleeding risk in patients with peripheral artery disease (PAD) is especially important because PAD is really difficult to treat. Very few interventions have previously been proven to have a beneficial effect for patients with PAD. It’s very important to find an intervention that can reduce critical limb ischemia events in addition to reducing coronary events, stroke, and overall mortality.

The very low dosage of rivaroxaban used in COMPASS, 2.5 mg twice daily, seems to be a very important part of the study’s design. This dosage appeared to hit the sweet spot of being large enough to reduce events but with a gentle enough anticoagulation effect to avoid a significant increase in fatal, intracerebral, or critical organ bleeds. However, the patients enrolled in COMPASS, like most patients who enter trials, were generally at a lower risk for bleeding complications than we usually see in routine practice in patients with stable coronary or peripheral artery disease. Presuming that the Food and Drug Administration will soon approve the 2.5-mg formulation of rivaroxaban used in COMPASS, clinicians will need to be careful using this regimen on patients at increased risk for bleeding, such as frail or elderly patients with a history of bleeding events or taking other treatments that could increase bleeding risk, such as nonsteroidal anti-inflammatory drugs. In general, clinicians are wary of using treatments that increase bleeding risk, and so they may hesitate to use this combination of rivaroxaban plus aspirin in patients with a high bleeding risk.

The success of the approach used in COMPASS became possible with the introduction of the new oral anticoagulant drugs. Now that this class of agents has been available for a few years, clinicians have grown increasingly comfortable with them, compared with warfarin. When the new oral anticoagulants first came out, many considered them similar to warfarin. Today, there is a better appreciation that these drugs are distinct from warfarin by really causing fewer bleeding complications.

Dr. Christopher B. Granger

 

Christopher B. Granger, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research support from Bayer and from other drugs companies that market new oral anticoagulants. He made these comments in an interview.

Title
Low-dose rivaroxaban benefits despite increased bleeding
Low-dose rivaroxaban benefits despite increased bleeding

– Combined treatment with a very low dosage of the anticoagulant rivaroxaban plus low-dose aspirin produced significant cuts in major adverse coronary, cerebral, and peripheral artery disease events with just a modest rise in major bleeding events in patients with stable disease in the COMPASS pivotal, randomized trial with more than 27,000 patients.

The benefits from the rivaroxaban plus aspirin regimen included a statistically significant 24% relative risk reduction in the study’s primary, combined endpoint, and a significant 18% relative risk reduction in all-cause death compared with a standard regimen of aspirin only, John W. Eikelboom, MD, said at the annual congress of the European Society of Cardiology. In addition, analysis of the net clinical benefit from treatment that took into account both the major adverse cardiovascular events prevented and major bleeding events induced, showed that the rivaroxaban-plus-aspirin regimen cut these by a statistically significant 20%, compared with aspirin alone.

Other notable benefits documented by the findings included a statistically significant 42% relative risk reduction for stroke and a statistically significant 46% relative risk reduction in the incidence of major adverse limb events among the roughly one-quarter of enrolled patients who entered the study with evidence of peripheral artery disease.

These risk reductions are similar in magnitude to the secondary-prevention benefits produced by controlling hypertension or dyslipidemia, noted Dr. Eikelboom, a researcher at McMaster University in Hamilton, Ont. “In the future, rivaroxaban will take its place among the other foundational treatments for long-term, secondary prevention,” he predicted in a video interview.

The COMPASS trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease,” commented Eugene Braunwald, MD, designated discussant for Dr. Eikelboom’s report. The results are “an important step for thrombocardiology,” said Dr. Braunwald, professor of medicine at Harvard Medical School in Boston.

Concurrently with Dr. Eikelboom’s report the results appeared in an article published online (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMoa1709118). This publication also include an editorial by Dr. Braunwald (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMe1710241).

Mitchel L. Zoler/Frontline Medical News
Dr. Eugene Braunwald


The Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS) trial enrolled 27,395 patients with stable coronary, carotid, or peripheral artery disease, or a combination of two or more of these, at 602 centers in 33 countries. About 90% of enrolled patients had coronary artery disease and 27% had peripheral artery disease. The enrolled patients averaged 68 year old and were an average of 7 years removed from their index arterial event. Randomization assigned patients to receive 2.5 mg rivaroxaban (Xarelto) twice daily plus 100 mg aspirin daily, 5 mg rivaroxaban twice daily, or 100 mg aspirin once daily. The trial stopped early, after an average follow-up of 23 months, because of the overwhelming benefit seen for the rivaroxaban plus aspirin combination. The rivaroxaban-monotherapy arm failed to show any statistically significant benefits, compared with the aspirin-monotherapy control group.

The study’s primary endpoint – the combined rate of cardiovascular disease death, nonfatal stroke, and nonfatal MI – occurred in 4.1% of patients in the rivaroxaban-plus-aspirin group and in 5.4% of patients on aspirin alone. The rate of major bleeding events was 3.1% among patients on rivaroxaban plus aspirin and 1.9% in those who received aspirin only, a 51% relative increase among patients on the dual regimen, but the results showed no statistically significant increase in the rates of fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.

Sonia Anand, MD, a colleague of Dr. Eikelboom’s at McMaster, presented a separate set of analyses that focused on the 7,470 enrolled patients who had been diagnosed at enrollment with peripheral artery disease. In this subgroup, the rivaroxaban-plus-aspirin regimen produced a statistically significant 28% relative risk reduction in the rate of the primary endpoint, compared with the aspirin control group. The dual regimen also produced a statistically significant 46% relative risk reduction in major adverse limb events and a significant 70% relative reduction in the incidence of major lower-extremity amputations, reported Dr. Anand, professor of medicine and director of the vascular medicine clinic at McMaster.
Mitchel L. Zoler/Frontline Medical News
Dr. Sonia Anand


The COMPASS findings follow a 2012 published report from the ATLAS ACS 2-TIMI 51 trial showing that treatment with the same low-dose rivaroxaban regimen plus aspirin and a thienopyridine (clopidogrel or ticlopidine) reduced the same combined triple endpoint by a statistically significant 16%, compared with aspirin and a thienopyridine alone, in patients with a recent acute coronary syndrome event (N Engl J Med. 2012 Jan 5;366[1]:9-19). Despite this evidence, the Food and Drug Administration never approved the 2.5-mg formulation of rivaroxaban, nor did it approve marketing of rivaroxaban for this acute coronary syndrome population. This decision may have been driven in part by a problem with incomplete follow-up of several of the enrolled patients.

The COMPASS results were “very consistent” with the ATLAS ACS 2-TIMI 51 results. noted Dr. Eikelboom. “I think it’s time to look at these two trials in combination,” he suggested. Availability of the 2.5-mg rivaroxaban formulation used in both trials would allow “a treatment strategy that could start early after an acute coronary syndrome event and then extend long term,” he said.

COMPASS was sponsored by Bayer, which markets rivaroxaban (Xarelto). Dr. Eikelboom has received research support from Bayer and also from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Janssen, Pfizer, Portola, and Sanofi. Dr. Anand has received speaking honoraria from several drug compnies. Dr. Braunwald had no disclosures.

 

 

 

 

– Combined treatment with a very low dosage of the anticoagulant rivaroxaban plus low-dose aspirin produced significant cuts in major adverse coronary, cerebral, and peripheral artery disease events with just a modest rise in major bleeding events in patients with stable disease in the COMPASS pivotal, randomized trial with more than 27,000 patients.

The benefits from the rivaroxaban plus aspirin regimen included a statistically significant 24% relative risk reduction in the study’s primary, combined endpoint, and a significant 18% relative risk reduction in all-cause death compared with a standard regimen of aspirin only, John W. Eikelboom, MD, said at the annual congress of the European Society of Cardiology. In addition, analysis of the net clinical benefit from treatment that took into account both the major adverse cardiovascular events prevented and major bleeding events induced, showed that the rivaroxaban-plus-aspirin regimen cut these by a statistically significant 20%, compared with aspirin alone.

Other notable benefits documented by the findings included a statistically significant 42% relative risk reduction for stroke and a statistically significant 46% relative risk reduction in the incidence of major adverse limb events among the roughly one-quarter of enrolled patients who entered the study with evidence of peripheral artery disease.

These risk reductions are similar in magnitude to the secondary-prevention benefits produced by controlling hypertension or dyslipidemia, noted Dr. Eikelboom, a researcher at McMaster University in Hamilton, Ont. “In the future, rivaroxaban will take its place among the other foundational treatments for long-term, secondary prevention,” he predicted in a video interview.

The COMPASS trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease,” commented Eugene Braunwald, MD, designated discussant for Dr. Eikelboom’s report. The results are “an important step for thrombocardiology,” said Dr. Braunwald, professor of medicine at Harvard Medical School in Boston.

Concurrently with Dr. Eikelboom’s report the results appeared in an article published online (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMoa1709118). This publication also include an editorial by Dr. Braunwald (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMe1710241).

Mitchel L. Zoler/Frontline Medical News
Dr. Eugene Braunwald


The Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS) trial enrolled 27,395 patients with stable coronary, carotid, or peripheral artery disease, or a combination of two or more of these, at 602 centers in 33 countries. About 90% of enrolled patients had coronary artery disease and 27% had peripheral artery disease. The enrolled patients averaged 68 year old and were an average of 7 years removed from their index arterial event. Randomization assigned patients to receive 2.5 mg rivaroxaban (Xarelto) twice daily plus 100 mg aspirin daily, 5 mg rivaroxaban twice daily, or 100 mg aspirin once daily. The trial stopped early, after an average follow-up of 23 months, because of the overwhelming benefit seen for the rivaroxaban plus aspirin combination. The rivaroxaban-monotherapy arm failed to show any statistically significant benefits, compared with the aspirin-monotherapy control group.

The study’s primary endpoint – the combined rate of cardiovascular disease death, nonfatal stroke, and nonfatal MI – occurred in 4.1% of patients in the rivaroxaban-plus-aspirin group and in 5.4% of patients on aspirin alone. The rate of major bleeding events was 3.1% among patients on rivaroxaban plus aspirin and 1.9% in those who received aspirin only, a 51% relative increase among patients on the dual regimen, but the results showed no statistically significant increase in the rates of fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.

Sonia Anand, MD, a colleague of Dr. Eikelboom’s at McMaster, presented a separate set of analyses that focused on the 7,470 enrolled patients who had been diagnosed at enrollment with peripheral artery disease. In this subgroup, the rivaroxaban-plus-aspirin regimen produced a statistically significant 28% relative risk reduction in the rate of the primary endpoint, compared with the aspirin control group. The dual regimen also produced a statistically significant 46% relative risk reduction in major adverse limb events and a significant 70% relative reduction in the incidence of major lower-extremity amputations, reported Dr. Anand, professor of medicine and director of the vascular medicine clinic at McMaster.
Mitchel L. Zoler/Frontline Medical News
Dr. Sonia Anand


The COMPASS findings follow a 2012 published report from the ATLAS ACS 2-TIMI 51 trial showing that treatment with the same low-dose rivaroxaban regimen plus aspirin and a thienopyridine (clopidogrel or ticlopidine) reduced the same combined triple endpoint by a statistically significant 16%, compared with aspirin and a thienopyridine alone, in patients with a recent acute coronary syndrome event (N Engl J Med. 2012 Jan 5;366[1]:9-19). Despite this evidence, the Food and Drug Administration never approved the 2.5-mg formulation of rivaroxaban, nor did it approve marketing of rivaroxaban for this acute coronary syndrome population. This decision may have been driven in part by a problem with incomplete follow-up of several of the enrolled patients.

The COMPASS results were “very consistent” with the ATLAS ACS 2-TIMI 51 results. noted Dr. Eikelboom. “I think it’s time to look at these two trials in combination,” he suggested. Availability of the 2.5-mg rivaroxaban formulation used in both trials would allow “a treatment strategy that could start early after an acute coronary syndrome event and then extend long term,” he said.

COMPASS was sponsored by Bayer, which markets rivaroxaban (Xarelto). Dr. Eikelboom has received research support from Bayer and also from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Janssen, Pfizer, Portola, and Sanofi. Dr. Anand has received speaking honoraria from several drug compnies. Dr. Braunwald had no disclosures.

 

 

 

 

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Key clinical point: A very low dosage of the anticoagulant rivaroxaban plus aspirin outperformed aspirin alone for preventing cardiovascular events in patients with stable coronary, peripheral, or carotid artery disease.

Major finding: The dual regimen reduced the combined rate of cardiovascular disease events by 24%, compared with aspirin alone.

Data source: COMPASS is a multicenter, randomized controlled trial with 27,395 patients.

Disclosures: COMPASS was sponsored by Bayer, which markets rivaroxaban (Xarelto). Dr. Eikelboom has received research support from Bayer and also from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Janssen, Pfizer, Portola, and Sanofi. Dr. Anand has received speaking honoraria from several drug compnies. Dr. Braunwald had no disclosures.

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Sneak Peek: The Hospital Leader blog - Aug. 2017 “A Conversation with Dr. Eric Howell”

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The essentials of QI: It starts with leadership.

Quality improvement became a foundational theme for SHM early in the growth of hospitalists. It’s not a coincidence that many of our leaders, such as Bob Wachter, Win Whitcomb, Greg Maynard, and Mark Williams are QI leaders as well. As hospitalists, we were and are best positioned to impact quality in the hospital.

Eric Howell, MD, of Johns Hopkins Bayview Medical Center in Baltimore serves as the senior physician advisor for SHM’s Center for Quality Improvement, while Jenna Goldstein runs the day-to-day aspects at SHM headquarters. A few months ago, Dr. Howell and I discussed how he started in QI, the role of SHM’s Center, and how hospitalists can receive effective QI training. The following Q&A is edited for conciseness and clarity.

Dr. Jordan Messler

You’ve been a leader in QI for many years; how did you get started in QI?

I trained as an electrical engineer before I went to medical school, which helped me when I went to residency.

When I was a chief at Hopkins Bayview in 1999, there were a number of systems-related issues, including throughput from the emergency department. I became involved with QI because I looked at these systems, thinking they could be better if I used the lens of an engineer. The hospital was very interested in reducing costs, and the physicians, including myself, were interested in making things safer. I was successful because I didn’t just focus on QI but on both sides of the value equation. In the early 2000s, I started to do more and more re-engineering and system improvement projects, and I found them very rewarding. As I showed some success, I was asked to do more.

What you are describing is hands-on training, learning by doing. It seems a lot of your QI training was hands on, as opposed to structured coursework. Was there formal training or is getting your hands dirty in a project the best way to start learning QI?

There is no replacement for actually doing it.

My training was in leadership, which is an integral part of QI. It’s pretty hard to get people to change for quality if you can’t lead them through that change. Initially, I did a lot of work to improve my leadership potential. As faculty, we taught teaching skills, which is a part of leadership. I spent time teaching residents best practices. That’s why I became involved early on with SHM’s Leadership Academy from its start in 2005. I also read a lot of books and still read often to improve my weaknesses. I have my own physicians go through Lean Six Sigma training and get their green belt or black belt.

That said, there is no substitute for doing it and, as they say, “bruising your knuckles” in QI.

Read the full post at hospitalleader.org.

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The essentials of QI: It starts with leadership.
The essentials of QI: It starts with leadership.

