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No difference between PPI prophylaxis, placebo for GI bleeding

PPI should be reserved for the “seriously ill”
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Fri, 01/18/2019 - 18:10

There was no significant difference in mortality between critically ill patients who received pantoprazole prophylaxis for gastrointestinal bleeding, and those who received placebo, new findings suggest.

In a multicenter, randomized trial of 3,298 adult patients at risk for gastrointestinal bleeding, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died at 90 days (relative risk, 1.02; 95% confidence interval, 0.91-1.13; P = .76). The results were published in the New England Journal of Medicine.

Patients were aged 18 years or older; had been admitted to the ICU for an acute condition in one of six international centers; and had at least one risk factor for gastrointestinal bleeding including shock, use of anticoagulant agents, renal replacement therapy, mechanical ventilation (expected to last more than 24 hours), any history of liver disease, or any history of or ongoing coagulopathy. A total of 1,645 patients were randomly assigned to receive 40 mg of intravenous pantoprazole once daily and 1,653 received placebo, reported Mette Krag, MD, of the department of intensive care at Rigshospitalet in Copenhagen, and her coauthors.

The primary outcome was 90-day mortality. Secondary outcomes were clinically important events in the ICU, clinically important gastrointestinal bleeding in the ICU, infectious adverse events in the ICU, and days alive without the use of life support within the 90-day period.

One or more clinically important events occurred in 21.9% of patients in the pantoprazole group and in 22.6% in the placebo group (RR, 0.96; 95% CI, 0.83-1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, compared with 4.2% in the placebo group, Dr. Krag and her coauthors wrote.

The findings are similar to other recently published results, which showed “no significant differences ... in the rates of death or infectious complications between patients receiving placebo or no prophylaxis and those receiving proton pump inhibitors,” the authors wrote.

Dr. Krag reported financial support from Innovation Fund Denmark, Ehrenreich’s Foundation, and several other organizations.

SOURCE: Krag M et al. N Engl J Med. 2018 Dec 6. doi: 10.1056/NEJMoa1714919.

This article was updated 12/6/18.

Body

“The take-home message from this trial is that, given the low incidence of clinically important upper gastrointestinal bleeding in the ICU, prophylaxis with a PPI [proton pump inhibitor], if initiated, should be reserved for seriously ill patients who are at high risk for this complication,” wrote Alan Barkun, MD, CM, of McGill University, Montreal, and Marc Bardou, MD, PhD, of the Centre Hospitalier Universitaire Dijon–Bourgogne (France), in an editorial published with the study.

Though 90-day mortality was similar between groups in this trial, “the between-group difference in the rate of important upper gastrointestinal bleeding may still support the recommendation of using a prophylactic PPI” given the absence of a difference in the rate of adverse events between the two groups, they added.

Dr. Barkun reported no disclosures; Dr. Bardou reported support from the French Medicines Agency.

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Body

“The take-home message from this trial is that, given the low incidence of clinically important upper gastrointestinal bleeding in the ICU, prophylaxis with a PPI [proton pump inhibitor], if initiated, should be reserved for seriously ill patients who are at high risk for this complication,” wrote Alan Barkun, MD, CM, of McGill University, Montreal, and Marc Bardou, MD, PhD, of the Centre Hospitalier Universitaire Dijon–Bourgogne (France), in an editorial published with the study.

Though 90-day mortality was similar between groups in this trial, “the between-group difference in the rate of important upper gastrointestinal bleeding may still support the recommendation of using a prophylactic PPI” given the absence of a difference in the rate of adverse events between the two groups, they added.

Dr. Barkun reported no disclosures; Dr. Bardou reported support from the French Medicines Agency.

Body

“The take-home message from this trial is that, given the low incidence of clinically important upper gastrointestinal bleeding in the ICU, prophylaxis with a PPI [proton pump inhibitor], if initiated, should be reserved for seriously ill patients who are at high risk for this complication,” wrote Alan Barkun, MD, CM, of McGill University, Montreal, and Marc Bardou, MD, PhD, of the Centre Hospitalier Universitaire Dijon–Bourgogne (France), in an editorial published with the study.

Though 90-day mortality was similar between groups in this trial, “the between-group difference in the rate of important upper gastrointestinal bleeding may still support the recommendation of using a prophylactic PPI” given the absence of a difference in the rate of adverse events between the two groups, they added.

Dr. Barkun reported no disclosures; Dr. Bardou reported support from the French Medicines Agency.

Title
PPI should be reserved for the “seriously ill”
PPI should be reserved for the “seriously ill”

There was no significant difference in mortality between critically ill patients who received pantoprazole prophylaxis for gastrointestinal bleeding, and those who received placebo, new findings suggest.

In a multicenter, randomized trial of 3,298 adult patients at risk for gastrointestinal bleeding, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died at 90 days (relative risk, 1.02; 95% confidence interval, 0.91-1.13; P = .76). The results were published in the New England Journal of Medicine.

Patients were aged 18 years or older; had been admitted to the ICU for an acute condition in one of six international centers; and had at least one risk factor for gastrointestinal bleeding including shock, use of anticoagulant agents, renal replacement therapy, mechanical ventilation (expected to last more than 24 hours), any history of liver disease, or any history of or ongoing coagulopathy. A total of 1,645 patients were randomly assigned to receive 40 mg of intravenous pantoprazole once daily and 1,653 received placebo, reported Mette Krag, MD, of the department of intensive care at Rigshospitalet in Copenhagen, and her coauthors.

The primary outcome was 90-day mortality. Secondary outcomes were clinically important events in the ICU, clinically important gastrointestinal bleeding in the ICU, infectious adverse events in the ICU, and days alive without the use of life support within the 90-day period.

One or more clinically important events occurred in 21.9% of patients in the pantoprazole group and in 22.6% in the placebo group (RR, 0.96; 95% CI, 0.83-1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, compared with 4.2% in the placebo group, Dr. Krag and her coauthors wrote.

The findings are similar to other recently published results, which showed “no significant differences ... in the rates of death or infectious complications between patients receiving placebo or no prophylaxis and those receiving proton pump inhibitors,” the authors wrote.

Dr. Krag reported financial support from Innovation Fund Denmark, Ehrenreich’s Foundation, and several other organizations.

SOURCE: Krag M et al. N Engl J Med. 2018 Dec 6. doi: 10.1056/NEJMoa1714919.

This article was updated 12/6/18.

There was no significant difference in mortality between critically ill patients who received pantoprazole prophylaxis for gastrointestinal bleeding, and those who received placebo, new findings suggest.

In a multicenter, randomized trial of 3,298 adult patients at risk for gastrointestinal bleeding, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died at 90 days (relative risk, 1.02; 95% confidence interval, 0.91-1.13; P = .76). The results were published in the New England Journal of Medicine.

Patients were aged 18 years or older; had been admitted to the ICU for an acute condition in one of six international centers; and had at least one risk factor for gastrointestinal bleeding including shock, use of anticoagulant agents, renal replacement therapy, mechanical ventilation (expected to last more than 24 hours), any history of liver disease, or any history of or ongoing coagulopathy. A total of 1,645 patients were randomly assigned to receive 40 mg of intravenous pantoprazole once daily and 1,653 received placebo, reported Mette Krag, MD, of the department of intensive care at Rigshospitalet in Copenhagen, and her coauthors.

The primary outcome was 90-day mortality. Secondary outcomes were clinically important events in the ICU, clinically important gastrointestinal bleeding in the ICU, infectious adverse events in the ICU, and days alive without the use of life support within the 90-day period.

One or more clinically important events occurred in 21.9% of patients in the pantoprazole group and in 22.6% in the placebo group (RR, 0.96; 95% CI, 0.83-1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, compared with 4.2% in the placebo group, Dr. Krag and her coauthors wrote.

The findings are similar to other recently published results, which showed “no significant differences ... in the rates of death or infectious complications between patients receiving placebo or no prophylaxis and those receiving proton pump inhibitors,” the authors wrote.

Dr. Krag reported financial support from Innovation Fund Denmark, Ehrenreich’s Foundation, and several other organizations.

SOURCE: Krag M et al. N Engl J Med. 2018 Dec 6. doi: 10.1056/NEJMoa1714919.

This article was updated 12/6/18.

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Key clinical point: There was no significant difference in mortality between patients who received pantoprazole prophylaxis for gastrointestinal bleeding, and those who received placebo.

Major finding: Just over 31% of patients in the pantoprazole group and 30.4% in the placebo group had died at 90 days (relative risk, 1.02; 95% confidence interval, 0.91-1.13; P = .76).