Quality improvement became a foundational theme for SHM early in the growth of hospitalists. It’s not a coincidence that many of our leaders, such as Bob Wachter, Win Whitcomb, Greg Maynard, and Mark Williams are QI leaders as well. As hospitalists, we were and are best positioned to impact quality in the hospital.

Eric Howell, MD, of Johns Hopkins Bayview Medical Center in Baltimore serves as the senior physician advisor for SHM’s Center for Quality Improvement, while Jenna Goldstein runs the day-to-day aspects at SHM headquarters. A few months ago, Dr. Howell and I discussed how he started in QI, the role of SHM’s Center, and how hospitalists can receive effective QI training. The following Q&A is edited for conciseness and clarity.

Dr. Jordan Messler

You’ve been a leader in QI for many years; how did you get started in QI?

I trained as an electrical engineer before I went to medical school, which helped me when I went to residency.

When I was a chief at Hopkins Bayview in 1999, there were a number of systems-related issues, including throughput from the emergency department. I became involved with QI because I looked at these systems, thinking they could be better if I used the lens of an engineer. The hospital was very interested in reducing costs, and the physicians, including myself, were interested in making things safer. I was successful because I didn’t just focus on QI but on both sides of the value equation. In the early 2000s, I started to do more and more re-engineering and system improvement projects, and I found them very rewarding. As I showed some success, I was asked to do more.

What you are describing is hands-on training, learning by doing. It seems a lot of your QI training was hands on, as opposed to structured coursework. Was there formal training or is getting your hands dirty in a project the best way to start learning QI?

There is no replacement for actually doing it.

My training was in leadership, which is an integral part of QI. It’s pretty hard to get people to change for quality if you can’t lead them through that change. Initially, I did a lot of work to improve my leadership potential. As faculty, we taught teaching skills, which is a part of leadership. I spent time teaching residents best practices. That’s why I became involved early on with SHM’s Leadership Academy from its start in 2005. I also read a lot of books and still read often to improve my weaknesses. I have my own physicians go through Lean Six Sigma training and get their green belt or black belt.

That said, there is no substitute for doing it and, as they say, “bruising your knuckles” in QI.

Read the full post at hospitalleader.org.

Also on The Hospital Leader

Quality improvement became a foundational theme for SHM early in the growth of hospitalists. It’s not a coincidence that many of our leaders, such as Bob Wachter, Win Whitcomb, Greg Maynard, and Mark Williams are QI leaders as well. As hospitalists, we were and are best positioned to impact quality in the hospital.

Eric Howell, MD, of Johns Hopkins Bayview Medical Center in Baltimore serves as the senior physician advisor for SHM’s Center for Quality Improvement, while Jenna Goldstein runs the day-to-day aspects at SHM headquarters. A few months ago, Dr. Howell and I discussed how he started in QI, the role of SHM’s Center, and how hospitalists can receive effective QI training. The following Q&A is edited for conciseness and clarity.

Dr. Jordan Messler

You’ve been a leader in QI for many years; how did you get started in QI?

I trained as an electrical engineer before I went to medical school, which helped me when I went to residency.

When I was a chief at Hopkins Bayview in 1999, there were a number of systems-related issues, including throughput from the emergency department. I became involved with QI because I looked at these systems, thinking they could be better if I used the lens of an engineer. The hospital was very interested in reducing costs, and the physicians, including myself, were interested in making things safer. I was successful because I didn’t just focus on QI but on both sides of the value equation. In the early 2000s, I started to do more and more re-engineering and system improvement projects, and I found them very rewarding. As I showed some success, I was asked to do more.

What you are describing is hands-on training, learning by doing. It seems a lot of your QI training was hands on, as opposed to structured coursework. Was there formal training or is getting your hands dirty in a project the best way to start learning QI?

There is no replacement for actually doing it.

My training was in leadership, which is an integral part of QI. It’s pretty hard to get people to change for quality if you can’t lead them through that change. Initially, I did a lot of work to improve my leadership potential. As faculty, we taught teaching skills, which is a part of leadership. I spent time teaching residents best practices. That’s why I became involved early on with SHM’s Leadership Academy from its start in 2005. I also read a lot of books and still read often to improve my weaknesses. I have my own physicians go through Lean Six Sigma training and get their green belt or black belt.

That said, there is no substitute for doing it and, as they say, “bruising your knuckles” in QI.

Read the full post at hospitalleader.org.

Also on The Hospital Leader

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Forgo supplemental oxygen in adequately perfused patients with acute MI, study suggests

Practice should change
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Supplemental oxygen did not prevent mortality or rehospitalization among patients with suspected myocardial infarction whose oxygen saturation on room air exceeded 90%, investigators reported.

Rates of all-cause mortality at 1 year were 5% among patients who received supplemental oxygen through an open face mask (6 liters per minute for 6-12 hours) and 5.1% among patients who breathed room air, said Robin Hofmann, MD, of Karolinska Institutet, Stockholm, and his associates. In addition, rehospitalization for MI occurred in 3.8% of patients who received supplemental oxygen and 3.3% of those breathed room air. The findings of the randomized registry-based trial of 6,629 patients were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.

Guidelines recommend oxygen supplementation in MI, and the practice has persisted for more than a century, but adequately powered trials of hard clinical endpoints are lacking. Above-normal oxygen saturation can potentially worsen reperfusion injury by causing coronary vasoconstriction and increasing production of reactive oxygen species, the researchers noted.

Notably, the Australian Air Versus Oxygen in Myocardial Infarction (AVOID) trial found that oxygen supplementation was associated with larger infarct sizes in patients with ST-segment elevation myocardial infarction, and a recent Cochrane report did not support routine oxygen supplementation for MI.

The current trial enrolled patients aged 30 years and older who had chest pain or shortness of breath lasting less than 6 hours, an oxygen saturation of at least 90% on pulse oximetry, and either electrocardiographic evidence of ischemia or elevated cardiac troponin T or I levels (N Engl J Med. 2017 Aug 28. doi: 10.1056/NEJMoa1706222).

Oxygen therapy lasted a median of 11.6 hours, after which median oxygen saturation levels were 99% in the intervention group and 97% in the control group.

A total of 62 patients (2%) who received oxygen developed hypoxemia, as did 254 patients (8%) who breathed room air. Median highest troponin levels during hospitalization were 946.5 ng per L and 983.0 ng per L, respectively. A total of 166 (5%) patients in the oxygen group and 168 (5.1%) control patients died from any cause by a year after treatment (hazard ratio, 0.97; P = .8). Likewise, supplemental oxygen did not prevent rehospitalization with MI within 1 year (HR, 1.13; P = .3).

“Because power for evaluation of the primary endpoint was lower than anticipated, we cannot completely rule out a small beneficial or detrimental effect of oxygen on mortality,” the researchers wrote. But clinical differences were unlikely, based on the superimposable time-to-event curves through 12 months, the consistent results across subgroups, and the neutral findings on secondary clinical endpoints, they added.

The Swedish Research Council, the Swedish Heart-Lung Foundation, and the Swedish Foundation for Strategic Research funded the study. Dr. Hofmann disclosed research grants from these entities.

Body

The study by Hofmann and coworkers provides definitive evidence for a lack of benefit of supplemental oxygen therapy in patients with acute myocardial infarction who have normal oxygen saturation. Although the mechanisms underlying physiological and biochemical adaptation to myocardial ischemia are complex, the answer to the question is straightforward, and its implications for coronary care are indisputable: Supplemental oxygen provides no benefit to patients with acute coronary syndromes who do not have hypoxemia. It is clearly time for clinical practice to change to reflect this definitive evidence.

Joseph Loscalzo, MD, PhD, is in the department of medicine, Brigham and Women’s Hospital, Boston. He is an editor-at-large for the New England Journal of Medicine. He had no other disclosures. These comments are from his accompanying editorial (N Engl J Med. 2017 Aug 28. doi: 10.1056/NEJMe1709250).

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The study by Hofmann and coworkers provides definitive evidence for a lack of benefit of supplemental oxygen therapy in patients with acute myocardial infarction who have normal oxygen saturation. Although the mechanisms underlying physiological and biochemical adaptation to myocardial ischemia are complex, the answer to the question is straightforward, and its implications for coronary care are indisputable: Supplemental oxygen provides no benefit to patients with acute coronary syndromes who do not have hypoxemia. It is clearly time for clinical practice to change to reflect this definitive evidence.

Joseph Loscalzo, MD, PhD, is in the department of medicine, Brigham and Women’s Hospital, Boston. He is an editor-at-large for the New England Journal of Medicine. He had no other disclosures. These comments are from his accompanying editorial (N Engl J Med. 2017 Aug 28. doi: 10.1056/NEJMe1709250).

Body

The study by Hofmann and coworkers provides definitive evidence for a lack of benefit of supplemental oxygen therapy in patients with acute myocardial infarction who have normal oxygen saturation. Although the mechanisms underlying physiological and biochemical adaptation to myocardial ischemia are complex, the answer to the question is straightforward, and its implications for coronary care are indisputable: Supplemental oxygen provides no benefit to patients with acute coronary syndromes who do not have hypoxemia. It is clearly time for clinical practice to change to reflect this definitive evidence.

Joseph Loscalzo, MD, PhD, is in the department of medicine, Brigham and Women’s Hospital, Boston. He is an editor-at-large for the New England Journal of Medicine. He had no other disclosures. These comments are from his accompanying editorial (N Engl J Med. 2017 Aug 28. doi: 10.1056/NEJMe1709250).

Title
Practice should change
Practice should change

Supplemental oxygen did not prevent mortality or rehospitalization among patients with suspected myocardial infarction whose oxygen saturation on room air exceeded 90%, investigators reported.

Rates of all-cause mortality at 1 year were 5% among patients who received supplemental oxygen through an open face mask (6 liters per minute for 6-12 hours) and 5.1% among patients who breathed room air, said Robin Hofmann, MD, of Karolinska Institutet, Stockholm, and his associates. In addition, rehospitalization for MI occurred in 3.8% of patients who received supplemental oxygen and 3.3% of those breathed room air. The findings of the randomized registry-based trial of 6,629 patients were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.

Guidelines recommend oxygen supplementation in MI, and the practice has persisted for more than a century, but adequately powered trials of hard clinical endpoints are lacking. Above-normal oxygen saturation can potentially worsen reperfusion injury by causing coronary vasoconstriction and increasing production of reactive oxygen species, the researchers noted.

Notably, the Australian Air Versus Oxygen in Myocardial Infarction (AVOID) trial found that oxygen supplementation was associated with larger infarct sizes in patients with ST-segment elevation myocardial infarction, and a recent Cochrane report did not support routine oxygen supplementation for MI.

The current trial enrolled patients aged 30 years and older who had chest pain or shortness of breath lasting less than 6 hours, an oxygen saturation of at least 90% on pulse oximetry, and either electrocardiographic evidence of ischemia or elevated cardiac troponin T or I levels (N Engl J Med. 2017 Aug 28. doi: 10.1056/NEJMoa1706222).

Oxygen therapy lasted a median of 11.6 hours, after which median oxygen saturation levels were 99% in the intervention group and 97% in the control group.

A total of 62 patients (2%) who received oxygen developed hypoxemia, as did 254 patients (8%) who breathed room air. Median highest troponin levels during hospitalization were 946.5 ng per L and 983.0 ng per L, respectively. A total of 166 (5%) patients in the oxygen group and 168 (5.1%) control patients died from any cause by a year after treatment (hazard ratio, 0.97; P = .8). Likewise, supplemental oxygen did not prevent rehospitalization with MI within 1 year (HR, 1.13; P = .3).

“Because power for evaluation of the primary endpoint was lower than anticipated, we cannot completely rule out a small beneficial or detrimental effect of oxygen on mortality,” the researchers wrote. But clinical differences were unlikely, based on the superimposable time-to-event curves through 12 months, the consistent results across subgroups, and the neutral findings on secondary clinical endpoints, they added.

The Swedish Research Council, the Swedish Heart-Lung Foundation, and the Swedish Foundation for Strategic Research funded the study. Dr. Hofmann disclosed research grants from these entities.

Supplemental oxygen did not prevent mortality or rehospitalization among patients with suspected myocardial infarction whose oxygen saturation on room air exceeded 90%, investigators reported.

Rates of all-cause mortality at 1 year were 5% among patients who received supplemental oxygen through an open face mask (6 liters per minute for 6-12 hours) and 5.1% among patients who breathed room air, said Robin Hofmann, MD, of Karolinska Institutet, Stockholm, and his associates. In addition, rehospitalization for MI occurred in 3.8% of patients who received supplemental oxygen and 3.3% of those breathed room air. The findings of the randomized registry-based trial of 6,629 patients were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.

Guidelines recommend oxygen supplementation in MI, and the practice has persisted for more than a century, but adequately powered trials of hard clinical endpoints are lacking. Above-normal oxygen saturation can potentially worsen reperfusion injury by causing coronary vasoconstriction and increasing production of reactive oxygen species, the researchers noted.

Notably, the Australian Air Versus Oxygen in Myocardial Infarction (AVOID) trial found that oxygen supplementation was associated with larger infarct sizes in patients with ST-segment elevation myocardial infarction, and a recent Cochrane report did not support routine oxygen supplementation for MI.

The current trial enrolled patients aged 30 years and older who had chest pain or shortness of breath lasting less than 6 hours, an oxygen saturation of at least 90% on pulse oximetry, and either electrocardiographic evidence of ischemia or elevated cardiac troponin T or I levels (N Engl J Med. 2017 Aug 28. doi: 10.1056/NEJMoa1706222).

Oxygen therapy lasted a median of 11.6 hours, after which median oxygen saturation levels were 99% in the intervention group and 97% in the control group.

A total of 62 patients (2%) who received oxygen developed hypoxemia, as did 254 patients (8%) who breathed room air. Median highest troponin levels during hospitalization were 946.5 ng per L and 983.0 ng per L, respectively. A total of 166 (5%) patients in the oxygen group and 168 (5.1%) control patients died from any cause by a year after treatment (hazard ratio, 0.97; P = .8). Likewise, supplemental oxygen did not prevent rehospitalization with MI within 1 year (HR, 1.13; P = .3).

“Because power for evaluation of the primary endpoint was lower than anticipated, we cannot completely rule out a small beneficial or detrimental effect of oxygen on mortality,” the researchers wrote. But clinical differences were unlikely, based on the superimposable time-to-event curves through 12 months, the consistent results across subgroups, and the neutral findings on secondary clinical endpoints, they added.

The Swedish Research Council, the Swedish Heart-Lung Foundation, and the Swedish Foundation for Strategic Research funded the study. Dr. Hofmann disclosed research grants from these entities.

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FROM THE ESC CONGRESS 2017

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Key clinical point: Supplemental oxygen did not benefit patients with suspected myocardial infarction who did not have hypoxemia.

Major finding: At 1 year, rates of all-cause mortality were 5% among patients who received supplemental oxygen and 5.1% among those who received no oxygen.

Data source: A registry-based, randomized clinical trial of 6,629 patients with suspected myocardial infarction without hypoxemia.

Disclosures: The Swedish Research Council, the Swedish Heart-Lung Foundation, and the Swedish Foundation for Strategic Research funded the study. Dr. Hofmann disclosed research grants from these entities.

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Rapid AMI rule out

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Clinical Question: Can a single high-sensitivity cardiac troponin-T (hs-cTnT) reliably rule-out acute myocardial infarction (AMI) to safely enable earlier discharge?

Background: Current practice includes serial measures of hs-cTnT to rule out AMI.

Study Design: A meta-analysis of 11 prospective cohorts at various international locations

Setting: Patients presenting to emergency departments with chest pain.

Dr. Prerna Dogra


Synopsis: Of 9,241, a total of 2,825 patients were classified as low risk with a single negative hs-cTnT and nonischemic EKG. The primary outcome was AMI during initial hospitalization. Of low-risk patients, 14 (0.5%) had AMI. Pooled estimated sensitivity was 98.7% and pooled negative predictive value was 99.3%. For the secondary outcome of 30-day major adverse cardiac events, pooled sensitivity was 98%. Limitations include a small number of studies, high statistical heterogeneity, variation in troponin assays, and variable prevalence of AMI across studies.

Bottom Line: A single negative hs-cTnT and nonischemic EKG after three hours of chest pain can reliably rule out AMI. Further research is, however, required to validate the unequivocal use of this early rule out strategy.

Citation: Pickering J, Than M, Cullen L, et al. Rapid rule-out of acute myocardial infarction with a single high-sensitivity cardiac troponin t measurement below the limit of detection: A collaborative meta-analysis. Ann Intern Med. 2017 May 16;166(10):715-24.

Dr. Dogra is clinical instructor of medicine in the University of Kentucky division of hospital medicine.

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Clinical Question: Can a single high-sensitivity cardiac troponin-T (hs-cTnT) reliably rule-out acute myocardial infarction (AMI) to safely enable earlier discharge?

Background: Current practice includes serial measures of hs-cTnT to rule out AMI.

Study Design: A meta-analysis of 11 prospective cohorts at various international locations

Setting: Patients presenting to emergency departments with chest pain.

Dr. Prerna Dogra


Synopsis: Of 9,241, a total of 2,825 patients were classified as low risk with a single negative hs-cTnT and nonischemic EKG. The primary outcome was AMI during initial hospitalization. Of low-risk patients, 14 (0.5%) had AMI. Pooled estimated sensitivity was 98.7% and pooled negative predictive value was 99.3%. For the secondary outcome of 30-day major adverse cardiac events, pooled sensitivity was 98%. Limitations include a small number of studies, high statistical heterogeneity, variation in troponin assays, and variable prevalence of AMI across studies.

Bottom Line: A single negative hs-cTnT and nonischemic EKG after three hours of chest pain can reliably rule out AMI. Further research is, however, required to validate the unequivocal use of this early rule out strategy.

Citation: Pickering J, Than M, Cullen L, et al. Rapid rule-out of acute myocardial infarction with a single high-sensitivity cardiac troponin t measurement below the limit of detection: A collaborative meta-analysis. Ann Intern Med. 2017 May 16;166(10):715-24.

Dr. Dogra is clinical instructor of medicine in the University of Kentucky division of hospital medicine.

 

Clinical Question: Can a single high-sensitivity cardiac troponin-T (hs-cTnT) reliably rule-out acute myocardial infarction (AMI) to safely enable earlier discharge?

Background: Current practice includes serial measures of hs-cTnT to rule out AMI.

Study Design: A meta-analysis of 11 prospective cohorts at various international locations

Setting: Patients presenting to emergency departments with chest pain.

Dr. Prerna Dogra


Synopsis: Of 9,241, a total of 2,825 patients were classified as low risk with a single negative hs-cTnT and nonischemic EKG. The primary outcome was AMI during initial hospitalization. Of low-risk patients, 14 (0.5%) had AMI. Pooled estimated sensitivity was 98.7% and pooled negative predictive value was 99.3%. For the secondary outcome of 30-day major adverse cardiac events, pooled sensitivity was 98%. Limitations include a small number of studies, high statistical heterogeneity, variation in troponin assays, and variable prevalence of AMI across studies.

Bottom Line: A single negative hs-cTnT and nonischemic EKG after three hours of chest pain can reliably rule out AMI. Further research is, however, required to validate the unequivocal use of this early rule out strategy.

Citation: Pickering J, Than M, Cullen L, et al. Rapid rule-out of acute myocardial infarction with a single high-sensitivity cardiac troponin t measurement below the limit of detection: A collaborative meta-analysis. Ann Intern Med. 2017 May 16;166(10):715-24.

Dr. Dogra is clinical instructor of medicine in the University of Kentucky division of hospital medicine.

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Undiagnosed AF common in higher-risk patients

Findings highly relevant
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Fri, 01/18/2019 - 16:59

Over an 18-month period, small, insertable cardiac monitors detected atrial fibrillation in 29% of previously undiagnosed patients who were at high risk of both AF and stroke, and in 40% of patients over 30 months, according to investigators. The study was presented at the annual congress of the European Society of Cardiology and simultaneously published in JAMA Cardiology.

More than half (56%) of patients consequently started oral anticoagulation therapy, noted James A. Reiffel, MD, of Columbia University College of Physicians and Surgeons, New York, with his associates, for the REVEAL AF investigators.

“The incidence of previously undiagnosed atrial fibrillation may be substantial in patients with risk factors for AF and stroke,” they concluded. “Atrial fibrillation would have gone undetected in most patients had monitoring been limited to 30 days. Further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted.”

Atrial fibrillation affects millions worldwide and is associated with older age, hypertension, diabetes, and heart failure, all of which also independently increase the risk of stroke. Minimally invasive prolonged electrocardiographic monitoring with insertable cardiac monitors might help hasten detection and treatment of AF, but diagnostic yield in high-risk patients has been unclear.

In this single-arm, multicenter, prospective study, researchers inserted Reveal XT or Reveal LINQ (Medtronic) cardiac monitors in 385 adults who had either CHAD2 scores of 3, or CHAD2 scores of 2 and one additional risk factor for AF, such as coronary artery disease, sleep apnea, chronic obstructive pulmonary disease, or renal insufficiency. The primary endpoint was AF lasting at least 6 minutes (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3180). Median follow-up time was 22.5 months. Rates of detecting AF were 6% at 30 days compared with 20% at 6 months, 27% at 12 months, 34% at 24 months, and 40% at 30 months. Patients typically had their first AF episode about 4 months (median, 123 days) after the device was inserted. Among patients who had experienced AF by 18 months, 10% had one or more episodes lasting at least 24 hours, and 72 (56%) were prescribed oral anticoagulation therapy.

The recent PREDATE AF and ASSERT-II studies also found that previously undiagnosed AF was common among high-risk patients, the researchers noted. However, whether anticoagulating patients who have only brief episodes of AF significantly reduces their risk of stroke remains unclear, they added. Three trials (ARTESiA, NOAH, and LOOP) are underway to assess whether oral anticoagulation therapy improves outcomes in patients with device-detected AF.

Medtronic funded the study. Dr. Reiffel and five coinvestigators disclosed consulting for and receiving “modest honoraria” from Medtronic. Two other coinvestigators reported employment with and stock ownership in Medtronic.

Body

The availability of safe and effective oral anticoagulant therapy makes the findings of REVEAL AF highly relevant. This high rate of incident AF makes ICM-based screenings of high-risk individuals a potentially attractive stroke prevention strategy. More detailed subgroup analyses may help identify a patient population with an even higher risk of developing AF. It is also conceivable that this population could have a sufficiently high risk of AF and stroke that a strategy of empiric oral anticoagulation, without the need for AF monitoring, could prove beneficial.

Dr. Jeff S. Healey
However; both intervention studies and economic evaluations are needed before either strategy should be routinely adopted.

The REVEAL AF study has shown that AF is extremely common among older individuals with stroke risk factors. Over the next 3-4 years, subgroup analyses, economic evaluations, and randomized clinical trials will help determine if this insight can be translated into a cost-effective stroke prevention strategy for high-risk individuals.

Jeff S. Healey, MD, MSc, is at the Population Health Research Institute, McMaster University, Hamilton, Ont. He is the principal investigator of the ASSERT-II and ARTESiA trials, and had no other relevant disclosures. These comments are from his editorial (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3203).

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The availability of safe and effective oral anticoagulant therapy makes the findings of REVEAL AF highly relevant. This high rate of incident AF makes ICM-based screenings of high-risk individuals a potentially attractive stroke prevention strategy. More detailed subgroup analyses may help identify a patient population with an even higher risk of developing AF. It is also conceivable that this population could have a sufficiently high risk of AF and stroke that a strategy of empiric oral anticoagulation, without the need for AF monitoring, could prove beneficial.

Dr. Jeff S. Healey
However; both intervention studies and economic evaluations are needed before either strategy should be routinely adopted.

The REVEAL AF study has shown that AF is extremely common among older individuals with stroke risk factors. Over the next 3-4 years, subgroup analyses, economic evaluations, and randomized clinical trials will help determine if this insight can be translated into a cost-effective stroke prevention strategy for high-risk individuals.

Jeff S. Healey, MD, MSc, is at the Population Health Research Institute, McMaster University, Hamilton, Ont. He is the principal investigator of the ASSERT-II and ARTESiA trials, and had no other relevant disclosures. These comments are from his editorial (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3203).

Body

The availability of safe and effective oral anticoagulant therapy makes the findings of REVEAL AF highly relevant. This high rate of incident AF makes ICM-based screenings of high-risk individuals a potentially attractive stroke prevention strategy. More detailed subgroup analyses may help identify a patient population with an even higher risk of developing AF. It is also conceivable that this population could have a sufficiently high risk of AF and stroke that a strategy of empiric oral anticoagulation, without the need for AF monitoring, could prove beneficial.

Dr. Jeff S. Healey
However; both intervention studies and economic evaluations are needed before either strategy should be routinely adopted.

The REVEAL AF study has shown that AF is extremely common among older individuals with stroke risk factors. Over the next 3-4 years, subgroup analyses, economic evaluations, and randomized clinical trials will help determine if this insight can be translated into a cost-effective stroke prevention strategy for high-risk individuals.

Jeff S. Healey, MD, MSc, is at the Population Health Research Institute, McMaster University, Hamilton, Ont. He is the principal investigator of the ASSERT-II and ARTESiA trials, and had no other relevant disclosures. These comments are from his editorial (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3203).

Title
Findings highly relevant
Findings highly relevant

Over an 18-month period, small, insertable cardiac monitors detected atrial fibrillation in 29% of previously undiagnosed patients who were at high risk of both AF and stroke, and in 40% of patients over 30 months, according to investigators. The study was presented at the annual congress of the European Society of Cardiology and simultaneously published in JAMA Cardiology.

More than half (56%) of patients consequently started oral anticoagulation therapy, noted James A. Reiffel, MD, of Columbia University College of Physicians and Surgeons, New York, with his associates, for the REVEAL AF investigators.

“The incidence of previously undiagnosed atrial fibrillation may be substantial in patients with risk factors for AF and stroke,” they concluded. “Atrial fibrillation would have gone undetected in most patients had monitoring been limited to 30 days. Further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted.”

Atrial fibrillation affects millions worldwide and is associated with older age, hypertension, diabetes, and heart failure, all of which also independently increase the risk of stroke. Minimally invasive prolonged electrocardiographic monitoring with insertable cardiac monitors might help hasten detection and treatment of AF, but diagnostic yield in high-risk patients has been unclear.

In this single-arm, multicenter, prospective study, researchers inserted Reveal XT or Reveal LINQ (Medtronic) cardiac monitors in 385 adults who had either CHAD2 scores of 3, or CHAD2 scores of 2 and one additional risk factor for AF, such as coronary artery disease, sleep apnea, chronic obstructive pulmonary disease, or renal insufficiency. The primary endpoint was AF lasting at least 6 minutes (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3180). Median follow-up time was 22.5 months. Rates of detecting AF were 6% at 30 days compared with 20% at 6 months, 27% at 12 months, 34% at 24 months, and 40% at 30 months. Patients typically had their first AF episode about 4 months (median, 123 days) after the device was inserted. Among patients who had experienced AF by 18 months, 10% had one or more episodes lasting at least 24 hours, and 72 (56%) were prescribed oral anticoagulation therapy.

The recent PREDATE AF and ASSERT-II studies also found that previously undiagnosed AF was common among high-risk patients, the researchers noted. However, whether anticoagulating patients who have only brief episodes of AF significantly reduces their risk of stroke remains unclear, they added. Three trials (ARTESiA, NOAH, and LOOP) are underway to assess whether oral anticoagulation therapy improves outcomes in patients with device-detected AF.

Medtronic funded the study. Dr. Reiffel and five coinvestigators disclosed consulting for and receiving “modest honoraria” from Medtronic. Two other coinvestigators reported employment with and stock ownership in Medtronic.

Over an 18-month period, small, insertable cardiac monitors detected atrial fibrillation in 29% of previously undiagnosed patients who were at high risk of both AF and stroke, and in 40% of patients over 30 months, according to investigators. The study was presented at the annual congress of the European Society of Cardiology and simultaneously published in JAMA Cardiology.

More than half (56%) of patients consequently started oral anticoagulation therapy, noted James A. Reiffel, MD, of Columbia University College of Physicians and Surgeons, New York, with his associates, for the REVEAL AF investigators.

“The incidence of previously undiagnosed atrial fibrillation may be substantial in patients with risk factors for AF and stroke,” they concluded. “Atrial fibrillation would have gone undetected in most patients had monitoring been limited to 30 days. Further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted.”

Atrial fibrillation affects millions worldwide and is associated with older age, hypertension, diabetes, and heart failure, all of which also independently increase the risk of stroke. Minimally invasive prolonged electrocardiographic monitoring with insertable cardiac monitors might help hasten detection and treatment of AF, but diagnostic yield in high-risk patients has been unclear.

In this single-arm, multicenter, prospective study, researchers inserted Reveal XT or Reveal LINQ (Medtronic) cardiac monitors in 385 adults who had either CHAD2 scores of 3, or CHAD2 scores of 2 and one additional risk factor for AF, such as coronary artery disease, sleep apnea, chronic obstructive pulmonary disease, or renal insufficiency. The primary endpoint was AF lasting at least 6 minutes (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3180). Median follow-up time was 22.5 months. Rates of detecting AF were 6% at 30 days compared with 20% at 6 months, 27% at 12 months, 34% at 24 months, and 40% at 30 months. Patients typically had their first AF episode about 4 months (median, 123 days) after the device was inserted. Among patients who had experienced AF by 18 months, 10% had one or more episodes lasting at least 24 hours, and 72 (56%) were prescribed oral anticoagulation therapy.

The recent PREDATE AF and ASSERT-II studies also found that previously undiagnosed AF was common among high-risk patients, the researchers noted. However, whether anticoagulating patients who have only brief episodes of AF significantly reduces their risk of stroke remains unclear, they added. Three trials (ARTESiA, NOAH, and LOOP) are underway to assess whether oral anticoagulation therapy improves outcomes in patients with device-detected AF.

Medtronic funded the study. Dr. Reiffel and five coinvestigators disclosed consulting for and receiving “modest honoraria” from Medtronic. Two other coinvestigators reported employment with and stock ownership in Medtronic.

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Key clinical point: Undiagnosed atrial fibrillation is common in high-risk patients.

Major finding: At 18 months, 29% of previously undiagnosed, high-risk patients had experienced atrial fibrillation lasting 6 or more minutes.