Study details: A multicenter, randomized trial of 3,298 adult ICU patients at risk for gastrointestinal bleeding.

Disclosures: Dr. Krag reported financial support from Innovation Fund Denmark, Ehrenreich’s Foundation, and several other organizations.

Source: Krag M et al. N Engl J Med. 2018 Dec 6. doi: 10.1056/NEJMoa1714919.

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ONC releases draft strategy on reducing EHR burden

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A new federal proposal aims to move you away from the keyboard and back face-to-face with your patients.

Dr. Kate Goodrich

The draft strategy from the Office of the National Coordinator for Health IT has three aims: to reduce the time and effort to record information in EHRs; to reduce the time and effort required to meet regulatory requirements; and to improve the functionality and ease of use of EHRs.

“This draft strategy includes recommendations that will allow physicians and other clinicians to provide effective care to their patients with a renewed sense of satisfaction for them and their patients,” Andrew Gettinger, MD, chief clinical officer at ONC, and Kate Goodrich, MD, chief medical officer at the Centers for Medicare & Medicaid Services, wrote in a recent blog post. “We are taking one more step toward improving the interoperability and usability of health information by establishing a goal, strategy, and recommendations to reduce regulatory and administrative burdens relating to the use of EHRs.”

To ease documentation burdens, the proposal seeks to “mitigate the EHR-related burden associated with a variety of administrative processes,” the draft strategy notes. “We are considering how reforming certain administrative requirements or optimizing out-of-date requirements for health IT–enabled health care provider work flows can reduce the burden of clinical documentation.”

Specifically, ONC proposes to reduce the overall regulatory burden, leverage data present in the electronic record to reduce the redocumentation, waive certain documentation requirements for participants in advanced alternative payment models (APMs), and promote standardized documentation for ordering and prior authorization.

To improve health IT usability, the draft strategy aims to “address how improvements in the design and use of health IT systems” can reduce burden and calls on clinicians, software developers, and other vendors to collaborate.

To do so, ONC recommends better alignment between EHR design and clinical work flow and making improvements to clinical decision support, as well as improving the presentation of clinical data within EHRs and clinical documentation functionality.

ONC also recommends standardizing basic clinical operations across all EHRs, designing EHR interfaces that are standard to health care delivery, and better integration of the EHR with the exam room.

The draft strategy also includes recommendations to help doctors better understand the financial requirements for successful implementation and optimize the log-in procedures to help reduce burden.

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EHR reporting strategies “are designed to address many of the programmatic, technical, and operational challenges raised by stakeholders to reduce EHR-related burden associated with program reporting.”

ONC wants to simplify scoring for the “promoting interoperability” performance category in the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program and improving other measures of health IT usage; applying additional data standards to make data access, extraction, and integration across multiple systems easier and less costly; and exploring alternate, less burdensome approaches to electronic quality measurement through pilot programs and reporting program incentives.

Finally, public health reporting strategies “look at a set of topics linked to federal, state, local, territorial, and tribal government policies and public health programs, with a specific focus on EPCS [electronic prescribing for controlled substances] and PDMPs [prescription drug monitoring programs]. Where EHR-related burden remains a key barrier to progress in these areas, there are several recommendations for how stakeholders can advance these burden reduction goals related to public health.”

In this area, ONC is recommending increasing adoption of e-prescribing of controlled substances with access to medication history to better inform prescribing of controlled substances, harmonizing reporting requirements across federally funded programs to streamline reporting requirements, and providing better guidance about HIPPA and federal confidentially requirements governing substance abuse disorder to better facilitate the electronic exchange of health information for patient care.

Comments on the report may be submitted electronically through Jan. 28, 2019.

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A new federal proposal aims to move you away from the keyboard and back face-to-face with your patients.

Dr. Kate Goodrich

The draft strategy from the Office of the National Coordinator for Health IT has three aims: to reduce the time and effort to record information in EHRs; to reduce the time and effort required to meet regulatory requirements; and to improve the functionality and ease of use of EHRs.

“This draft strategy includes recommendations that will allow physicians and other clinicians to provide effective care to their patients with a renewed sense of satisfaction for them and their patients,” Andrew Gettinger, MD, chief clinical officer at ONC, and Kate Goodrich, MD, chief medical officer at the Centers for Medicare & Medicaid Services, wrote in a recent blog post. “We are taking one more step toward improving the interoperability and usability of health information by establishing a goal, strategy, and recommendations to reduce regulatory and administrative burdens relating to the use of EHRs.”

To ease documentation burdens, the proposal seeks to “mitigate the EHR-related burden associated with a variety of administrative processes,” the draft strategy notes. “We are considering how reforming certain administrative requirements or optimizing out-of-date requirements for health IT–enabled health care provider work flows can reduce the burden of clinical documentation.”

Specifically, ONC proposes to reduce the overall regulatory burden, leverage data present in the electronic record to reduce the redocumentation, waive certain documentation requirements for participants in advanced alternative payment models (APMs), and promote standardized documentation for ordering and prior authorization.

To improve health IT usability, the draft strategy aims to “address how improvements in the design and use of health IT systems” can reduce burden and calls on clinicians, software developers, and other vendors to collaborate.

To do so, ONC recommends better alignment between EHR design and clinical work flow and making improvements to clinical decision support, as well as improving the presentation of clinical data within EHRs and clinical documentation functionality.

ONC also recommends standardizing basic clinical operations across all EHRs, designing EHR interfaces that are standard to health care delivery, and better integration of the EHR with the exam room.

The draft strategy also includes recommendations to help doctors better understand the financial requirements for successful implementation and optimize the log-in procedures to help reduce burden.

thinkstockphotos.com

EHR reporting strategies “are designed to address many of the programmatic, technical, and operational challenges raised by stakeholders to reduce EHR-related burden associated with program reporting.”

ONC wants to simplify scoring for the “promoting interoperability” performance category in the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program and improving other measures of health IT usage; applying additional data standards to make data access, extraction, and integration across multiple systems easier and less costly; and exploring alternate, less burdensome approaches to electronic quality measurement through pilot programs and reporting program incentives.

Finally, public health reporting strategies “look at a set of topics linked to federal, state, local, territorial, and tribal government policies and public health programs, with a specific focus on EPCS [electronic prescribing for controlled substances] and PDMPs [prescription drug monitoring programs]. Where EHR-related burden remains a key barrier to progress in these areas, there are several recommendations for how stakeholders can advance these burden reduction goals related to public health.”

In this area, ONC is recommending increasing adoption of e-prescribing of controlled substances with access to medication history to better inform prescribing of controlled substances, harmonizing reporting requirements across federally funded programs to streamline reporting requirements, and providing better guidance about HIPPA and federal confidentially requirements governing substance abuse disorder to better facilitate the electronic exchange of health information for patient care.

Comments on the report may be submitted electronically through Jan. 28, 2019.

 

A new federal proposal aims to move you away from the keyboard and back face-to-face with your patients.

Dr. Kate Goodrich

The draft strategy from the Office of the National Coordinator for Health IT has three aims: to reduce the time and effort to record information in EHRs; to reduce the time and effort required to meet regulatory requirements; and to improve the functionality and ease of use of EHRs.

“This draft strategy includes recommendations that will allow physicians and other clinicians to provide effective care to their patients with a renewed sense of satisfaction for them and their patients,” Andrew Gettinger, MD, chief clinical officer at ONC, and Kate Goodrich, MD, chief medical officer at the Centers for Medicare & Medicaid Services, wrote in a recent blog post. “We are taking one more step toward improving the interoperability and usability of health information by establishing a goal, strategy, and recommendations to reduce regulatory and administrative burdens relating to the use of EHRs.”

To ease documentation burdens, the proposal seeks to “mitigate the EHR-related burden associated with a variety of administrative processes,” the draft strategy notes. “We are considering how reforming certain administrative requirements or optimizing out-of-date requirements for health IT–enabled health care provider work flows can reduce the burden of clinical documentation.”

Specifically, ONC proposes to reduce the overall regulatory burden, leverage data present in the electronic record to reduce the redocumentation, waive certain documentation requirements for participants in advanced alternative payment models (APMs), and promote standardized documentation for ordering and prior authorization.

To improve health IT usability, the draft strategy aims to “address how improvements in the design and use of health IT systems” can reduce burden and calls on clinicians, software developers, and other vendors to collaborate.

To do so, ONC recommends better alignment between EHR design and clinical work flow and making improvements to clinical decision support, as well as improving the presentation of clinical data within EHRs and clinical documentation functionality.