Data source: A single-arm, prospective, multicenter study of 446 patients with a CHADS2 score of at least 3, or a CHADS2 score of at least 2 plus at least one other risk factor (coronary artery disease, sleep apnea, chronic obstructive pulmonary disease, or renal insufficiency).

Disclosures: Medtronic funded the study. Dr. Reiffel and five coinvestigators disclosed consulting for and receiving “modest honoraria” from Medtronic. Two other coinvestigators reported employment with and stock ownership in Medtronic.

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Student Hospitalist Scholars: Strengthening research skills

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Diverse input makes a student research project more broadly accessible

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

I’m always surprised by how much I can learn in a few short weeks. I am now up to full speed with my project studying the utility of bone biopsies in the management of osteomyelitis.

This is a retrospective study, which means I’ll be collecting historical data from patient charts to be used for our analysis. My mentor – Ernie Esquivel, MD – has played an invaluable role in helping me get this project off the ground. He has worked with me on everything from project planning to successfully navigating the ever-confusing institutional review board (IRB) process. He has also provided advice in areas I thought I might actually have more experience, such as data collection and analysis methods.

Cole Hirschfeld
I worked in the finance industry prior to medical school and I became an expert at analyzing large data sets using Excel spreadsheets. However, I learned that Excel is not always the best tool to use for data collection, nor for handling sensitive patient information. Dr. Esquivel introduced me to a secure data collection program licensed by our institution called RedCAP. I was able to create a unique data input form that is specific to our project’s needs.

This form has streamlined the data collection process and will save me a significant amount of time down the road when we have to code the data for statistical analysis programs. After putting in the hard work gathering all of this information, I look forward to beginning the process of analyzing and interpreting our results.

Dr. Esquivel has also helped me improve the value and credibility of this research by encouraging me to present our ideas in front of several groups of people from different departments and specialties. The feedback from these meetings has helped refine our study design and methods while also providing me with the opportunity to improve my communication and presentation skills.

I think such diverse input has helped shape this project into something that will be accessible to a broader audience, and has strengthened my understanding of why our work is important to both clinicians and patients.

Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.

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Diverse input makes a student research project more broadly accessible
Diverse input makes a student research project more broadly accessible

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

I’m always surprised by how much I can learn in a few short weeks. I am now up to full speed with my project studying the utility of bone biopsies in the management of osteomyelitis.

This is a retrospective study, which means I’ll be collecting historical data from patient charts to be used for our analysis. My mentor – Ernie Esquivel, MD – has played an invaluable role in helping me get this project off the ground. He has worked with me on everything from project planning to successfully navigating the ever-confusing institutional review board (IRB) process. He has also provided advice in areas I thought I might actually have more experience, such as data collection and analysis methods.

Cole Hirschfeld
I worked in the finance industry prior to medical school and I became an expert at analyzing large data sets using Excel spreadsheets. However, I learned that Excel is not always the best tool to use for data collection, nor for handling sensitive patient information. Dr. Esquivel introduced me to a secure data collection program licensed by our institution called RedCAP. I was able to create a unique data input form that is specific to our project’s needs.

This form has streamlined the data collection process and will save me a significant amount of time down the road when we have to code the data for statistical analysis programs. After putting in the hard work gathering all of this information, I look forward to beginning the process of analyzing and interpreting our results.

Dr. Esquivel has also helped me improve the value and credibility of this research by encouraging me to present our ideas in front of several groups of people from different departments and specialties. The feedback from these meetings has helped refine our study design and methods while also providing me with the opportunity to improve my communication and presentation skills.

I think such diverse input has helped shape this project into something that will be accessible to a broader audience, and has strengthened my understanding of why our work is important to both clinicians and patients.

Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

I’m always surprised by how much I can learn in a few short weeks. I am now up to full speed with my project studying the utility of bone biopsies in the management of osteomyelitis.

This is a retrospective study, which means I’ll be collecting historical data from patient charts to be used for our analysis. My mentor – Ernie Esquivel, MD – has played an invaluable role in helping me get this project off the ground. He has worked with me on everything from project planning to successfully navigating the ever-confusing institutional review board (IRB) process. He has also provided advice in areas I thought I might actually have more experience, such as data collection and analysis methods.

Cole Hirschfeld
I worked in the finance industry prior to medical school and I became an expert at analyzing large data sets using Excel spreadsheets. However, I learned that Excel is not always the best tool to use for data collection, nor for handling sensitive patient information. Dr. Esquivel introduced me to a secure data collection program licensed by our institution called RedCAP. I was able to create a unique data input form that is specific to our project’s needs.

This form has streamlined the data collection process and will save me a significant amount of time down the road when we have to code the data for statistical analysis programs. After putting in the hard work gathering all of this information, I look forward to beginning the process of analyzing and interpreting our results.

Dr. Esquivel has also helped me improve the value and credibility of this research by encouraging me to present our ideas in front of several groups of people from different departments and specialties. The feedback from these meetings has helped refine our study design and methods while also providing me with the opportunity to improve my communication and presentation skills.

I think such diverse input has helped shape this project into something that will be accessible to a broader audience, and has strengthened my understanding of why our work is important to both clinicians and patients.

Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.

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Even short-term steroids can be problematic

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Clinical Question: What is the frequency of short-term corticosteroid prescriptions and adverse events associated with their use?

Background: Long-term corticosteroid use is usually avoided given risks of complications. Less is known about the risk and frequency of short-term corticosteroid use.

Study Design: Retrospective cohort study and self-controlled case series.

Setting: National U.S. dataset of private insurance claims.

Dr. Adam Gray


Synopsis: Data from 1,548,945 adults (aged 18-64 years) showed that 21.1% of adults received a prescription for short-term corticosteroids. Within 30 days of filling corticosteroids, incident rate ratios (IRR) were increased for sepsis (5.3; 95% confidence interval, 3.8-7.4), venous thromboembolism (3.3; 95% CI, 2.78-3.99), and fracture (1.87; 95% CI, 1.69-2.07).

Short-term corticosteroids were frequently prescribed for indications with little evidence of benefit, such as upper respiratory conditions, spinal conditions, and allergies. For these conditions, patients should be educated about the risks of short-term corticosteroid use and alternative treatments should be considered. This study only evaluated for these three adverse reactions and excluded the elderly, so these findings likely underestimate the adverse effects of short-term corticosteroids.

Bottom Line: Corticosteroids are frequently prescribed for short courses and were associated with increased rates of sepsis, venous thromboembolism, and fracture.

Citation: Waljee AK, Rogers MA, Lin P, et al. Short term use of oral corticosteroids and related harms among adults in the United States: Population based cohort study. BMJ. 2017;357:j1415.

Dr. Gray is assistant professor in the University of Kentucky division of hospital medicine and the Lexington VA Medical Center.

 

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Clinical Question: What is the frequency of short-term corticosteroid prescriptions and adverse events associated with their use?

Background: Long-term corticosteroid use is usually avoided given risks of complications. Less is known about the risk and frequency of short-term corticosteroid use.

Study Design: Retrospective cohort study and self-controlled case series.

Setting: National U.S. dataset of private insurance claims.

Dr. Adam Gray


Synopsis: Data from 1,548,945 adults (aged 18-64 years) showed that 21.1% of adults received a prescription for short-term corticosteroids. Within 30 days of filling corticosteroids, incident rate ratios (IRR) were increased for sepsis (5.3; 95% confidence interval, 3.8-7.4), venous thromboembolism (3.3; 95% CI, 2.78-3.99), and fracture (1.87; 95% CI, 1.69-2.07).

Short-term corticosteroids were frequently prescribed for indications with little evidence of benefit, such as upper respiratory conditions, spinal conditions, and allergies. For these conditions, patients should be educated about the risks of short-term corticosteroid use and alternative treatments should be considered. This study only evaluated for these three adverse reactions and excluded the elderly, so these findings likely underestimate the adverse effects of short-term corticosteroids.

Bottom Line: Corticosteroids are frequently prescribed for short courses and were associated with increased rates of sepsis, venous thromboembolism, and fracture.

Citation: Waljee AK, Rogers MA, Lin P, et al. Short term use of oral corticosteroids and related harms among adults in the United States: Population based cohort study. BMJ. 2017;357:j1415.

Dr. Gray is assistant professor in the University of Kentucky division of hospital medicine and the Lexington VA Medical Center.

 

 

Clinical Question: What is the frequency of short-term corticosteroid prescriptions and adverse events associated with their use?

Background: Long-term corticosteroid use is usually avoided given risks of complications. Less is known about the risk and frequency of short-term corticosteroid use.

Study Design: Retrospective cohort study and self-controlled case series.

Setting: National U.S. dataset of private insurance claims.

Dr. Adam Gray


Synopsis: Data from 1,548,945 adults (aged 18-64 years) showed that 21.1% of adults received a prescription for short-term corticosteroids. Within 30 days of filling corticosteroids, incident rate ratios (IRR) were increased for sepsis (5.3; 95% confidence interval, 3.8-7.4), venous thromboembolism (3.3; 95% CI, 2.78-3.99), and fracture (1.87; 95% CI, 1.69-2.07).

Short-term corticosteroids were frequently prescribed for indications with little evidence of benefit, such as upper respiratory conditions, spinal conditions, and allergies. For these conditions, patients should be educated about the risks of short-term corticosteroid use and alternative treatments should be considered. This study only evaluated for these three adverse reactions and excluded the elderly, so these findings likely underestimate the adverse effects of short-term corticosteroids.

Bottom Line: Corticosteroids are frequently prescribed for short courses and were associated with increased rates of sepsis, venous thromboembolism, and fracture.

Citation: Waljee AK, Rogers MA, Lin P, et al. Short term use of oral corticosteroids and related harms among adults in the United States: Population based cohort study. BMJ. 2017;357:j1415.

Dr. Gray is assistant professor in the University of Kentucky division of hospital medicine and the Lexington VA Medical Center.

 

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Axillary thermometry is the best choice for newborns

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– Axillary thermometry outperformed both rectal and temporal artery thermometry in 205 newborns aged 12-72 hours in a study performed at the University of North Carolina at Chapel Hill.

The infants had two temperatures taken by each method over a period of 15 minutes, for a total of six readings per child and 1,230 measurements overall. Axillary thermometry proved both accurate and reliable. Rectal thermometry was accurate but less reliable, and temporal thermometry was reliable but less accurate.

M. Alexander Otto/Frontline Medical News
Dr. Ketan Nadkarni
The American Academy of Pediatrics recommends rectal thermometers as the gold standard for children under 3 years old, but axillary thermometers are widely used, and temporal artery thermometers are becoming common. Nurses at the University of North Carolina generally have been using axillary thermometers in the nursery; they’re more convenient and less traumatic than rectal thermometers – especially for the provider – and there’s no risk of rectal injury. Parents, however, have been told to use rectal thermometers when they take their baby home.

Lead investigator Ketan Nadkarni, MD, a 3rd-year pediatrics resident, and his colleagues wanted to compare the three methods head-to-head to make sure axillary thermometers were okay to use in the nursery, and to see if it really was necessary to tell parents to use rectal thermometers; many are reluctant to use them. Plus, “there’s been a lot of controversy” in pediatrics “over the best way to measure temperature,” Dr. Nadkarni said at the Pediatric Hospital Medicine annual meeting.

“With our data, we think axillary is what we should continue to use in the newborn nursery,” he said. Some attending physicians still are hesitant to recommend axillary thermometers to new parents, but “all of the nurses are aware of” the study findings “and a lot of the residents are, too, so I think we are starting to move” in that direction.

The study had some unexpected findings as well: “The biggest surprise was how wide the distribution of rectal temperatures was. The distribution” around the mean “was way larger than we had thought, so [rectal thermometry was] not very reliable at all. Our study surprisingly exhibited suboptimal performance in terms of reliability,” for rectal thermometry, he said at the meeting, which was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Specifically, the average distance of any given rectal measurement from the mean rectal temperature of 98.3º F was 0.45º F. The second rectal temperature in the study sometimes varied a half a degree or more from the first taken shortly before, in the same infant.

The average distance of an axillary temperature from the axillary mean of 98.32º F was 0.32º F; for temporal thermometry it was 0.34º F from a mean of 98.55º F.

Another surprise was that temporal thermometry overestimated temperature by an average of about a quarter of a degree, compared with rectal readings. Even small overestimates could lead to unnecessary sepsis work-ups; “the last thing we want is to hospitalize these kids when they don’t need to be,” Dr. Nadkarni said.

The mean axillary and rectal temperatures, meanwhile, were only 0.02º F apart, which was not statistically significant. “Axillary was absolutely interchangeable with rectal in terms of accuracy,” he said.

The children were born at 37 weeks’ gestation or later, and were excluded if they had a temperature of 100.4º F or higher by any method. Rectal and axillary temperatures were taken with a Welch Allyn SureTemp Plus 690. Temple temperatures were taken with an Exergen TAT-2000c.

The investigators plan to run a similar trial in the ED with children up to 3 months old.

There was no external funding for the work, and Dr. Nadkarni had no relevant financial disclosures.

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– Axillary thermometry outperformed both rectal and temporal artery thermometry in 205 newborns aged 12-72 hours in a study performed at the University of North Carolina at Chapel Hill.

The infants had two temperatures taken by each method over a period of 15 minutes, for a total of six readings per child and 1,230 measurements overall. Axillary thermometry proved both accurate and reliable. Rectal thermometry was accurate but less reliable, and temporal thermometry was reliable but less accurate.

M. Alexander Otto/Frontline Medical News
Dr. Ketan Nadkarni
The American Academy of Pediatrics recommends rectal thermometers as the gold standard for children under 3 years old, but axillary thermometers are widely used, and temporal artery thermometers are becoming common. Nurses at the University of North Carolina generally have been using axillary thermometers in the nursery; they’re more convenient and less traumatic than rectal thermometers – especially for the provider – and there’s no risk of rectal injury. Parents, however, have been told to use rectal thermometers when they take their baby home.

Lead investigator Ketan Nadkarni, MD, a 3rd-year pediatrics resident, and his colleagues wanted to compare the three methods head-to-head to make sure axillary thermometers were okay to use in the nursery, and to see if it really was necessary to tell parents to use rectal thermometers; many are reluctant to use them. Plus, “there’s been a lot of controversy” in pediatrics “over the best way to measure temperature,” Dr. Nadkarni said at the Pediatric Hospital Medicine annual meeting.

“With our data, we think axillary is what we should continue to use in the newborn nursery,” he said. Some attending physicians still are hesitant to recommend axillary thermometers to new parents, but “all of the nurses are aware of” the study findings “and a lot of the residents are, too, so I think we are starting to move” in that direction.

The study had some unexpected findings as well: “The biggest surprise was how wide the distribution of rectal temperatures was. The distribution” around the mean “was way larger than we had thought, so [rectal thermometry was] not very reliable at all. Our study surprisingly exhibited suboptimal performance in terms of reliability,” for rectal thermometry, he said at the meeting, which was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Specifically, the average distance of any given rectal measurement from the mean rectal temperature of 98.3º F was 0.45º F. The second rectal temperature in the study sometimes varied a half a degree or more from the first taken shortly before, in the same infant.

The average distance of an axillary temperature from the axillary mean of 98.32º F was 0.32º F; for temporal thermometry it was 0.34º F from a mean of 98.55º F.