ONC also recommends standardizing basic clinical operations across all EHRs, designing EHR interfaces that are standard to health care delivery, and better integration of the EHR with the exam room.

The draft strategy also includes recommendations to help doctors better understand the financial requirements for successful implementation and optimize the log-in procedures to help reduce burden.

thinkstockphotos.com

EHR reporting strategies “are designed to address many of the programmatic, technical, and operational challenges raised by stakeholders to reduce EHR-related burden associated with program reporting.”

ONC wants to simplify scoring for the “promoting interoperability” performance category in the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program and improving other measures of health IT usage; applying additional data standards to make data access, extraction, and integration across multiple systems easier and less costly; and exploring alternate, less burdensome approaches to electronic quality measurement through pilot programs and reporting program incentives.

Finally, public health reporting strategies “look at a set of topics linked to federal, state, local, territorial, and tribal government policies and public health programs, with a specific focus on EPCS [electronic prescribing for controlled substances] and PDMPs [prescription drug monitoring programs]. Where EHR-related burden remains a key barrier to progress in these areas, there are several recommendations for how stakeholders can advance these burden reduction goals related to public health.”

In this area, ONC is recommending increasing adoption of e-prescribing of controlled substances with access to medication history to better inform prescribing of controlled substances, harmonizing reporting requirements across federally funded programs to streamline reporting requirements, and providing better guidance about HIPPA and federal confidentially requirements governing substance abuse disorder to better facilitate the electronic exchange of health information for patient care.

Comments on the report may be submitted electronically through Jan. 28, 2019.

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Giving hospitalists a larger clinical footprint

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Something you did not know about warm handoffs

I am going to teach you something you do not know. I am almost sure of it.

Dr. Bradley Flansbaum

Warm handoffs – a term you often hear within the confines of hospital walls when transferring a patient service to service or ward to ward. You do it in-house, but it’s unlikely you make the same connection when you discharge the same patient or transfer them to an outside entity.

But you have to be asleep under a rock not to have heard or read the changes afoot in the skilled nursing facility (SNF) realm, including the rise of the “SNFist. Too much variation in use and spending; plus, we are learning patients do not need 25 days cooped up in a rehabilitation facility when 15 might do with a segue into home health for another 10 or 14. Patients like being home, and it costs a lot less.

Unfortunately, we do not do SNF handoffs in the same manner as ICUs. Our bad, and inpatient providers better adapt.

As hospitals decant and quality measures get an intimate look in the rehab space, SNFs will notice sicker patients, and the staff there will be more mindful of the sign outs and the data they receive. Know a Centers for Medicare & Medicaid Services value-based program started on October 1 (just like hospitals – penalties and all) and SNFists, whoever they might be – NP/PA/DO/MD – will also require of hospitals a step-up in information transfer, both in quality and timeliness.

Read the full post at hospitalleader.org.

Also on The Hospital Leader

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Something you did not know about warm handoffs

Something you did not know about warm handoffs

I am going to teach you something you do not know. I am almost sure of it.

Dr. Bradley Flansbaum

Warm handoffs – a term you often hear within the confines of hospital walls when transferring a patient service to service or ward to ward. You do it in-house, but it’s unlikely you make the same connection when you discharge the same patient or transfer them to an outside entity.

But you have to be asleep under a rock not to have heard or read the changes afoot in the skilled nursing facility (SNF) realm, including the rise of the “SNFist. Too much variation in use and spending; plus, we are learning patients do not need 25 days cooped up in a rehabilitation facility when 15 might do with a segue into home health for another 10 or 14. Patients like being home, and it costs a lot less.

Unfortunately, we do not do SNF handoffs in the same manner as ICUs. Our bad, and inpatient providers better adapt.

As hospitals decant and quality measures get an intimate look in the rehab space, SNFs will notice sicker patients, and the staff there will be more mindful of the sign outs and the data they receive. Know a Centers for Medicare & Medicaid Services value-based program started on October 1 (just like hospitals – penalties and all) and SNFists, whoever they might be – NP/PA/DO/MD – will also require of hospitals a step-up in information transfer, both in quality and timeliness.

Read the full post at hospitalleader.org.

Also on The Hospital Leader

I am going to teach you something you do not know. I am almost sure of it.

Dr. Bradley Flansbaum

Warm handoffs – a term you often hear within the confines of hospital walls when transferring a patient service to service or ward to ward. You do it in-house, but it’s unlikely you make the same connection when you discharge the same patient or transfer them to an outside entity.

But you have to be asleep under a rock not to have heard or read the changes afoot in the skilled nursing facility (SNF) realm, including the rise of the “SNFist. Too much variation in use and spending; plus, we are learning patients do not need 25 days cooped up in a rehabilitation facility when 15 might do with a segue into home health for another 10 or 14. Patients like being home, and it costs a lot less.

Unfortunately, we do not do SNF handoffs in the same manner as ICUs. Our bad, and inpatient providers better adapt.

As hospitals decant and quality measures get an intimate look in the rehab space, SNFs will notice sicker patients, and the staff there will be more mindful of the sign outs and the data they receive. Know a Centers for Medicare & Medicaid Services value-based program started on October 1 (just like hospitals – penalties and all) and SNFists, whoever they might be – NP/PA/DO/MD – will also require of hospitals a step-up in information transfer, both in quality and timeliness.

Read the full post at hospitalleader.org.

Also on The Hospital Leader

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DOAC pause yields favorable outcomes for AF patients

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Wed, 06/07/2023 - 10:04

– In patients with atrial fibrillation who had direct oral anticoagulant (DOAC) interruption for an elective surgery, a simple and standardized management strategy yielded low rates of bleeding and thromboembolism, according to results of a prospective study of more than 3,000 patients.

Rates of major bleeding were less than 2% and rates of arterial thromboembolism were less than 1% in patients managed in accordance with the strategy, which foregoes heparin bridging and preoperative coagulation testing, according to investigator James D. Douketis, MD, of St. Joseph’s Healthcare and McMaster University, Hamilton, Ont.

“This is the first study to demonstrate the safety of a standardized perioperative management approach in a patients with atrial fibrillation who are taking a DOAC, and we hope will establish a standard and will have an effect on our clinical practice guidelines,” Dr. Douketis said during a press briefing at the annual meeting of the American Society of Hematology.

This trial offers the “most definitive evidence to date” that atrial fibrillation patients can – in an organized fashion based on bleeding risk – safely stop taking DOACs, said Mark Crowther, MD, chair and professor of medicine at McMaster University.

“This study will almost instantaneously establish a treatment practice and a treatment standard for the vast number of patients in North America and around the world who take these drugs,” added Dr. Crowther, who moderated the press briefing.


The PAUSE study included three parallel cohorts of atrial fibrillation patients taking DOACs (apixaban, dabigatran, or rivaroxaban) who required anticoagulant interruption for an elective surgery or procedure.

The DOAC interruptions were done using standardized protocols based on the pharmacokinetic properties of each DOAC, procedure-associated bleeding risk, and creatinine clearance, the investigators reported.

The interruptions occurred 1 day before and after low bleeding risk surgeries, and 2 days before and after high bleeding risk surgeries, while longer interruptions were used in patients receiving dabigatran who had a creatinine clearance below 50 mL/min.

A total of 3,007 patients at 23 sites in Canada, the United States, and Europe were managed by this approach in the PAUSE study – 1,257 patients receiving apixaban, 668 receiving dabigatran, and 1,082 receiving rivaroxaban – and were evaluated weekly for 30 days post-procedure.

PAUSE is the largest study to date that addresses how to manage the common problem of perioperative DOAC management. It is likely to have a practice-changing impact and will inform future practice guidelines in perioperative care.


The 30-day postoperative rate of major bleeding was low, according to investigators, at 1.35% (95% confidence interval, 0-2.00%) for apixaban, 0.90% (95% CI, 0-1.73%) for dabigatran, and 1.85% (95% CI, 0-2.65%) for rivaroxaban, Dr. Douketis reported.

Likewise, the rate of arterial thromboembolism was low at 0.16% (95% CI, 0-0.48%) for apixaban, 0.6% (95% CI, 0-1.33%) for dabigatran, and 0.37% (95% CI, 0-0.82%) for rivaroxaban, he said.

Most patients (greater than 90%) had minimal to no residual DOAC levels at the time of surgery, the investigator added.

The study was funded by the Canadian Institutes of Health Research and the H&S Foundation of Canada. Dr. Douketis reported disclosures related to Janssen, which makes rivaroxaban; Boehringer-Ingelheim, which makes dabigatran; and other companies. Dr. Crowther reported financial relationships with Bristol-Myers Squibb and other companies.