Another surprise was that temporal thermometry overestimated temperature by an average of about a quarter of a degree, compared with rectal readings. Even small overestimates could lead to unnecessary sepsis work-ups; “the last thing we want is to hospitalize these kids when they don’t need to be,” Dr. Nadkarni said.

The mean axillary and rectal temperatures, meanwhile, were only 0.02º F apart, which was not statistically significant. “Axillary was absolutely interchangeable with rectal in terms of accuracy,” he said.

The children were born at 37 weeks’ gestation or later, and were excluded if they had a temperature of 100.4º F or higher by any method. Rectal and axillary temperatures were taken with a Welch Allyn SureTemp Plus 690. Temple temperatures were taken with an Exergen TAT-2000c.

The investigators plan to run a similar trial in the ED with children up to 3 months old.

There was no external funding for the work, and Dr. Nadkarni had no relevant financial disclosures.

 

– Axillary thermometry outperformed both rectal and temporal artery thermometry in 205 newborns aged 12-72 hours in a study performed at the University of North Carolina at Chapel Hill.

The infants had two temperatures taken by each method over a period of 15 minutes, for a total of six readings per child and 1,230 measurements overall. Axillary thermometry proved both accurate and reliable. Rectal thermometry was accurate but less reliable, and temporal thermometry was reliable but less accurate.

M. Alexander Otto/Frontline Medical News
Dr. Ketan Nadkarni
The American Academy of Pediatrics recommends rectal thermometers as the gold standard for children under 3 years old, but axillary thermometers are widely used, and temporal artery thermometers are becoming common. Nurses at the University of North Carolina generally have been using axillary thermometers in the nursery; they’re more convenient and less traumatic than rectal thermometers – especially for the provider – and there’s no risk of rectal injury. Parents, however, have been told to use rectal thermometers when they take their baby home.

Lead investigator Ketan Nadkarni, MD, a 3rd-year pediatrics resident, and his colleagues wanted to compare the three methods head-to-head to make sure axillary thermometers were okay to use in the nursery, and to see if it really was necessary to tell parents to use rectal thermometers; many are reluctant to use them. Plus, “there’s been a lot of controversy” in pediatrics “over the best way to measure temperature,” Dr. Nadkarni said at the Pediatric Hospital Medicine annual meeting.

“With our data, we think axillary is what we should continue to use in the newborn nursery,” he said. Some attending physicians still are hesitant to recommend axillary thermometers to new parents, but “all of the nurses are aware of” the study findings “and a lot of the residents are, too, so I think we are starting to move” in that direction.

The study had some unexpected findings as well: “The biggest surprise was how wide the distribution of rectal temperatures was. The distribution” around the mean “was way larger than we had thought, so [rectal thermometry was] not very reliable at all. Our study surprisingly exhibited suboptimal performance in terms of reliability,” for rectal thermometry, he said at the meeting, which was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Specifically, the average distance of any given rectal measurement from the mean rectal temperature of 98.3º F was 0.45º F. The second rectal temperature in the study sometimes varied a half a degree or more from the first taken shortly before, in the same infant.

The average distance of an axillary temperature from the axillary mean of 98.32º F was 0.32º F; for temporal thermometry it was 0.34º F from a mean of 98.55º F.

Another surprise was that temporal thermometry overestimated temperature by an average of about a quarter of a degree, compared with rectal readings. Even small overestimates could lead to unnecessary sepsis work-ups; “the last thing we want is to hospitalize these kids when they don’t need to be,” Dr. Nadkarni said.

The mean axillary and rectal temperatures, meanwhile, were only 0.02º F apart, which was not statistically significant. “Axillary was absolutely interchangeable with rectal in terms of accuracy,” he said.

The children were born at 37 weeks’ gestation or later, and were excluded if they had a temperature of 100.4º F or higher by any method. Rectal and axillary temperatures were taken with a Welch Allyn SureTemp Plus 690. Temple temperatures were taken with an Exergen TAT-2000c.

The investigators plan to run a similar trial in the ED with children up to 3 months old.

There was no external funding for the work, and Dr. Nadkarni had no relevant financial disclosures.

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Key clinical point: Axillary thermometry outperforms both rectal and temporal artery thermometry in newborns.

Major finding: The average distance of an axillary temperature from the axillary mean of 98.32º F was only 0.32º F, while the average distance of any given rectal measurement from the mean rectal temperature of 98.3º F was 0.45º F, and for temporal thermometry it was 0.34º F from a mean of 98.55º F.

Data source: Head-to-head thermometry study in more than 200 infants aged 12-72 hours.

Disclosures: There was no outside funding, and Dr. Nadkarni had no relevant financial disclosures.

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Communication tools improve patient experience and satisfaction

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How hospitalists and other clinicians communicate with patients impacts a patient’s overall experience and satisfaction. But according to the authors of “Communication the Cleveland Way,”1 a book about how the clinic created and applied communication skills training, “in a culture prioritizing clinical outcomes above all, there can be a tendency to lose sight of one of the most critical aspects of providing effective care: the communication skills that build and foster physician-patient relationships.”

“Studies2,3 have shown that good communication between doctors and patients and among all caregivers who interface with patients directly results in better clinical outcomes, reduced costs, greater patient satisfaction, and lower rates of physician burnout,” the authors wrote.

Dr. Vincent Velez
In an effort to improve communication among clinicians and patients, the Cleveland Clinic’s Center for Excellence in Healthcare Communication (CEHC) created the Relationship Establishment, Development and Engagement (REDE) model. Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC, said the model is based on decades of studies on health care communication.

“It places a special focus on empathy in relationships, and in our case, the provider-patient relationship rather than patient-centered care. The former acknowledges that the thoughts and feelings in both sides of a relationship are important. We know that clinicians, too, can suffer as a result of the care they provide,” Dr. Velez wrote in “Communication the Cleveland Way.”1

“Healthy relationships are based on balance and mutual respect,” Dr Velez said. “Courses made a strong point to practice empathy in order to teach empathy. Clinician participants were gifted with a safe space, an opportunity to share their own skills and expertise, and a chance to be appreciated for what they already do effectively. Most of all, activities were designed to be fun and engaging.” For example, CEHC encouraged and fostered an attitude of exploration, experimentation, and adventure. Various warm-up activities effectively helped the participants enter a more playful space and get into character portrayal.

Dr. Velez credits the CEHC model’s sustainability and success to the early realization that an appreciative approach is effective. In a study3 about the strategy, hospital-employed attending physicians participated in the 8-hour experiential communication skills training course on REDE. The study compared approximately 1,500 “intervention” physicians who attended and 1,900 “nonintervention” physicians who did not attend.

Following the course, scores for physician communication and respect were higher for intervention physicians. Furthermore, physicians showed significant improvement in self-perceptions of empathy and burnout. Some of these gains were sustained for at least 3 months. “This is especially important because in the current health care climate, physicians experience increased burnout,” Dr. Velez notes.
 

How it works

Because a provider’s connection with a patient occurs when a relationship is established, the REDE course focuses on the beginning of the conversation. “It’s important for clinicians to exhibit value and respect through words and actions when welcoming patients,” Dr. Velez said. “Further, instead of guiding the medical interview with a series of close-ended questions like an interrogator would, we invite the use of open-ended questions and setting an agenda for the visit early on, by asking the patient what they wish to discuss.”

Another key component is empathy, which plays a huge role in patient satisfaction. “Learning how to express empathy is very important,” Dr. Velez said. “A patient may not remember all of the medical details discussed, but human interactions, rapport, expressions of care, support, validation, and acknowledgment of emotions tend to be more indelible.”

Dr. Velez notes that decades of literature regarding effective communication have demonstrated improved outcomes. “If trust in a therapeutic relationship is strong, a patient is more likely to follow instructions and have better engagement with their care plan,” he said. “If a clinician ensures that the patient understands the diagnosis and recommendations, then compliance will increase, especially if the plan is tailored to the patient’s goals and perspective.”

One surprising effect of the REDE course was how it improved relationships among professionals. “Many participants have shared that having a day out of one’s normal schedule, not only to learn, but also to share their own experiences, is quite therapeutic,” Dr. Velez said. “We can extend the same communication strategies to team building, interprofessional interactions, and challenging encounters.”
 

Study focuses on comportment and communication

In an effort to define optimal care in hospital medicine, a team from Johns Hopkins Health System set out to establish a metric that would comprehensively assess hospitalists’ comportment (which includes behavior as well as general demeanor) and communication to establish norms and expectations when they saw patients at the bedside.

 

 

To perform the study,4 chiefs of hospital medicine divisions at five independent hospitals located in Baltimore and Washington identified their most clinically excellent hospitalists. Then, an investigator observed each hospitalist during a routine clinical shift and recorded behaviors believed to be associated with excellent behavior and communication using the hospital medicine comportment and communication observation tool (HMCCOT), said Susrutha Kotwal, MD, assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, and lead author. The investigators collected basic demographic information while observing hospitalists for an average of 280 minutes; 26 physicians were observed for 181 separate clinical encounters. Each provider’s mean HMCCOT score was compared with patient satisfaction surveys such as Press Ganey (PG) scores.

Dr. Susrutha Kotwal
The most frequently observed behaviors were physicians washing their hands after leaving the patient’s room in 170 (94%) of the encounters and smiling (83%), according to the study’s results. Behaviors that were observed with the least regularity included using an empathic statement (26% of encounters), and employing teach back (13% of encounters). “Teach back” refers to asking patients what they have learned during their visit. They use their own words to explain what they should know about their health, or what they need to do to get better. A common method of demonstrating interest in the patient as a person, seen in 41% of encounters, involved physicians asking about patients’ personal histories and their interests.

Noteworthy is the fact that the distribution of HMCCOT scores were similar when analyzed by age, gender, race, amount of clinical experience, the hospitalist’s clinical workload, hospital, or time spent observing the hospitalist. But the distribution of HMCCOT scores was quite different in new patient encounters, compared with follow-ups (68.1% versus 39.7%). Encounters with patients that generated HMCCOT scores above versus below the mean were longer (13 minutes versus 8.7 minutes). The physicians’ HMCCOT scores were also associated with their PG scores. These findings suggest that improved bedside communication and comportment with patients might also translate into enhanced patient satisfaction.

As a result of the study, a comportment and communication tool was established and validated by following clinically excellent hospitalists at the bedside. “Even among clinically respected hospitalists, the results reveal that there is wide variability in behaviors and communication practices at the bedside,” Dr. Kotwal said.
 

Employing the tool

Hospitalists can choose whether to perform behaviors in the HMCCOT themselves, while others may wish to watch other hospitalists to give them feedback tied to specific behaviors. “These simple behaviors are intimately linked to excellent communication and comportment, which can serve as the foundation for delivering patient-centered care,” Dr. Kotwal said.

A positive correlation was found between spending more time with patients and higher HMCCOT scores. “Patients’ complaints about doctors often relate to feeling rushed, that their physicians did not listen to them, or that they did not convey information in a clear manner,” Dr. Kotwal said. “When successfully achieved, patient-centered communication has been associated with improved clinical outcomes, including adherence to recommended treatment and better self-management of chronic disease. Many of the components of the HMCCOT described in our study are at the heart of patient-centered care.”

Dr. Kotwal believes HMCCOT is a better strategy to improve patient satisfaction than patient satisfaction surveys because patients can’t always recall which specific provider saw them. In addition, patients’ recall about the provider may be poor because surveys are sent to patients days after they return home. In addition, patients’ recovery and health outcomes are likely to influence their assessment of the doctor. Finally, feedback is known to be most valuable and transformative when it is specific and given in real time. Therefore, a tool that is able to provide feedback at the encounter level should be more helpful than a tool that offers assessment at the level of the admission, particularly when it can be also delivered immediately after the data are collected.5

The study authors conclude that, “Future studies are necessary to determine whether hospitalists of all levels of experience and clinical skill can improve when given data and feedback using the HMCCOT. Larger studies are then needed to assess whether enhancing comportment and communication can truly improve patient satisfaction and clinical outcomes in the hospital. Because hospitalists spend only a small proportion of their clinical time in direct patient care, it is imperative that excellent comportment and communication be established as a goal for every encounter.”
 

The effectiveness of care team rounds at the bedside

Investigators at the UMass Memorial Medical Center, in Worcester, Mass., studied the effectiveness of assembling the entire care team (i.e., physicians, including residents and attendings, nursing, and clinical pharmacy) to round at the patient’s bedside each morning – in lieu of its traditionally separate rounding strategies – on one unit of its academic hospitalist service for an internal quality program, said Patricia Seymour, MD, FAAFP, assistant professor and family medicine hospitalist education director.

 

 

Additionally, academic presentations and discussions were all done in front of patients and their families (with a few exceptions) rather than traditional hallway rounds or sit rounds. Over the course of the project, the hospital also offered residents training around physician behaviors that improve patient satisfaction; provided incentives for nurses and residents to work as a team; and created a welcome visit template for the nursing manager and instruments for patients to enhance engagement. Through all of these cycles, the collaborative rounding strategy continued.

Because Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores yielded low response rates for the singular test unit and service, the investigators used a validated patient satisfaction instrument and surveyed patients from the intervention group and patients on the same unit who did not experience this collaborative rounding on their day of discharge. The intervention group had higher satisfaction scores at most of the time points. The unit-based HCAHPS scores (not just study patients) improved during this time period.

“We think the strategy of collaborative rounding yielded positive results for obvious reasons – the entire team was on the same page and the information given to the patient was consistent,” said Dr. Seymour, who notes that the study’s findings weren’t published and the project was completed for an internal quality program. “Doctors had an increased understanding about nursing concerns and the nursing staff expressed improved understanding of patients’ care plans.”

Certainly, face time with the patient was extended because much of the academic discussion occurred at the bedside instead of at another physical location without patient awareness, Dr. Seymour said. She believes the strategy boosted patient satisfaction because it was patient centered. “While this rounding strategy is not the most convenient rounding strategy for nurses or doctors, it consolidates the discussion about the patient’s clinical condition and the plan for the day. The patient experiences a strong sense of being cared for by a unified team and receives consistent messaging,” she said.

Also noteworthy is that job satisfaction for residents and nurses improved on the unit over the study time period because of the expected collaboration that was built into the work flow.

Although the facility is no longer using this communication strategy to the same degree, teaching attendings have seen the value of true bedside rounding and continue to teach this skill to learners. “We have had some challenges with geographic cohorting at our institution, which is essential for this type of team-based strategy,” Dr. Seymour said. “Sustainability requires constant encouragement, oversight, and auditing from team leaders which is also challenging and fluctuates with competing demands.”

The results of this study, and others, show that employing tools to improve communication can also result in improved patient satisfaction and experience.

Karen Appold is a medical writer in Pennsylvania.

References

1. Boissy A, Gilligan T. “Communication the Cleveland Clinic Way: How to drive a relationship-centered strategy for superior patient experience.” New York: McGraw-Hill Education. 2016.

2. Weng HC, Hung CM, Liu YT, et al. Associations between emotional intelligence and doctor burnout, job satisfaction and patient satisfaction. Med Educ. 2011;45:835-42.

3. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016 Jul;31(7):755-761. doi: 10.1007/s11606-016-3597-2. Epub 2016 Feb 26.

4. Kotwal S, Khaliq W, Landis R, Wright S. Developing a comportment and communication tool for use in hospital medicine. J Hosp Med. 2016 Dec;11(12):853-858. doi: 10.1002/jhm.2647. Epub 2016 Aug 13.

5. Fong Ha J, Longnecker N. Doctor-patient communication: a review. Ochsner J. 2010 Spring; 10(1):38-43.

6. Bodenheimer T, Sinsky C. From Triple to Quadruple Aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov;12(6): 573-6. doi: 10.1370/afm.1713.

 

Bonus Content

Clinicians wary of course's worthiness

Before clinicians took Cleveland Clinic’s Relationship Establishment, Development, and Engagement (REDE) course, only 20% strongly agreed that the course would be valuable, whereas afterward 58% strongly agreed that it was indeed valuable. Less than 1% said it wasn’t valuable.4 “Most likely clinicians had a preconceived notion about how communication courses go, but they were probably surprised at how much these sessions were equally about them as providers as they were about caring for patients,” said Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC. “This is the power of relationship-centered care, and also why I think the model has been sustainable.”

Physicians also reported that before taking the course, they had moderate levels of burnout and low levels of empathy. After taking it, burnout metrics (i.e., emotional exhaustion, depersonalization, and personal achievement) and empathy improved significantly. “I observed that most are surprised to find out that empathy is a discreet set of skills that can be learned, practiced, observed, measured, and improved upon,” Dr. Velez said. “If taught in a safe and validating environment and if principles of adult learning are followed, improvement can be optimized and sustained.”

Since the REDE course rolled out in 2012, all attending physicians and medical staff members have been trained in it.
 

Why empathy is preferred over patient-centered care

 

 

The Cleveland Clinic intentionally puts a focus on relationship-centered care.

“When there’s an emphasis on patient-centered care, some physicians have a hard time figuring out what to do when the patient wants something that the physician doesn’t feel is appropriate,” said Katie Neuendorf, MD, director for the Center for Excellence in Healthcare Communication. “Patient-centered implies that the patient is always right and that their opinion should win out over the physician’s opinion. In that same scenario, relationship-centered care implies that the relationship should be prioritized, even when there’s disagreement in the plan of care. I can tell my patients that I hear what they are saying, that I empathize with their struggles, that I care about the way the illness is affecting their lives, and that I am here to support them. I can do all of that and still not prescribe a treatment that I feel is inappropriate just because it happens to be what the patient wants.”

Dr. Kathleen Neuendorf
The development of a relationship between the patient and the physician has benefits for the physician, such as decreased rates of burnout, as well as better health outcomes for the patient, according to the results of several studies.3,5 Given these benefits, in 2014, two physicians advocated for a Quadruple Aim to replace the standard Triple Aim.6 “The Quadruple Aim recognizes that improving health care providers’ work life is imperative in keeping health care functioning,” Dr. Neuendorf said.

The Cleveland Clinic’s Relationship Establishment, Development and Engagement (REDE) course helps clinicians to see the individual that exists beyond a diagnosis. “Having empathy, or putting yourself in the other person’s shoes, is a key step in that process,” Dr. Neuendorf said. “Once a physician understands the patient’s perspective, the treatment for the diagnosis is more meaningful to both the patient and physician. Finding meaning in their work addresses the Quadruple Aim.”

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How hospitalists and other clinicians communicate with patients impacts a patient’s overall experience and satisfaction. But according to the authors of “Communication the Cleveland Way,”1 a book about how the clinic created and applied communication skills training, “in a culture prioritizing clinical outcomes above all, there can be a tendency to lose sight of one of the most critical aspects of providing effective care: the communication skills that build and foster physician-patient relationships.”

“Studies2,3 have shown that good communication between doctors and patients and among all caregivers who interface with patients directly results in better clinical outcomes, reduced costs, greater patient satisfaction, and lower rates of physician burnout,” the authors wrote.

Dr. Vincent Velez
In an effort to improve communication among clinicians and patients, the Cleveland Clinic’s Center for Excellence in Healthcare Communication (CEHC) created the Relationship Establishment, Development and Engagement (REDE) model. Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC, said the model is based on decades of studies on health care communication.

“It places a special focus on empathy in relationships, and in our case, the provider-patient relationship rather than patient-centered care. The former acknowledges that the thoughts and feelings in both sides of a relationship are important. We know that clinicians, too, can suffer as a result of the care they provide,” Dr. Velez wrote in “Communication the Cleveland Way.”1

“Healthy relationships are based on balance and mutual respect,” Dr Velez said. “Courses made a strong point to practice empathy in order to teach empathy. Clinician participants were gifted with a safe space, an opportunity to share their own skills and expertise, and a chance to be appreciated for what they already do effectively. Most of all, activities were designed to be fun and engaging.” For example, CEHC encouraged and fostered an attitude of exploration, experimentation, and adventure. Various warm-up activities effectively helped the participants enter a more playful space and get into character portrayal.

Dr. Velez credits the CEHC model’s sustainability and success to the early realization that an appreciative approach is effective. In a study3 about the strategy, hospital-employed attending physicians participated in the 8-hour experiential communication skills training course on REDE. The study compared approximately 1,500 “intervention” physicians who attended and 1,900 “nonintervention” physicians who did not attend.

Following the course, scores for physician communication and respect were higher for intervention physicians. Furthermore, physicians showed significant improvement in self-perceptions of empathy and burnout. Some of these gains were sustained for at least 3 months. “This is especially important because in the current health care climate, physicians experience increased burnout,” Dr. Velez notes.
 

How it works

Because a provider’s connection with a patient occurs when a relationship is established, the REDE course focuses on the beginning of the conversation. “It’s important for clinicians to exhibit value and respect through words and actions when welcoming patients,” Dr. Velez said. “Further, instead of guiding the medical interview with a series of close-ended questions like an interrogator would, we invite the use of open-ended questions and setting an agenda for the visit early on, by asking the patient what they wish to discuss.”

Another key component is empathy, which plays a huge role in patient satisfaction. “Learning how to express empathy is very important,” Dr. Velez said. “A patient may not remember all of the medical details discussed, but human interactions, rapport, expressions of care, support, validation, and acknowledgment of emotions tend to be more indelible.”

Dr. Velez notes that decades of literature regarding effective communication have demonstrated improved outcomes. “If trust in a therapeutic relationship is strong, a patient is more likely to follow instructions and have better engagement with their care plan,” he said. “If a clinician ensures that the patient understands the diagnosis and recommendations, then compliance will increase, especially if the plan is tailored to the patient’s goals and perspective.”

One surprising effect of the REDE course was how it improved relationships among professionals. “Many participants have shared that having a day out of one’s normal schedule, not only to learn, but also to share their own experiences, is quite therapeutic,” Dr. Velez said. “We can extend the same communication strategies to team building, interprofessional interactions, and challenging encounters.”
 

Study focuses on comportment and communication

In an effort to define optimal care in hospital medicine, a team from Johns Hopkins Health System set out to establish a metric that would comprehensively assess hospitalists’ comportment (which includes behavior as well as general demeanor) and communication to establish norms and expectations when they saw patients at the bedside.

 

 

To perform the study,4 chiefs of hospital medicine divisions at five independent hospitals located in Baltimore and Washington identified their most clinically excellent hospitalists. Then, an investigator observed each hospitalist during a routine clinical shift and recorded behaviors believed to be associated with excellent behavior and communication using the hospital medicine comportment and communication observation tool (HMCCOT), said Susrutha Kotwal, MD, assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, and lead author. The investigators collected basic demographic information while observing hospitalists for an average of 280 minutes; 26 physicians were observed for 181 separate clinical encounters. Each provider’s mean HMCCOT score was compared with patient satisfaction surveys such as Press Ganey (PG) scores.

Dr. Susrutha Kotwal
The most frequently observed behaviors were physicians washing their hands after leaving the patient’s room in 170 (94%) of the encounters and smiling (83%), according to the study’s results. Behaviors that were observed with the least regularity included using an empathic statement (26% of encounters), and employing teach back (13% of encounters). “Teach back” refers to asking patients what they have learned during their visit. They use their own words to explain what they should know about their health, or what they need to do to get better. A common method of demonstrating interest in the patient as a person, seen in 41% of encounters, involved physicians asking about patients’ personal histories and their interests.

Noteworthy is the fact that the distribution of HMCCOT scores were similar when analyzed by age, gender, race, amount of clinical experience, the hospitalist’s clinical workload, hospital, or time spent observing the hospitalist. But the distribution of HMCCOT scores was quite different in new patient encounters, compared with follow-ups (68.1% versus 39.7%). Encounters with patients that generated HMCCOT scores above versus below the mean were longer (13 minutes versus 8.7 minutes). The physicians’ HMCCOT scores were also associated with their PG scores. These findings suggest that improved bedside communication and comportment with patients might also translate into enhanced patient satisfaction.

As a result of the study, a comportment and communication tool was established and validated by following clinically excellent hospitalists at the bedside. “Even among clinically respected hospitalists, the results reveal that there is wide variability in behaviors and communication practices at the bedside,” Dr. Kotwal said.
 

Employing the tool

Hospitalists can choose whether to perform behaviors in the HMCCOT themselves, while others may wish to watch other hospitalists to give them feedback tied to specific behaviors. “These simple behaviors are intimately linked to excellent communication and comportment, which can serve as the foundation for delivering patient-centered care,” Dr. Kotwal said.

A positive correlation was found between spending more time with patients and higher HMCCOT scores. “Patients’ complaints about doctors often relate to feeling rushed, that their physicians did not listen to them, or that they did not convey information in a clear manner,” Dr. Kotwal said. “When successfully achieved, patient-centered communication has been associated with improved clinical outcomes, including adherence to recommended treatment and better self-management of chronic disease. Many of the components of the HMCCOT described in our study are at the heart of patient-centered care.”

Dr. Kotwal believes HMCCOT is a better strategy to improve patient satisfaction than patient satisfaction surveys because patients can’t always recall which specific provider saw them. In addition, patients’ recall about the provider may be poor because surveys are sent to patients days after they return home. In addition, patients’ recovery and health outcomes are likely to influence their assessment of the doctor. Finally, feedback is known to be most valuable and transformative when it is specific and given in real time. Therefore, a tool that is able to provide feedback at the encounter level should be more helpful than a tool that offers assessment at the level of the admission, particularly when it can be also delivered immediately after the data are collected.5

The study authors conclude that, “Future studies are necessary to determine whether hospitalists of all levels of experience and clinical skill can improve when given data and feedback using the HMCCOT. Larger studies are then needed to assess whether enhancing comportment and communication can truly improve patient satisfaction and clinical outcomes in the hospital. Because hospitalists spend only a small proportion of their clinical time in direct patient care, it is imperative that excellent comportment and communication be established as a goal for every encounter.”
 

The effectiveness of care team rounds at the bedside

Investigators at the UMass Memorial Medical Center, in Worcester, Mass., studied the effectiveness of assembling the entire care team (i.e., physicians, including residents and attendings, nursing, and clinical pharmacy) to round at the patient’s bedside each morning – in lieu of its traditionally separate rounding strategies – on one unit of its academic hospitalist service for an internal quality program, said Patricia Seymour, MD, FAAFP, assistant professor and family medicine hospitalist education director.

 

 

Additionally, academic presentations and discussions were all done in front of patients and their families (with a few exceptions) rather than traditional hallway rounds or sit rounds. Over the course of the project, the hospital also offered residents training around physician behaviors that improve patient satisfaction; provided incentives for nurses and residents to work as a team; and created a welcome visit template for the nursing manager and instruments for patients to enhance engagement. Through all of these cycles, the collaborative rounding strategy continued.

Because Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores yielded low response rates for the singular test unit and service, the investigators used a validated patient satisfaction instrument and surveyed patients from the intervention group and patients on the same unit who did not experience this collaborative rounding on their day of discharge. The intervention group had higher satisfaction scores at most of the time points. The unit-based HCAHPS scores (not just study patients) improved during this time period.

“We think the strategy of collaborative rounding yielded positive results for obvious reasons – the entire team was on the same page and the information given to the patient was consistent,” said Dr. Seymour, who notes that the study’s findings weren’t published and the project was completed for an internal quality program. “Doctors had an increased understanding about nursing concerns and the nursing staff expressed improved understanding of patients’ care plans.”

Certainly, face time with the patient was extended because much of the academic discussion occurred at the bedside instead of at another physical location without patient awareness, Dr. Seymour said. She believes the strategy boosted patient satisfaction because it was patient centered. “While this rounding strategy is not the most convenient rounding strategy for nurses or doctors, it consolidates the discussion about the patient’s clinical condition and the plan for the day. The patient experiences a strong sense of being cared for by a unified team and receives consistent messaging,” she said.

Also noteworthy is that job satisfaction for residents and nurses improved on the unit over the study time period because of the expected collaboration that was built into the work flow.

Although the facility is no longer using this communication strategy to the same degree, teaching attendings have seen the value of true bedside rounding and continue to teach this skill to learners. “We have had some challenges with geographic cohorting at our institution, which is essential for this type of team-based strategy,” Dr. Seymour said. “Sustainability requires constant encouragement, oversight, and auditing from team leaders which is also challenging and fluctuates with competing demands.”

The results of this study, and others, show that employing tools to improve communication can also result in improved patient satisfaction and experience.

Karen Appold is a medical writer in Pennsylvania.

References

1. Boissy A, Gilligan T. “Communication the Cleveland Clinic Way: How to drive a relationship-centered strategy for superior patient experience.” New York: McGraw-Hill Education. 2016.

2. Weng HC, Hung CM, Liu YT, et al. Associations between emotional intelligence and doctor burnout, job satisfaction and patient satisfaction. Med Educ. 2011;45:835-42.

3. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016 Jul;31(7):755-761. doi: 10.1007/s11606-016-3597-2. Epub 2016 Feb 26.

4. Kotwal S, Khaliq W, Landis R, Wright S. Developing a comportment and communication tool for use in hospital medicine. J Hosp Med. 2016 Dec;11(12):853-858. doi: 10.1002/jhm.2647. Epub 2016 Aug 13.

5. Fong Ha J, Longnecker N. Doctor-patient communication: a review. Ochsner J. 2010 Spring; 10(1):38-43.

6. Bodenheimer T, Sinsky C. From Triple to Quadruple Aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov;12(6): 573-6. doi: 10.1370/afm.1713.

 

Bonus Content

Clinicians wary of course's worthiness

Before clinicians took Cleveland Clinic’s Relationship Establishment, Development, and Engagement (REDE) course, only 20% strongly agreed that the course would be valuable, whereas afterward 58% strongly agreed that it was indeed valuable. Less than 1% said it wasn’t valuable.4 “Most likely clinicians had a preconceived notion about how communication courses go, but they were probably surprised at how much these sessions were equally about them as providers as they were about caring for patients,” said Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC. “This is the power of relationship-centered care, and also why I think the model has been sustainable.”

Physicians also reported that before taking the course, they had moderate levels of burnout and low levels of empathy. After taking it, burnout metrics (i.e., emotional exhaustion, depersonalization, and personal achievement) and empathy improved significantly. “I observed that most are surprised to find out that empathy is a discreet set of skills that can be learned, practiced, observed, measured, and improved upon,” Dr. Velez said. “If taught in a safe and validating environment and if principles of adult learning are followed, improvement can be optimized and sustained.”