SOURCE: Douketis J et al. ASH 2018, Abstract LBA-5.

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– In patients with atrial fibrillation who had direct oral anticoagulant (DOAC) interruption for an elective surgery, a simple and standardized management strategy yielded low rates of bleeding and thromboembolism, according to results of a prospective study of more than 3,000 patients.

Rates of major bleeding were less than 2% and rates of arterial thromboembolism were less than 1% in patients managed in accordance with the strategy, which foregoes heparin bridging and preoperative coagulation testing, according to investigator James D. Douketis, MD, of St. Joseph’s Healthcare and McMaster University, Hamilton, Ont.

“This is the first study to demonstrate the safety of a standardized perioperative management approach in a patients with atrial fibrillation who are taking a DOAC, and we hope will establish a standard and will have an effect on our clinical practice guidelines,” Dr. Douketis said during a press briefing at the annual meeting of the American Society of Hematology.

This trial offers the “most definitive evidence to date” that atrial fibrillation patients can – in an organized fashion based on bleeding risk – safely stop taking DOACs, said Mark Crowther, MD, chair and professor of medicine at McMaster University.

“This study will almost instantaneously establish a treatment practice and a treatment standard for the vast number of patients in North America and around the world who take these drugs,” added Dr. Crowther, who moderated the press briefing.


The PAUSE study included three parallel cohorts of atrial fibrillation patients taking DOACs (apixaban, dabigatran, or rivaroxaban) who required anticoagulant interruption for an elective surgery or procedure.

The DOAC interruptions were done using standardized protocols based on the pharmacokinetic properties of each DOAC, procedure-associated bleeding risk, and creatinine clearance, the investigators reported.

The interruptions occurred 1 day before and after low bleeding risk surgeries, and 2 days before and after high bleeding risk surgeries, while longer interruptions were used in patients receiving dabigatran who had a creatinine clearance below 50 mL/min.

A total of 3,007 patients at 23 sites in Canada, the United States, and Europe were managed by this approach in the PAUSE study – 1,257 patients receiving apixaban, 668 receiving dabigatran, and 1,082 receiving rivaroxaban – and were evaluated weekly for 30 days post-procedure.

PAUSE is the largest study to date that addresses how to manage the common problem of perioperative DOAC management. It is likely to have a practice-changing impact and will inform future practice guidelines in perioperative care.


The 30-day postoperative rate of major bleeding was low, according to investigators, at 1.35% (95% confidence interval, 0-2.00%) for apixaban, 0.90% (95% CI, 0-1.73%) for dabigatran, and 1.85% (95% CI, 0-2.65%) for rivaroxaban, Dr. Douketis reported.

Likewise, the rate of arterial thromboembolism was low at 0.16% (95% CI, 0-0.48%) for apixaban, 0.6% (95% CI, 0-1.33%) for dabigatran, and 0.37% (95% CI, 0-0.82%) for rivaroxaban, he said.

Most patients (greater than 90%) had minimal to no residual DOAC levels at the time of surgery, the investigator added.

The study was funded by the Canadian Institutes of Health Research and the H&S Foundation of Canada. Dr. Douketis reported disclosures related to Janssen, which makes rivaroxaban; Boehringer-Ingelheim, which makes dabigatran; and other companies. Dr. Crowther reported financial relationships with Bristol-Myers Squibb and other companies.

SOURCE: Douketis J et al. ASH 2018, Abstract LBA-5.

– In patients with atrial fibrillation who had direct oral anticoagulant (DOAC) interruption for an elective surgery, a simple and standardized management strategy yielded low rates of bleeding and thromboembolism, according to results of a prospective study of more than 3,000 patients.

Rates of major bleeding were less than 2% and rates of arterial thromboembolism were less than 1% in patients managed in accordance with the strategy, which foregoes heparin bridging and preoperative coagulation testing, according to investigator James D. Douketis, MD, of St. Joseph’s Healthcare and McMaster University, Hamilton, Ont.

“This is the first study to demonstrate the safety of a standardized perioperative management approach in a patients with atrial fibrillation who are taking a DOAC, and we hope will establish a standard and will have an effect on our clinical practice guidelines,” Dr. Douketis said during a press briefing at the annual meeting of the American Society of Hematology.

This trial offers the “most definitive evidence to date” that atrial fibrillation patients can – in an organized fashion based on bleeding risk – safely stop taking DOACs, said Mark Crowther, MD, chair and professor of medicine at McMaster University.

“This study will almost instantaneously establish a treatment practice and a treatment standard for the vast number of patients in North America and around the world who take these drugs,” added Dr. Crowther, who moderated the press briefing.


The PAUSE study included three parallel cohorts of atrial fibrillation patients taking DOACs (apixaban, dabigatran, or rivaroxaban) who required anticoagulant interruption for an elective surgery or procedure.

The DOAC interruptions were done using standardized protocols based on the pharmacokinetic properties of each DOAC, procedure-associated bleeding risk, and creatinine clearance, the investigators reported.

The interruptions occurred 1 day before and after low bleeding risk surgeries, and 2 days before and after high bleeding risk surgeries, while longer interruptions were used in patients receiving dabigatran who had a creatinine clearance below 50 mL/min.

A total of 3,007 patients at 23 sites in Canada, the United States, and Europe were managed by this approach in the PAUSE study – 1,257 patients receiving apixaban, 668 receiving dabigatran, and 1,082 receiving rivaroxaban – and were evaluated weekly for 30 days post-procedure.

PAUSE is the largest study to date that addresses how to manage the common problem of perioperative DOAC management. It is likely to have a practice-changing impact and will inform future practice guidelines in perioperative care.


The 30-day postoperative rate of major bleeding was low, according to investigators, at 1.35% (95% confidence interval, 0-2.00%) for apixaban, 0.90% (95% CI, 0-1.73%) for dabigatran, and 1.85% (95% CI, 0-2.65%) for rivaroxaban, Dr. Douketis reported.

Likewise, the rate of arterial thromboembolism was low at 0.16% (95% CI, 0-0.48%) for apixaban, 0.6% (95% CI, 0-1.33%) for dabigatran, and 0.37% (95% CI, 0-0.82%) for rivaroxaban, he said.

Most patients (greater than 90%) had minimal to no residual DOAC levels at the time of surgery, the investigator added.

The study was funded by the Canadian Institutes of Health Research and the H&S Foundation of Canada. Dr. Douketis reported disclosures related to Janssen, which makes rivaroxaban; Boehringer-Ingelheim, which makes dabigatran; and other companies. Dr. Crowther reported financial relationships with Bristol-Myers Squibb and other companies.

SOURCE: Douketis J et al. ASH 2018, Abstract LBA-5.

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Key clinical point: A standardized management strategy for direct oral anticoagulant interruption before surgery yielded low rates of bleeding and thromboembolism in atrial fibrillation patients.

Major finding: The 30-day postoperative rate of major bleeding was 1.35% (95% CI, 0-2.00%) for apixaban, 0.90% (95% CI, 0-1.73%) for dabigatran, and 1.85% (95% CI, 0-2.65%) for rivaroxaban.

Study details: A prospective study of more than 3,000 subjects with atrial fibrillation who underwent DOAC interruption due to an elective surgery or procedure.

Disclosures: The study was funded by the Canadian Institutes of Health Research and H&S Foundation of Canada. Dr. Douketis reported disclosures related to Janssen, which makes rivaroxaban; Boehringer-Ingelheim, which makes dabigatran; and other companies.

Source: Douketis J et al. ASH 2018, Abstract LBA-5.

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EARLY: Angiography within 2 hours of acute non-ST event cut recurrent ischemic events

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Tue, 12/04/2018 - 12:07

CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.

Dr. Laurent Bonello

EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.

“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.

The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.

The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.

On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.

Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.

Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).

Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.

Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.

The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.

In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.

Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.

“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.

Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.

Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.

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CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.

Dr. Laurent Bonello

EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.

“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.

The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.

The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.

On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.

Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.

Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).

Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.

Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.

The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.

In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.

Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.

“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.

Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.

Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.

CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.

Dr. Laurent Bonello

EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.

“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.

The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.

The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.

On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.

Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.

Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).

Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.

Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.

The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.

In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.

Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.

“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.

Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.

Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.

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REPORTING FROM THE AHA SCIENTIFIC SESSIONS

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Key clinical point: Coronary angiography within 2 hours of non–ST-segment elevation acute coronary syndrome yielded improved outcomes.

Major finding: Rates of major cardiovascular events were 4.4% with early intervention and 21.3% with delayed intervention.

Study details: Prospective, multicenter, randomized clinical trial of 709 patients.

Disclosures: Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The trial received funding from the French Ministry of Health.

Source: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.

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Building on diversity

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Thu, 12/06/2018 - 11:31

Maryland SHM chapter follows expansive vision

 

Nidhi Goel, MD, MHS, is a Med-Peds hospitalist and assistant professor of internal medicine and pediatrics at the University of Maryland, Baltimore. Since August 2017, she has been the president of the Maryland chapter of SHM.

Dr. Nidhi Goel


The Hospitalist recently sat down with her to discuss some of the initiatives that the large and active Maryland chapter is focused on.
 

Can you talk about your background and how you became interested in hospital medicine?

I grew up in the Baltimore area, and I went to medical school at the University of Maryland in Baltimore. I trained in internal medicine and pediatrics, also at the University of Maryland. Then I joined the faculty after I finished residency in 2014. I practiced as a hospitalist in internal medicine and pediatrics and was also a teaching hospitalist.

Early in my residency, I worked with teaching hospitalists. I rotated on the hospitalist teams, and I was inspired by their perspective on taking care of patients through a lens of quality and safety. I gained a greater appreciation for the risks associated with taking care of a patient in the hospital setting, and the opportunities to mitigate those risks and provide really high quality patient care. It made me realize that was what I wanted to do – and also to teach residents and students how to do the same.
 

So it was a philosophical attraction to the hospitalist approach?

Yes, and intellectually I’d say that I liked taking care of really complicated, very sick patients. I found that to be interesting – and rewarding when they got better.

Tell us more about what kind of research you do.

I work primarily on projects centered on quality and safety; they involve both adult internal medicine and pediatric patients. Currently on the adult medicine side, we have a project looking at improving outcomes for sepsis in the hospital setting. On the pediatric side, I’ve done a lot of work related to throughput – trying to increase the efficiency of our admissions – and especially our discharge process. Moving patients through the system efficiently has become a significant quality issue, especially during the winter months when our volumes pick up.

How long have you been involved in the Maryland SHM chapter, and what are the rewards of participation?

Early in my residency, I got involved in the chapter because some of the hospitalist faculty I worked with were chapter officers. They believed that the chapter was a good place for residents to be exposed to research and to other hospitalists for networking and camaraderie. So they began inviting us to Maryland chapter meetings, and I found those meetings to be very enlightening – from the practical and research content related to hospital medicine, and to networking with other hospitalists.

I was invited to be part of the Maryland chapter advisory board when I was still a resident, so that I might present trainee perspectives on how the chapter could continue to grow and target some of their activities for the benefit of residents. I stayed involved with the chapter after I finished residency, and when the opportunity presented itself to become an officer, and I decided to take it. I thought serving as a chapter officer would be a really interesting chance to meet more people in the field and to continue to innovate within the chapter setting.
 

 

 

Tell us more about the Maryland chapter.

We are a large chapter and we’re very, very active. Around 7 or 8 years ago, the Maryland chapter reached a significant turning point because the officers that were in place at that time had a vision for building the chapter. That was a major inflexion point in how active the chapter became, leading to the kinds of activities that we do now, and the variety of memberships.

One thing that I’m super proud of our chapter for is that we’ve really tried to continue building on the diversity that is represented in our membership. We have members stretching geographically all through the Baltimore and the Washington corridor, as well as out to western Maryland and the Eastern shore. The Maryland chapter has been able to attract members from different organizations throughout the state and from a diversity of practice settings. We have active members who are not just physicians, but also a nurse practitioners, physician assistants, and clinical pharmacists. We have members from throughout the health care delivery process, which really enriches the discussion and the value of the chapter as a whole.
 

What kind of initiatives and programs is the chapter working on?

Every year we have an abstracts competition at our fall meeting. Whoever wins that competition is allowed to present at the national SHM conference, which is a great opportunity. We’re really pushing that competition to make it an even more robust experience.

One thing that we had heard from some of our members, and that we recognized as a need as well, was to make our career guidance a little bit more robust. To that end, we’re creating a separate job fair that is almost like an employment workshop – to help people to buff up their CVs, to talk about interviewing skills, contracts, salary negotiations, as well as exposing job candidates to various hospital groups from throughout the area. That’s something that we’re really excited about. It’s going to take a lot of work, but I think it could be a really high-yield event for our members.

We’re also encouraging our nonphysician members to take more active leadership roles in the chapter; several of our nonphysician members on our chapter advisory board, including pharmacists and physician assistants, and we are trying to make sure that we’re also liaising with some of the professional organizations that represent our nonphysician members. So, for example, the clinical pharmacist who’s on our advisory board also is president of the Maryland chapter of the Society for Hospital Pharmacists. She brings a lot of really great ideas and interesting perspectives, and she’s brought a lot of exposure of our SHM chapter to the clinical pharmacy community as well.
 

What about more long-term goals for your chapter? What’s on the horizon?

We’re targeting early-career hospitalists and helping them to develop their career goals in whatever fashion they see as appropriate.

So, as someone who’s in academics, obviously research and publications are very important for me, but they’re not necessarily as important for other hospitalists. I think our early-career hospitalists are increasingly looking to incorporate things into their practice aside from direct patient care. Our members have interests in various elements of hospital medicine, including patient safety and quality improvement initiatives, clinical informatics, advocacy (especially related to the myriad aspects of health care reform), and strategies surrounding billing and denials. I think having our chapter help our members to realize some of those opportunities and develop their skills in a way that’s personally meaningful to them, as well as good for their marketability as they build their careers, would be a really positive step.

The ultimate goal of the chapter is to service members, so whatever long-term goals we have right now could definitely be fluid as time goes on.
 

 

 

What are some concerns of the chapter?

One area of significant discussion among hospitalists in Maryland has been global budgets. Our system of reimbursement is unique in the nation. It’s a system that aims to emphasize high-value care: the idea is to prioritize quality over quantity.

This system requires that hospitals rethink how we provide care in the inpatient setting, and how we create a continuum of care to the post-acute setting. It poses a lot of challenges, but also a lot of opportunities. Hospitalists are positioned perfectly to play a substantial role in implementing solutions.
 

Why might readers want to consider getting involved in their local SHM chapters?

I think it’s really beneficial to have the exposure that being involved with an SHM chapter brings – to people, to perspectives, to knowledge. There’s not really a downside to being involved with a chapter. You can take as little or as much as you want out of it, but I think most of our members find it to be a very enriching experience. Being involved in a chapter means you can have a voice, so that the chapter ends up serving you and your needs as well.

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Maryland SHM chapter follows expansive vision

Maryland SHM chapter follows expansive vision

 

Nidhi Goel, MD, MHS, is a Med-Peds hospitalist and assistant professor of internal medicine and pediatrics at the University of Maryland, Baltimore. Since August 2017, she has been the president of the Maryland chapter of SHM.

Dr. Nidhi Goel


The Hospitalist recently sat down with her to discuss some of the initiatives that the large and active Maryland chapter is focused on.
 

Can you talk about your background and how you became interested in hospital medicine?

I grew up in the Baltimore area, and I went to medical school at the University of Maryland in Baltimore. I trained in internal medicine and pediatrics, also at the University of Maryland. Then I joined the faculty after I finished residency in 2014. I practiced as a hospitalist in internal medicine and pediatrics and was also a teaching hospitalist.

Early in my residency, I worked with teaching hospitalists. I rotated on the hospitalist teams, and I was inspired by their perspective on taking care of patients through a lens of quality and safety. I gained a greater appreciation for the risks associated with taking care of a patient in the hospital setting, and the opportunities to mitigate those risks and provide really high quality patient care. It made me realize that was what I wanted to do – and also to teach residents and students how to do the same.
 

So it was a philosophical attraction to the hospitalist approach?

Yes, and intellectually I’d say that I liked taking care of really complicated, very sick patients. I found that to be interesting – and rewarding when they got better.

Tell us more about what kind of research you do.

I work primarily on projects centered on quality and safety; they involve both adult internal medicine and pediatric patients. Currently on the adult medicine side, we have a project looking at improving outcomes for sepsis in the hospital setting. On the pediatric side, I’ve done a lot of work related to throughput – trying to increase the efficiency of our admissions – and especially our discharge process. Moving patients through the system efficiently has become a significant quality issue, especially during the winter months when our volumes pick up.

How long have you been involved in the Maryland SHM chapter, and what are the rewards of participation?