Since the REDE course rolled out in 2012, all attending physicians and medical staff members have been trained in it.
 

Why empathy is preferred over patient-centered care

 

 

The Cleveland Clinic intentionally puts a focus on relationship-centered care.

“When there’s an emphasis on patient-centered care, some physicians have a hard time figuring out what to do when the patient wants something that the physician doesn’t feel is appropriate,” said Katie Neuendorf, MD, director for the Center for Excellence in Healthcare Communication. “Patient-centered implies that the patient is always right and that their opinion should win out over the physician’s opinion. In that same scenario, relationship-centered care implies that the relationship should be prioritized, even when there’s disagreement in the plan of care. I can tell my patients that I hear what they are saying, that I empathize with their struggles, that I care about the way the illness is affecting their lives, and that I am here to support them. I can do all of that and still not prescribe a treatment that I feel is inappropriate just because it happens to be what the patient wants.”

Dr. Kathleen Neuendorf
The development of a relationship between the patient and the physician has benefits for the physician, such as decreased rates of burnout, as well as better health outcomes for the patient, according to the results of several studies.3,5 Given these benefits, in 2014, two physicians advocated for a Quadruple Aim to replace the standard Triple Aim.6 “The Quadruple Aim recognizes that improving health care providers’ work life is imperative in keeping health care functioning,” Dr. Neuendorf said.

The Cleveland Clinic’s Relationship Establishment, Development and Engagement (REDE) course helps clinicians to see the individual that exists beyond a diagnosis. “Having empathy, or putting yourself in the other person’s shoes, is a key step in that process,” Dr. Neuendorf said. “Once a physician understands the patient’s perspective, the treatment for the diagnosis is more meaningful to both the patient and physician. Finding meaning in their work addresses the Quadruple Aim.”

 

How hospitalists and other clinicians communicate with patients impacts a patient’s overall experience and satisfaction. But according to the authors of “Communication the Cleveland Way,”1 a book about how the clinic created and applied communication skills training, “in a culture prioritizing clinical outcomes above all, there can be a tendency to lose sight of one of the most critical aspects of providing effective care: the communication skills that build and foster physician-patient relationships.”

“Studies2,3 have shown that good communication between doctors and patients and among all caregivers who interface with patients directly results in better clinical outcomes, reduced costs, greater patient satisfaction, and lower rates of physician burnout,” the authors wrote.

Dr. Vincent Velez
In an effort to improve communication among clinicians and patients, the Cleveland Clinic’s Center for Excellence in Healthcare Communication (CEHC) created the Relationship Establishment, Development and Engagement (REDE) model. Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC, said the model is based on decades of studies on health care communication.

“It places a special focus on empathy in relationships, and in our case, the provider-patient relationship rather than patient-centered care. The former acknowledges that the thoughts and feelings in both sides of a relationship are important. We know that clinicians, too, can suffer as a result of the care they provide,” Dr. Velez wrote in “Communication the Cleveland Way.”1

“Healthy relationships are based on balance and mutual respect,” Dr Velez said. “Courses made a strong point to practice empathy in order to teach empathy. Clinician participants were gifted with a safe space, an opportunity to share their own skills and expertise, and a chance to be appreciated for what they already do effectively. Most of all, activities were designed to be fun and engaging.” For example, CEHC encouraged and fostered an attitude of exploration, experimentation, and adventure. Various warm-up activities effectively helped the participants enter a more playful space and get into character portrayal.

Dr. Velez credits the CEHC model’s sustainability and success to the early realization that an appreciative approach is effective. In a study3 about the strategy, hospital-employed attending physicians participated in the 8-hour experiential communication skills training course on REDE. The study compared approximately 1,500 “intervention” physicians who attended and 1,900 “nonintervention” physicians who did not attend.

Following the course, scores for physician communication and respect were higher for intervention physicians. Furthermore, physicians showed significant improvement in self-perceptions of empathy and burnout. Some of these gains were sustained for at least 3 months. “This is especially important because in the current health care climate, physicians experience increased burnout,” Dr. Velez notes.
 

How it works

Because a provider’s connection with a patient occurs when a relationship is established, the REDE course focuses on the beginning of the conversation. “It’s important for clinicians to exhibit value and respect through words and actions when welcoming patients,” Dr. Velez said. “Further, instead of guiding the medical interview with a series of close-ended questions like an interrogator would, we invite the use of open-ended questions and setting an agenda for the visit early on, by asking the patient what they wish to discuss.”

Another key component is empathy, which plays a huge role in patient satisfaction. “Learning how to express empathy is very important,” Dr. Velez said. “A patient may not remember all of the medical details discussed, but human interactions, rapport, expressions of care, support, validation, and acknowledgment of emotions tend to be more indelible.”

Dr. Velez notes that decades of literature regarding effective communication have demonstrated improved outcomes. “If trust in a therapeutic relationship is strong, a patient is more likely to follow instructions and have better engagement with their care plan,” he said. “If a clinician ensures that the patient understands the diagnosis and recommendations, then compliance will increase, especially if the plan is tailored to the patient’s goals and perspective.”

One surprising effect of the REDE course was how it improved relationships among professionals. “Many participants have shared that having a day out of one’s normal schedule, not only to learn, but also to share their own experiences, is quite therapeutic,” Dr. Velez said. “We can extend the same communication strategies to team building, interprofessional interactions, and challenging encounters.”
 

Study focuses on comportment and communication

In an effort to define optimal care in hospital medicine, a team from Johns Hopkins Health System set out to establish a metric that would comprehensively assess hospitalists’ comportment (which includes behavior as well as general demeanor) and communication to establish norms and expectations when they saw patients at the bedside.

 

 

To perform the study,4 chiefs of hospital medicine divisions at five independent hospitals located in Baltimore and Washington identified their most clinically excellent hospitalists. Then, an investigator observed each hospitalist during a routine clinical shift and recorded behaviors believed to be associated with excellent behavior and communication using the hospital medicine comportment and communication observation tool (HMCCOT), said Susrutha Kotwal, MD, assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, and lead author. The investigators collected basic demographic information while observing hospitalists for an average of 280 minutes; 26 physicians were observed for 181 separate clinical encounters. Each provider’s mean HMCCOT score was compared with patient satisfaction surveys such as Press Ganey (PG) scores.

Dr. Susrutha Kotwal
The most frequently observed behaviors were physicians washing their hands after leaving the patient’s room in 170 (94%) of the encounters and smiling (83%), according to the study’s results. Behaviors that were observed with the least regularity included using an empathic statement (26% of encounters), and employing teach back (13% of encounters). “Teach back” refers to asking patients what they have learned during their visit. They use their own words to explain what they should know about their health, or what they need to do to get better. A common method of demonstrating interest in the patient as a person, seen in 41% of encounters, involved physicians asking about patients’ personal histories and their interests.

Noteworthy is the fact that the distribution of HMCCOT scores were similar when analyzed by age, gender, race, amount of clinical experience, the hospitalist’s clinical workload, hospital, or time spent observing the hospitalist. But the distribution of HMCCOT scores was quite different in new patient encounters, compared with follow-ups (68.1% versus 39.7%). Encounters with patients that generated HMCCOT scores above versus below the mean were longer (13 minutes versus 8.7 minutes). The physicians’ HMCCOT scores were also associated with their PG scores. These findings suggest that improved bedside communication and comportment with patients might also translate into enhanced patient satisfaction.

As a result of the study, a comportment and communication tool was established and validated by following clinically excellent hospitalists at the bedside. “Even among clinically respected hospitalists, the results reveal that there is wide variability in behaviors and communication practices at the bedside,” Dr. Kotwal said.
 

Employing the tool

Hospitalists can choose whether to perform behaviors in the HMCCOT themselves, while others may wish to watch other hospitalists to give them feedback tied to specific behaviors. “These simple behaviors are intimately linked to excellent communication and comportment, which can serve as the foundation for delivering patient-centered care,” Dr. Kotwal said.

A positive correlation was found between spending more time with patients and higher HMCCOT scores. “Patients’ complaints about doctors often relate to feeling rushed, that their physicians did not listen to them, or that they did not convey information in a clear manner,” Dr. Kotwal said. “When successfully achieved, patient-centered communication has been associated with improved clinical outcomes, including adherence to recommended treatment and better self-management of chronic disease. Many of the components of the HMCCOT described in our study are at the heart of patient-centered care.”

Dr. Kotwal believes HMCCOT is a better strategy to improve patient satisfaction than patient satisfaction surveys because patients can’t always recall which specific provider saw them. In addition, patients’ recall about the provider may be poor because surveys are sent to patients days after they return home. In addition, patients’ recovery and health outcomes are likely to influence their assessment of the doctor. Finally, feedback is known to be most valuable and transformative when it is specific and given in real time. Therefore, a tool that is able to provide feedback at the encounter level should be more helpful than a tool that offers assessment at the level of the admission, particularly when it can be also delivered immediately after the data are collected.5

The study authors conclude that, “Future studies are necessary to determine whether hospitalists of all levels of experience and clinical skill can improve when given data and feedback using the HMCCOT. Larger studies are then needed to assess whether enhancing comportment and communication can truly improve patient satisfaction and clinical outcomes in the hospital. Because hospitalists spend only a small proportion of their clinical time in direct patient care, it is imperative that excellent comportment and communication be established as a goal for every encounter.”
 

The effectiveness of care team rounds at the bedside

Investigators at the UMass Memorial Medical Center, in Worcester, Mass., studied the effectiveness of assembling the entire care team (i.e., physicians, including residents and attendings, nursing, and clinical pharmacy) to round at the patient’s bedside each morning – in lieu of its traditionally separate rounding strategies – on one unit of its academic hospitalist service for an internal quality program, said Patricia Seymour, MD, FAAFP, assistant professor and family medicine hospitalist education director.

 

 

Additionally, academic presentations and discussions were all done in front of patients and their families (with a few exceptions) rather than traditional hallway rounds or sit rounds. Over the course of the project, the hospital also offered residents training around physician behaviors that improve patient satisfaction; provided incentives for nurses and residents to work as a team; and created a welcome visit template for the nursing manager and instruments for patients to enhance engagement. Through all of these cycles, the collaborative rounding strategy continued.

Because Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores yielded low response rates for the singular test unit and service, the investigators used a validated patient satisfaction instrument and surveyed patients from the intervention group and patients on the same unit who did not experience this collaborative rounding on their day of discharge. The intervention group had higher satisfaction scores at most of the time points. The unit-based HCAHPS scores (not just study patients) improved during this time period.

“We think the strategy of collaborative rounding yielded positive results for obvious reasons – the entire team was on the same page and the information given to the patient was consistent,” said Dr. Seymour, who notes that the study’s findings weren’t published and the project was completed for an internal quality program. “Doctors had an increased understanding about nursing concerns and the nursing staff expressed improved understanding of patients’ care plans.”

Certainly, face time with the patient was extended because much of the academic discussion occurred at the bedside instead of at another physical location without patient awareness, Dr. Seymour said. She believes the strategy boosted patient satisfaction because it was patient centered. “While this rounding strategy is not the most convenient rounding strategy for nurses or doctors, it consolidates the discussion about the patient’s clinical condition and the plan for the day. The patient experiences a strong sense of being cared for by a unified team and receives consistent messaging,” she said.

Also noteworthy is that job satisfaction for residents and nurses improved on the unit over the study time period because of the expected collaboration that was built into the work flow.

Although the facility is no longer using this communication strategy to the same degree, teaching attendings have seen the value of true bedside rounding and continue to teach this skill to learners. “We have had some challenges with geographic cohorting at our institution, which is essential for this type of team-based strategy,” Dr. Seymour said. “Sustainability requires constant encouragement, oversight, and auditing from team leaders which is also challenging and fluctuates with competing demands.”

The results of this study, and others, show that employing tools to improve communication can also result in improved patient satisfaction and experience.

Karen Appold is a medical writer in Pennsylvania.

References

1. Boissy A, Gilligan T. “Communication the Cleveland Clinic Way: How to drive a relationship-centered strategy for superior patient experience.” New York: McGraw-Hill Education. 2016.

2. Weng HC, Hung CM, Liu YT, et al. Associations between emotional intelligence and doctor burnout, job satisfaction and patient satisfaction. Med Educ. 2011;45:835-42.

3. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016 Jul;31(7):755-761. doi: 10.1007/s11606-016-3597-2. Epub 2016 Feb 26.

4. Kotwal S, Khaliq W, Landis R, Wright S. Developing a comportment and communication tool for use in hospital medicine. J Hosp Med. 2016 Dec;11(12):853-858. doi: 10.1002/jhm.2647. Epub 2016 Aug 13.

5. Fong Ha J, Longnecker N. Doctor-patient communication: a review. Ochsner J. 2010 Spring; 10(1):38-43.

6. Bodenheimer T, Sinsky C. From Triple to Quadruple Aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov;12(6): 573-6. doi: 10.1370/afm.1713.

 

Bonus Content

Clinicians wary of course's worthiness

Before clinicians took Cleveland Clinic’s Relationship Establishment, Development, and Engagement (REDE) course, only 20% strongly agreed that the course would be valuable, whereas afterward 58% strongly agreed that it was indeed valuable. Less than 1% said it wasn’t valuable.4 “Most likely clinicians had a preconceived notion about how communication courses go, but they were probably surprised at how much these sessions were equally about them as providers as they were about caring for patients,” said Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC. “This is the power of relationship-centered care, and also why I think the model has been sustainable.”

Physicians also reported that before taking the course, they had moderate levels of burnout and low levels of empathy. After taking it, burnout metrics (i.e., emotional exhaustion, depersonalization, and personal achievement) and empathy improved significantly. “I observed that most are surprised to find out that empathy is a discreet set of skills that can be learned, practiced, observed, measured, and improved upon,” Dr. Velez said. “If taught in a safe and validating environment and if principles of adult learning are followed, improvement can be optimized and sustained.”

Since the REDE course rolled out in 2012, all attending physicians and medical staff members have been trained in it.
 

Why empathy is preferred over patient-centered care

 

 

The Cleveland Clinic intentionally puts a focus on relationship-centered care.

“When there’s an emphasis on patient-centered care, some physicians have a hard time figuring out what to do when the patient wants something that the physician doesn’t feel is appropriate,” said Katie Neuendorf, MD, director for the Center for Excellence in Healthcare Communication. “Patient-centered implies that the patient is always right and that their opinion should win out over the physician’s opinion. In that same scenario, relationship-centered care implies that the relationship should be prioritized, even when there’s disagreement in the plan of care. I can tell my patients that I hear what they are saying, that I empathize with their struggles, that I care about the way the illness is affecting their lives, and that I am here to support them. I can do all of that and still not prescribe a treatment that I feel is inappropriate just because it happens to be what the patient wants.”

Dr. Kathleen Neuendorf
The development of a relationship between the patient and the physician has benefits for the physician, such as decreased rates of burnout, as well as better health outcomes for the patient, according to the results of several studies.3,5 Given these benefits, in 2014, two physicians advocated for a Quadruple Aim to replace the standard Triple Aim.6 “The Quadruple Aim recognizes that improving health care providers’ work life is imperative in keeping health care functioning,” Dr. Neuendorf said.