Early in my residency, I got involved in the chapter because some of the hospitalist faculty I worked with were chapter officers. They believed that the chapter was a good place for residents to be exposed to research and to other hospitalists for networking and camaraderie. So they began inviting us to Maryland chapter meetings, and I found those meetings to be very enlightening – from the practical and research content related to hospital medicine, and to networking with other hospitalists.

I was invited to be part of the Maryland chapter advisory board when I was still a resident, so that I might present trainee perspectives on how the chapter could continue to grow and target some of their activities for the benefit of residents. I stayed involved with the chapter after I finished residency, and when the opportunity presented itself to become an officer, and I decided to take it. I thought serving as a chapter officer would be a really interesting chance to meet more people in the field and to continue to innovate within the chapter setting.
 

 

 

Tell us more about the Maryland chapter.

We are a large chapter and we’re very, very active. Around 7 or 8 years ago, the Maryland chapter reached a significant turning point because the officers that were in place at that time had a vision for building the chapter. That was a major inflexion point in how active the chapter became, leading to the kinds of activities that we do now, and the variety of memberships.

One thing that I’m super proud of our chapter for is that we’ve really tried to continue building on the diversity that is represented in our membership. We have members stretching geographically all through the Baltimore and the Washington corridor, as well as out to western Maryland and the Eastern shore. The Maryland chapter has been able to attract members from different organizations throughout the state and from a diversity of practice settings. We have active members who are not just physicians, but also a nurse practitioners, physician assistants, and clinical pharmacists. We have members from throughout the health care delivery process, which really enriches the discussion and the value of the chapter as a whole.
 

What kind of initiatives and programs is the chapter working on?

Every year we have an abstracts competition at our fall meeting. Whoever wins that competition is allowed to present at the national SHM conference, which is a great opportunity. We’re really pushing that competition to make it an even more robust experience.

One thing that we had heard from some of our members, and that we recognized as a need as well, was to make our career guidance a little bit more robust. To that end, we’re creating a separate job fair that is almost like an employment workshop – to help people to buff up their CVs, to talk about interviewing skills, contracts, salary negotiations, as well as exposing job candidates to various hospital groups from throughout the area. That’s something that we’re really excited about. It’s going to take a lot of work, but I think it could be a really high-yield event for our members.

We’re also encouraging our nonphysician members to take more active leadership roles in the chapter; several of our nonphysician members on our chapter advisory board, including pharmacists and physician assistants, and we are trying to make sure that we’re also liaising with some of the professional organizations that represent our nonphysician members. So, for example, the clinical pharmacist who’s on our advisory board also is president of the Maryland chapter of the Society for Hospital Pharmacists. She brings a lot of really great ideas and interesting perspectives, and she’s brought a lot of exposure of our SHM chapter to the clinical pharmacy community as well.
 

What about more long-term goals for your chapter? What’s on the horizon?

We’re targeting early-career hospitalists and helping them to develop their career goals in whatever fashion they see as appropriate.

So, as someone who’s in academics, obviously research and publications are very important for me, but they’re not necessarily as important for other hospitalists. I think our early-career hospitalists are increasingly looking to incorporate things into their practice aside from direct patient care. Our members have interests in various elements of hospital medicine, including patient safety and quality improvement initiatives, clinical informatics, advocacy (especially related to the myriad aspects of health care reform), and strategies surrounding billing and denials. I think having our chapter help our members to realize some of those opportunities and develop their skills in a way that’s personally meaningful to them, as well as good for their marketability as they build their careers, would be a really positive step.

The ultimate goal of the chapter is to service members, so whatever long-term goals we have right now could definitely be fluid as time goes on.
 

 

 

What are some concerns of the chapter?

One area of significant discussion among hospitalists in Maryland has been global budgets. Our system of reimbursement is unique in the nation. It’s a system that aims to emphasize high-value care: the idea is to prioritize quality over quantity.

This system requires that hospitals rethink how we provide care in the inpatient setting, and how we create a continuum of care to the post-acute setting. It poses a lot of challenges, but also a lot of opportunities. Hospitalists are positioned perfectly to play a substantial role in implementing solutions.
 

Why might readers want to consider getting involved in their local SHM chapters?

I think it’s really beneficial to have the exposure that being involved with an SHM chapter brings – to people, to perspectives, to knowledge. There’s not really a downside to being involved with a chapter. You can take as little or as much as you want out of it, but I think most of our members find it to be a very enriching experience. Being involved in a chapter means you can have a voice, so that the chapter ends up serving you and your needs as well.

 

Nidhi Goel, MD, MHS, is a Med-Peds hospitalist and assistant professor of internal medicine and pediatrics at the University of Maryland, Baltimore. Since August 2017, she has been the president of the Maryland chapter of SHM.

Dr. Nidhi Goel


The Hospitalist recently sat down with her to discuss some of the initiatives that the large and active Maryland chapter is focused on.
 

Can you talk about your background and how you became interested in hospital medicine?

I grew up in the Baltimore area, and I went to medical school at the University of Maryland in Baltimore. I trained in internal medicine and pediatrics, also at the University of Maryland. Then I joined the faculty after I finished residency in 2014. I practiced as a hospitalist in internal medicine and pediatrics and was also a teaching hospitalist.

Early in my residency, I worked with teaching hospitalists. I rotated on the hospitalist teams, and I was inspired by their perspective on taking care of patients through a lens of quality and safety. I gained a greater appreciation for the risks associated with taking care of a patient in the hospital setting, and the opportunities to mitigate those risks and provide really high quality patient care. It made me realize that was what I wanted to do – and also to teach residents and students how to do the same.
 

So it was a philosophical attraction to the hospitalist approach?

Yes, and intellectually I’d say that I liked taking care of really complicated, very sick patients. I found that to be interesting – and rewarding when they got better.

Tell us more about what kind of research you do.

I work primarily on projects centered on quality and safety; they involve both adult internal medicine and pediatric patients. Currently on the adult medicine side, we have a project looking at improving outcomes for sepsis in the hospital setting. On the pediatric side, I’ve done a lot of work related to throughput – trying to increase the efficiency of our admissions – and especially our discharge process. Moving patients through the system efficiently has become a significant quality issue, especially during the winter months when our volumes pick up.

How long have you been involved in the Maryland SHM chapter, and what are the rewards of participation?

Early in my residency, I got involved in the chapter because some of the hospitalist faculty I worked with were chapter officers. They believed that the chapter was a good place for residents to be exposed to research and to other hospitalists for networking and camaraderie. So they began inviting us to Maryland chapter meetings, and I found those meetings to be very enlightening – from the practical and research content related to hospital medicine, and to networking with other hospitalists.

I was invited to be part of the Maryland chapter advisory board when I was still a resident, so that I might present trainee perspectives on how the chapter could continue to grow and target some of their activities for the benefit of residents. I stayed involved with the chapter after I finished residency, and when the opportunity presented itself to become an officer, and I decided to take it. I thought serving as a chapter officer would be a really interesting chance to meet more people in the field and to continue to innovate within the chapter setting.
 

 

 

Tell us more about the Maryland chapter.

We are a large chapter and we’re very, very active. Around 7 or 8 years ago, the Maryland chapter reached a significant turning point because the officers that were in place at that time had a vision for building the chapter. That was a major inflexion point in how active the chapter became, leading to the kinds of activities that we do now, and the variety of memberships.

One thing that I’m super proud of our chapter for is that we’ve really tried to continue building on the diversity that is represented in our membership. We have members stretching geographically all through the Baltimore and the Washington corridor, as well as out to western Maryland and the Eastern shore. The Maryland chapter has been able to attract members from different organizations throughout the state and from a diversity of practice settings. We have active members who are not just physicians, but also a nurse practitioners, physician assistants, and clinical pharmacists. We have members from throughout the health care delivery process, which really enriches the discussion and the value of the chapter as a whole.
 

What kind of initiatives and programs is the chapter working on?

Every year we have an abstracts competition at our fall meeting. Whoever wins that competition is allowed to present at the national SHM conference, which is a great opportunity. We’re really pushing that competition to make it an even more robust experience.

One thing that we had heard from some of our members, and that we recognized as a need as well, was to make our career guidance a little bit more robust. To that end, we’re creating a separate job fair that is almost like an employment workshop – to help people to buff up their CVs, to talk about interviewing skills, contracts, salary negotiations, as well as exposing job candidates to various hospital groups from throughout the area. That’s something that we’re really excited about. It’s going to take a lot of work, but I think it could be a really high-yield event for our members.