The Cleveland Clinic’s Relationship Establishment, Development and Engagement (REDE) course helps clinicians to see the individual that exists beyond a diagnosis. “Having empathy, or putting yourself in the other person’s shoes, is a key step in that process,” Dr. Neuendorf said. “Once a physician understands the patient’s perspective, the treatment for the diagnosis is more meaningful to both the patient and physician. Finding meaning in their work addresses the Quadruple Aim.”

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Despite global decline, rheumatic heart disease persists in poorest regions

Study reveals marked disparities
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Fri, 01/18/2019 - 16:59

Global mortality due to rheumatic heart disease fell by about 48% during a recent 25-year-period, but some of the poorest areas of the world were left behind, according to a report in the New England Journal of Medicine.

Those regions included Oceania, South Asia, and central sub-Saharan Africa, where rheumatic heart disease remains endemic, wrote David A. Watkins, MD, MPH, of the University of Washington, Seattle, and his coinvestigators. “We estimate that 10 persons per 1,000 population living in South Asia and central sub-Saharan Africa and 15 persons per 1,000 population in Oceania were living with rheumatic heart disease in the year 2015,” they wrote. “Improvements in the measurement of the burden of rheumatic heart disease will assist in planning for its control and will help identify countries where further investments are needed.”

Dr. David Watkins
Rheumatic heart disease is a sequela of untreated streptococcal pharyngitis, which is associated with poverty, overcrowding, poor sanitation, and other social predictors of poor health. In high-income countries, treatment with penicillin G and improved sanitation had nearly eliminated rheumatic heart disease by the late 20th century, but local studies pointed to ongoing morbidity and mortality in lower-income regions.

To better define the problem, Dr. Watkins and his associates analyzed epidemiologic studies of rheumatic heart disease from 1990 through 2015. They used the Cause of Death Ensemble model, which estimates mortality more reliably than older methods, and DisMod-MR (version 2.1), which sums epidemiologic data from multiple sources and corrects for gaps and inconsistencies (N Engl J Med. 2017;377:713-22).

Worldwide, about 319,400 individuals died of rheumatic heart disease in 2015, the researchers reported. Age-adjusted death rates fell by about 48% (95% confidence interval, 45%-51%), from 9.2 deaths per 100,000 population in 1990 to 4.8 deaths per 100,000 population in 2015. But this global trend masked striking regional disparities. In 1990, 77% of deaths from rheumatic heart disease occurred in endemic areas of Africa, South Asia, Oceania, and the Caribbean; by 2015, 82% of deaths occurred in endemic regions. Oceania, South Asia, and central sub-Saharan Africa had the highest death rates and were the only regions where the 95% confidence intervals for 1990 and 2015 overlapped, the investigators noted.

In 2015, age-standardized death rates exceeded 10 deaths per 100,000 population in the Solomon Islands, Pakistan, Papua New Guinea, Kiribati, Vanuatu, Fiji, India, Federated States of Micronesia, Marshall Islands, Central African Republic, and Lesotho, they reported. Estimated fatalities were highest in India (119,100 deaths), China (72,600), and Pakistan (18,900). They estimated that in 2015, there were 33.2 million cases of rheumatic heart disease and 10.5 million associated disability-adjusted life-years globally.

The study excluded “borderline” or subclinical rheumatic heart disease, which is detected by echocardiography and whose management remains unclear. “Better data for low-income and middle-income countries are needed to guide policies for the control of rheumatic heart disease,” the investigators wrote. They recommended studying death certificate misclassifications, disease prevalence among adults, and longitudinal trends in nonfatal outcomes and excess mortality.

Funders of the study included the Bill and Melinda Gates Foundation and the Medtronic Foundation. Dr. Watkins disclosed grants from the Medtronic Foundation during the conduct of the study and grants from the Bill and Melinda Gates Foundation outside the submitted work.

Body

 

Rheumatic heart disease ranks as one of the most serious cardiovascular scourges of the past century. As a result of improvements in living conditions and the introduction of penicillin, the disease was almost eradicated in the developed world by the 1980s. However, it remains a force to be reckoned with in the developing world, as demonstrated by an assessment from the 2015 Global Burden of Disease study (GBD 2015), painstakingly performed by Dr. Watkins and his colleagues.

Several key messages emerge from this important study. It confirms the marked global heterogeneity of the burden of rheumatic heart disease, with near-zero prevalence in developed countries sharply contrasting with substantial prevalence and mortality in developing areas. In addition, however, the study documents the scarcity of accurately measured data in many locations, especially in areas with the highest prevalence (such as sub-Saharan Africa).

Although the “headline news” of a global decline in the prevalence of rheumatic heart disease described by Watkins et al. may give cause for optimism, the burden remains great for those parts of the world least able to afford it. Without sustained re-engagement of clinicians, researchers, funders, and public health bodies, the menace of rheumatic heart disease is unlikely to be eliminated in the near future. Rheumatic heart disease remains a problematic iceberg, yet undissolved, in warm tropical waters.

Eloi Marijon, MD, PhD, and Xavier Jouven, MD, PhD, are at European Georges Pompidou Hospital, Paris. David S. Celermajer, PhD, is at Sydney (Australia) Medical School. They reported having no conflicts of interest. Their editorial accompanied the report by Dr. Watkins and his colleagues (N Engl J Med. 2017;377:780-1).

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Rheumatic heart disease ranks as one of the most serious cardiovascular scourges of the past century. As a result of improvements in living conditions and the introduction of penicillin, the disease was almost eradicated in the developed world by the 1980s. However, it remains a force to be reckoned with in the developing world, as demonstrated by an assessment from the 2015 Global Burden of Disease study (GBD 2015), painstakingly performed by Dr. Watkins and his colleagues.

Several key messages emerge from this important study. It confirms the marked global heterogeneity of the burden of rheumatic heart disease, with near-zero prevalence in developed countries sharply contrasting with substantial prevalence and mortality in developing areas. In addition, however, the study documents the scarcity of accurately measured data in many locations, especially in areas with the highest prevalence (such as sub-Saharan Africa).

Although the “headline news” of a global decline in the prevalence of rheumatic heart disease described by Watkins et al. may give cause for optimism, the burden remains great for those parts of the world least able to afford it. Without sustained re-engagement of clinicians, researchers, funders, and public health bodies, the menace of rheumatic heart disease is unlikely to be eliminated in the near future. Rheumatic heart disease remains a problematic iceberg, yet undissolved, in warm tropical waters.

Eloi Marijon, MD, PhD, and Xavier Jouven, MD, PhD, are at European Georges Pompidou Hospital, Paris. David S. Celermajer, PhD, is at Sydney (Australia) Medical School. They reported having no conflicts of interest. Their editorial accompanied the report by Dr. Watkins and his colleagues (N Engl J Med. 2017;377:780-1).

Body

 

Rheumatic heart disease ranks as one of the most serious cardiovascular scourges of the past century. As a result of improvements in living conditions and the introduction of penicillin, the disease was almost eradicated in the developed world by the 1980s. However, it remains a force to be reckoned with in the developing world, as demonstrated by an assessment from the 2015 Global Burden of Disease study (GBD 2015), painstakingly performed by Dr. Watkins and his colleagues.

Several key messages emerge from this important study. It confirms the marked global heterogeneity of the burden of rheumatic heart disease, with near-zero prevalence in developed countries sharply contrasting with substantial prevalence and mortality in developing areas. In addition, however, the study documents the scarcity of accurately measured data in many locations, especially in areas with the highest prevalence (such as sub-Saharan Africa).

Although the “headline news” of a global decline in the prevalence of rheumatic heart disease described by Watkins et al. may give cause for optimism, the burden remains great for those parts of the world least able to afford it. Without sustained re-engagement of clinicians, researchers, funders, and public health bodies, the menace of rheumatic heart disease is unlikely to be eliminated in the near future. Rheumatic heart disease remains a problematic iceberg, yet undissolved, in warm tropical waters.

Eloi Marijon, MD, PhD, and Xavier Jouven, MD, PhD, are at European Georges Pompidou Hospital, Paris. David S. Celermajer, PhD, is at Sydney (Australia) Medical School. They reported having no conflicts of interest. Their editorial accompanied the report by Dr. Watkins and his colleagues (N Engl J Med. 2017;377:780-1).

Title
Study reveals marked disparities
Study reveals marked disparities

Global mortality due to rheumatic heart disease fell by about 48% during a recent 25-year-period, but some of the poorest areas of the world were left behind, according to a report in the New England Journal of Medicine.

Those regions included Oceania, South Asia, and central sub-Saharan Africa, where rheumatic heart disease remains endemic, wrote David A. Watkins, MD, MPH, of the University of Washington, Seattle, and his coinvestigators. “We estimate that 10 persons per 1,000 population living in South Asia and central sub-Saharan Africa and 15 persons per 1,000 population in Oceania were living with rheumatic heart disease in the year 2015,” they wrote. “Improvements in the measurement of the burden of rheumatic heart disease will assist in planning for its control and will help identify countries where further investments are needed.”

Dr. David Watkins
Rheumatic heart disease is a sequela of untreated streptococcal pharyngitis, which is associated with poverty, overcrowding, poor sanitation, and other social predictors of poor health. In high-income countries, treatment with penicillin G and improved sanitation had nearly eliminated rheumatic heart disease by the late 20th century, but local studies pointed to ongoing morbidity and mortality in lower-income regions.

To better define the problem, Dr. Watkins and his associates analyzed epidemiologic studies of rheumatic heart disease from 1990 through 2015. They used the Cause of Death Ensemble model, which estimates mortality more reliably than older methods, and DisMod-MR (version 2.1), which sums epidemiologic data from multiple sources and corrects for gaps and inconsistencies (N Engl J Med. 2017;377:713-22).

Worldwide, about 319,400 individuals died of rheumatic heart disease in 2015, the researchers reported. Age-adjusted death rates fell by about 48% (95% confidence interval, 45%-51%), from 9.2 deaths per 100,000 population in 1990 to 4.8 deaths per 100,000 population in 2015. But this global trend masked striking regional disparities. In 1990, 77% of deaths from rheumatic heart disease occurred in endemic areas of Africa, South Asia, Oceania, and the Caribbean; by 2015, 82% of deaths occurred in endemic regions. Oceania, South Asia, and central sub-Saharan Africa had the highest death rates and were the only regions where the 95% confidence intervals for 1990 and 2015 overlapped, the investigators noted.

In 2015, age-standardized death rates exceeded 10 deaths per 100,000 population in the Solomon Islands, Pakistan, Papua New Guinea, Kiribati, Vanuatu, Fiji, India, Federated States of Micronesia, Marshall Islands, Central African Republic, and Lesotho, they reported. Estimated fatalities were highest in India (119,100 deaths), China (72,600), and Pakistan (18,900). They estimated that in 2015, there were 33.2 million cases of rheumatic heart disease and 10.5 million associated disability-adjusted life-years globally.

The study excluded “borderline” or subclinical rheumatic heart disease, which is detected by echocardiography and whose management remains unclear. “Better data for low-income and middle-income countries are needed to guide policies for the control of rheumatic heart disease,” the investigators wrote. They recommended studying death certificate misclassifications, disease prevalence among adults, and longitudinal trends in nonfatal outcomes and excess mortality.

Funders of the study included the Bill and Melinda Gates Foundation and the Medtronic Foundation. Dr. Watkins disclosed grants from the Medtronic Foundation during the conduct of the study and grants from the Bill and Melinda Gates Foundation outside the submitted work.

Global mortality due to rheumatic heart disease fell by about 48% during a recent 25-year-period, but some of the poorest areas of the world were left behind, according to a report in the New England Journal of Medicine.

Those regions included Oceania, South Asia, and central sub-Saharan Africa, where rheumatic heart disease remains endemic, wrote David A. Watkins, MD, MPH, of the University of Washington, Seattle, and his coinvestigators. “We estimate that 10 persons per 1,000 population living in South Asia and central sub-Saharan Africa and 15 persons per 1,000 population in Oceania were living with rheumatic heart disease in the year 2015,” they wrote. “Improvements in the measurement of the burden of rheumatic heart disease will assist in planning for its control and will help identify countries where further investments are needed.”

Dr. David Watkins
Rheumatic heart disease is a sequela of untreated streptococcal pharyngitis, which is associated with poverty, overcrowding, poor sanitation, and other social predictors of poor health. In high-income countries, treatment with penicillin G and improved sanitation had nearly eliminated rheumatic heart disease by the late 20th century, but local studies pointed to ongoing morbidity and mortality in lower-income regions.

To better define the problem, Dr. Watkins and his associates analyzed epidemiologic studies of rheumatic heart disease from 1990 through 2015. They used the Cause of Death Ensemble model, which estimates mortality more reliably than older methods, and DisMod-MR (version 2.1), which sums epidemiologic data from multiple sources and corrects for gaps and inconsistencies (N Engl J Med. 2017;377:713-22).

Worldwide, about 319,400 individuals died of rheumatic heart disease in 2015, the researchers reported. Age-adjusted death rates fell by about 48% (95% confidence interval, 45%-51%), from 9.2 deaths per 100,000 population in 1990 to 4.8 deaths per 100,000 population in 2015. But this global trend masked striking regional disparities. In 1990, 77% of deaths from rheumatic heart disease occurred in endemic areas of Africa, South Asia, Oceania, and the Caribbean; by 2015, 82% of deaths occurred in endemic regions. Oceania, South Asia, and central sub-Saharan Africa had the highest death rates and were the only regions where the 95% confidence intervals for 1990 and 2015 overlapped, the investigators noted.

In 2015, age-standardized death rates exceeded 10 deaths per 100,000 population in the Solomon Islands, Pakistan, Papua New Guinea, Kiribati, Vanuatu, Fiji, India, Federated States of Micronesia, Marshall Islands, Central African Republic, and Lesotho, they reported. Estimated fatalities were highest in India (119,100 deaths), China (72,600), and Pakistan (18,900). They estimated that in 2015, there were 33.2 million cases of rheumatic heart disease and 10.5 million associated disability-adjusted life-years globally.

The study excluded “borderline” or subclinical rheumatic heart disease, which is detected by echocardiography and whose management remains unclear. “Better data for low-income and middle-income countries are needed to guide policies for the control of rheumatic heart disease,” the investigators wrote. They recommended studying death certificate misclassifications, disease prevalence among adults, and longitudinal trends in nonfatal outcomes and excess mortality.

Funders of the study included the Bill and Melinda Gates Foundation and the Medtronic Foundation. Dr. Watkins disclosed grants from the Medtronic Foundation during the conduct of the study and grants from the Bill and Melinda Gates Foundation outside the submitted work.

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FROM NEW ENGLAND JOURNAL OF MEDICINE

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Key clinical point: The near eradication of rheumatic heart disease in developed countries has left behind some of the world’s poorest areas.

Major finding: Globally, age-adjusted death rates fell by about 48% between 1990 and 2015. Oceania, South Asia, and central sub-Saharan Africa had the highest death rates in 2015, and were the only regions where the 95% confidence intervals overlapped with those for 1990.

Data source: A systematic review and analysis of morbidity and mortality data from 1990 through 2015.

Disclosures: Funders included the Bill and Melinda Gates Foundation and the Medtronic Foundation. Dr. Watkins disclosed grants from the Medtronic Foundation during the conduct of the study and grants from the Bill and Melinda Gates Foundation outside the submitted work.

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