We’re also encouraging our nonphysician members to take more active leadership roles in the chapter; several of our nonphysician members on our chapter advisory board, including pharmacists and physician assistants, and we are trying to make sure that we’re also liaising with some of the professional organizations that represent our nonphysician members. So, for example, the clinical pharmacist who’s on our advisory board also is president of the Maryland chapter of the Society for Hospital Pharmacists. She brings a lot of really great ideas and interesting perspectives, and she’s brought a lot of exposure of our SHM chapter to the clinical pharmacy community as well.
 

What about more long-term goals for your chapter? What’s on the horizon?

We’re targeting early-career hospitalists and helping them to develop their career goals in whatever fashion they see as appropriate.

So, as someone who’s in academics, obviously research and publications are very important for me, but they’re not necessarily as important for other hospitalists. I think our early-career hospitalists are increasingly looking to incorporate things into their practice aside from direct patient care. Our members have interests in various elements of hospital medicine, including patient safety and quality improvement initiatives, clinical informatics, advocacy (especially related to the myriad aspects of health care reform), and strategies surrounding billing and denials. I think having our chapter help our members to realize some of those opportunities and develop their skills in a way that’s personally meaningful to them, as well as good for their marketability as they build their careers, would be a really positive step.

The ultimate goal of the chapter is to service members, so whatever long-term goals we have right now could definitely be fluid as time goes on.
 

 

 

What are some concerns of the chapter?

One area of significant discussion among hospitalists in Maryland has been global budgets. Our system of reimbursement is unique in the nation. It’s a system that aims to emphasize high-value care: the idea is to prioritize quality over quantity.

This system requires that hospitals rethink how we provide care in the inpatient setting, and how we create a continuum of care to the post-acute setting. It poses a lot of challenges, but also a lot of opportunities. Hospitalists are positioned perfectly to play a substantial role in implementing solutions.
 

Why might readers want to consider getting involved in their local SHM chapters?

I think it’s really beneficial to have the exposure that being involved with an SHM chapter brings – to people, to perspectives, to knowledge. There’s not really a downside to being involved with a chapter. You can take as little or as much as you want out of it, but I think most of our members find it to be a very enriching experience. Being involved in a chapter means you can have a voice, so that the chapter ends up serving you and your needs as well.

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ARISTOPHANES: Apixaban edges other DOACS for octogenarians

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– Apixaban outperformed two other direct-acting oral anticoagulants, dabigatran and rivaroxaban, by preventing more thrombotic events and not causing as many major bleeds in patients with atrial fibrillation who were at least 80 years old.

The findings come from an analysis of insurance claims data from more than 50,000 U.S. patients – the largest observational study to date to compare these three direct-acting oral anticoagulants (DOACs) in octogenarians with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, said at the American Heart Association scientific sessions.

“The results may help clinicians evaluate the risk-benefit ratio of the DOACs” in this population, said Dr. Deitelzweig, vice president for medical affairs at Ochsner Medical Center in New Orleans.

He noted that the results were consistent with prior reports from observational data and registries, as well as the results in a recent analysis commissioned by the Agency for Healthcare Research and Quality. “We see a consistent message that apixaban always has less risk for major bleeding, and at least comparable efficacy” when compared with other DOACs, he said in a video interview.

And for the foreseeable future, this sort of data will need to suffice for clinicians trying to decide which DOAC to use because “I know of no head-to-head trials, nor do I anticipate any head-to-head trials” that could provide a more definitive comparison of the DOACs, Dr. Deitelzweig said.

The data came from a large number of patients – about 38% of the U.S. population – which boosts the generalizability of the finding. “I think our data are useful” for helping to make treatment decisions, he concluded.

The analysis he reported came from the ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) study, which pooled U.S. insurance claims data from several sources. For the octogenarian study, Dr. Deitelzweig and his associates used data from about 123 million U.S. residents collected between January 2012 and September 2015 by Medicare and three different commercial insurance databases. The overall level of beneficiary overlap between these four data sources was less than 0.5%.

The researchers identified patients with nonvalvular atrial fibrillation who started anticoagulant treatment with a DOAC and were at least 80 years old. This included 19,752 patients started on apixaban (Eliquis), 6,741 started on dabigatran (Pradaxa), and 27,217 started on rivaroxaban (Xarelto). A majority of the patients were at least 84 years old.

The analysis used propensity-score matching to compare similar patients and to minimize the impact of potentially confounding differences among the patients in each treatment subgroup. During a median follow-up of 7-9 months, the incidence of stroke or systemic embolism was 35% lower in the apixaban-treated patients, compared with those who received dabigatran, and 28% lower in the apixaban patients, compared with those treated with rivaroxaban, both statistically significant differences, Dr. Deitelzweig reported. The incidence of major bleeding episodes was 40% lower with apixaban than with dabigatran and 50% lower with apixaban, compared with rivaroxaban, also statistically significant differences.

When the analysis compared dabigatran with rivaroxaban it showed no statistically significant difference for the efficacy endpoint, but dabigatran produced 23% fewer major bleeds than rivaroxaban, a statistically significant difference.

These findings jibed with a recently published analysis from Dr. Deitelzweig and his associates that used data from all adults with nonvalvular atrial fibrillation started on an oral anticoagulant in an expanded ARISTOPHANES database for 2012-2015 that included more than 180 million U.S. beneficiaries. After propensity-score matching, this created subgroups of about 58,000 patients started on apixaban, nearly 27,000 started on dabigatran, and more than 83,000 started on rivaroxaban. The patients averaged about 73 years old. Again, with about 7-9 months of follow-up, very similar outcomes occurred. Patients on apixaban had significantly fewer strokes and systemic embolic events as well as significantly fewer major bleeds compared with patients treated with one of the other DOACs (Stroke. 2018 Dec;49[12]:2933-44).

[email protected]

SOURCE: Deitelzweig SB et al. Circulation. 2018 Nov 6;138(suppl 1):A14900.

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– Apixaban outperformed two other direct-acting oral anticoagulants, dabigatran and rivaroxaban, by preventing more thrombotic events and not causing as many major bleeds in patients with atrial fibrillation who were at least 80 years old.

The findings come from an analysis of insurance claims data from more than 50,000 U.S. patients – the largest observational study to date to compare these three direct-acting oral anticoagulants (DOACs) in octogenarians with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, said at the American Heart Association scientific sessions.

“The results may help clinicians evaluate the risk-benefit ratio of the DOACs” in this population, said Dr. Deitelzweig, vice president for medical affairs at Ochsner Medical Center in New Orleans.

He noted that the results were consistent with prior reports from observational data and registries, as well as the results in a recent analysis commissioned by the Agency for Healthcare Research and Quality. “We see a consistent message that apixaban always has less risk for major bleeding, and at least comparable efficacy” when compared with other DOACs, he said in a video interview.

And for the foreseeable future, this sort of data will need to suffice for clinicians trying to decide which DOAC to use because “I know of no head-to-head trials, nor do I anticipate any head-to-head trials” that could provide a more definitive comparison of the DOACs, Dr. Deitelzweig said.

The data came from a large number of patients – about 38% of the U.S. population – which boosts the generalizability of the finding. “I think our data are useful” for helping to make treatment decisions, he concluded.

The analysis he reported came from the ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) study, which pooled U.S. insurance claims data from several sources. For the octogenarian study, Dr. Deitelzweig and his associates used data from about 123 million U.S. residents collected between January 2012 and September 2015 by Medicare and three different commercial insurance databases. The overall level of beneficiary overlap between these four data sources was less than 0.5%.

The researchers identified patients with nonvalvular atrial fibrillation who started anticoagulant treatment with a DOAC and were at least 80 years old. This included 19,752 patients started on apixaban (Eliquis), 6,741 started on dabigatran (Pradaxa), and 27,217 started on rivaroxaban (Xarelto). A majority of the patients were at least 84 years old.

The analysis used propensity-score matching to compare similar patients and to minimize the impact of potentially confounding differences among the patients in each treatment subgroup. During a median follow-up of 7-9 months, the incidence of stroke or systemic embolism was 35% lower in the apixaban-treated patients, compared with those who received dabigatran, and 28% lower in the apixaban patients, compared with those treated with rivaroxaban, both statistically significant differences, Dr. Deitelzweig reported. The incidence of major bleeding episodes was 40% lower with apixaban than with dabigatran and 50% lower with apixaban, compared with rivaroxaban, also statistically significant differences.

When the analysis compared dabigatran with rivaroxaban it showed no statistically significant difference for the efficacy endpoint, but dabigatran produced 23% fewer major bleeds than rivaroxaban, a statistically significant difference.

These findings jibed with a recently published analysis from Dr. Deitelzweig and his associates that used data from all adults with nonvalvular atrial fibrillation started on an oral anticoagulant in an expanded ARISTOPHANES database for 2012-2015 that included more than 180 million U.S. beneficiaries. After propensity-score matching, this created subgroups of about 58,000 patients started on apixaban, nearly 27,000 started on dabigatran, and more than 83,000 started on rivaroxaban. The patients averaged about 73 years old. Again, with about 7-9 months of follow-up, very similar outcomes occurred. Patients on apixaban had significantly fewer strokes and systemic embolic events as well as significantly fewer major bleeds compared with patients treated with one of the other DOACs (Stroke. 2018 Dec;49[12]:2933-44).

[email protected]

SOURCE: Deitelzweig SB et al. Circulation. 2018 Nov 6;138(suppl 1):A14900.

– Apixaban outperformed two other direct-acting oral anticoagulants, dabigatran and rivaroxaban, by preventing more thrombotic events and not causing as many major bleeds in patients with atrial fibrillation who were at least 80 years old.

The findings come from an analysis of insurance claims data from more than 50,000 U.S. patients – the largest observational study to date to compare these three direct-acting oral anticoagulants (DOACs) in octogenarians with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, said at the American Heart Association scientific sessions.

“The results may help clinicians evaluate the risk-benefit ratio of the DOACs” in this population, said Dr. Deitelzweig, vice president for medical affairs at Ochsner Medical Center in New Orleans.

He noted that the results were consistent with prior reports from observational data and registries, as well as the results in a recent analysis commissioned by the Agency for Healthcare Research and Quality. “We see a consistent message that apixaban always has less risk for major bleeding, and at least comparable efficacy” when compared with other DOACs, he said in a video interview.

And for the foreseeable future, this sort of data will need to suffice for clinicians trying to decide which DOAC to use because “I know of no head-to-head trials, nor do I anticipate any head-to-head trials” that could provide a more definitive comparison of the DOACs, Dr. Deitelzweig said.

The data came from a large number of patients – about 38% of the U.S. population – which boosts the generalizability of the finding. “I think our data are useful” for helping to make treatment decisions, he concluded.

The analysis he reported came from the ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) study, which pooled U.S. insurance claims data from several sources. For the octogenarian study, Dr. Deitelzweig and his associates used data from about 123 million U.S. residents collected between January 2012 and September 2015 by Medicare and three different commercial insurance databases. The overall level of beneficiary overlap between these four data sources was less than 0.5%.

The researchers identified patients with nonvalvular atrial fibrillation who started anticoagulant treatment with a DOAC and were at least 80 years old. This included 19,752 patients started on apixaban (Eliquis), 6,741 started on dabigatran (Pradaxa), and 27,217 started on rivaroxaban (Xarelto). A majority of the patients were at least 84 years old.

The analysis used propensity-score matching to compare similar patients and to minimize the impact of potentially confounding differences among the patients in each treatment subgroup. During a median follow-up of 7-9 months, the incidence of stroke or systemic embolism was 35% lower in the apixaban-treated patients, compared with those who received dabigatran, and 28% lower in the apixaban patients, compared with those treated with rivaroxaban, both statistically significant differences, Dr. Deitelzweig reported. The incidence of major bleeding episodes was 40% lower with apixaban than with dabigatran and 50% lower with apixaban, compared with rivaroxaban, also statistically significant differences.

When the analysis compared dabigatran with rivaroxaban it showed no statistically significant difference for the efficacy endpoint, but dabigatran produced 23% fewer major bleeds than rivaroxaban, a statistically significant difference.

These findings jibed with a recently published analysis from Dr. Deitelzweig and his associates that used data from all adults with nonvalvular atrial fibrillation started on an oral anticoagulant in an expanded ARISTOPHANES database for 2012-2015 that included more than 180 million U.S. beneficiaries. After propensity-score matching, this created subgroups of about 58,000 patients started on apixaban, nearly 27,000 started on dabigatran, and more than 83,000 started on rivaroxaban. The patients averaged about 73 years old. Again, with about 7-9 months of follow-up, very similar outcomes occurred. Patients on apixaban had significantly fewer strokes and systemic embolic events as well as significantly fewer major bleeds compared with patients treated with one of the other DOACs (Stroke. 2018 Dec;49[12]:2933-44).

[email protected]

SOURCE: Deitelzweig SB et al. Circulation. 2018 Nov 6;138(suppl 1):A14900.

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Key clinical point: Apixaban surpassed two other direct-acting oral anticoagulants in a large, observational database.

Major finding: The adjusted stroke or systemic embolism rate with apixaban was 35% less than dabigatran and 28% less than rivaroxaban.

Study details: A retrospective analysis of observational data collected in insurance claims from 53,710 U.S. octogenarians.

Disclosures: The study was funded by Bristol-Myers Squibb and Pfizer, the companies that market apixaban (Eliquis). Dr. Deitelzweig is a consultant to and speaker on behalf of Bristol-Myers Squibb and Pfizer. He is also a consultant to or speaker on behalf of Boehringer Ingelheim, Daiichi-Sankyo, Janssen, and Portola Pharmaceuticals.

Source: Deitelzweig SB et al. Circulation. 2018 Nov 6;138[suppl 1]:A14900.

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Hospitalist movers and shakers – Nov. 2018

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Fri, 11/30/2018 - 12:10

 

George Kasarala, MD, recently was named the hospitalist medical director at Nash UNC Health Care in Rocky Mount, N.C. Dr. Kasarala will guide Nash UNC’s team of hospitalists, a program that has partnered with Sound Physicians.

Dr. Kasarala has a wealth of hospitalist experience, serving in a variety of positions since 2012. He comes to Nash UNC from Vidant Medical Center in Greenville, N.C. Prior to that, he was the associate hospitalist program director at the Apogee Hospitalist program in Elkhart, Ind.

In addition to his medical degree from Saint Louis University, Dr. Kasarala holds a master of business administration from the University of Findlay (Ohio).

Dr. Donald W. Woodburn

Donald W. Woodburn, MD, has been selected as the new medical director at Carolinas Primary Care in Wadesboro, S.C. The longtime internist and hospitalist will stay in his role directing primary care for the facility, which is operated by Atrium Health.

A 35-year veteran in the medical field, Dr. Woodburn most recently was medical director for AnMed Hospitalist Services in Anderson, S.C. He has been a medical director in New York, Florida, and South Carolina since earning his medical degree from Howard University in Washington.
 

Rita Goyal, MD, has been hired as chief medical officer of ConcertCare, a health care technology company based in Birmingham, Ala. Dr. Goyal has expertise in both medicine and business was cited as the key to her appointment. She founded a Web-based medical consultation business in 2017, virtualMDvisit.net.

Dr. Goyal is an academic hospitalist at the University of Alabama, Birmingham, and will continue to serve as a hospitalist and in the University’s urgent care system.



Nirupma Sharma, MD, has been named chief of the newly minted division of pediatric hospital medicine at Augusta (Ga.) University Health. Dr. Sharma will oversee the pediatric hospitalist staff, including education, research, and clinical assistance.

Dr. Sharma has been the medical director of the 4C unit at Children’s Hospital of Georgia in Augusta. She also has served as associate director of the Medical College of Georgia’s department of pediatrics clerkship program.

Dr. Vineet Arora

Vineet Arora, MD, MHM, was recently named one of the top 10 doctors to follow on Twitter by Becker’s Hospital Review. Dr. Arora is an academic hospitalist at University of Chicago Medicine.

Using the hashtag #meded, Dr. Arora provides a wealth of medical knowledge on Twitter, currently boasting more than 29,000 followers on that social media platform. She also serves as the Journal of Hospital Medicine’s deputy social media editor, and blogs about topics trending in resident education.
 

BUSINESS MOVES

Aspirus Iron River (Mich.) Hospital has partnered with iNDIGO Health Partners to create a telehealth hospitalist program at night. iNDIGO, a private hospitalist group, will utilize two-way video to treat Aspirus patients during overnight hours.

The telehealth providers with iNDIGO are part of the staff at Aspirus Iron River and are familiar with the facility’s procedures. The remote physicians will be in contact with staff at the hospital, providing direction after meeting with patients via the video system.

The Hospitals of Providence Memorial Campus in El Paso, Tex., intends to have specialists on site at all times for expectant mothers after recently adopting an obstetric hospitalist program. The OB hospitalists will be available to treat patient concerns and medical emergencies that occur outside of normal hours for patients’ primary obstetricians.

All OB hospitalists will be board-certified OB physicians. The goal is to decrease wait times for expectant mothers, who can receive immediate assessments and treatment upon arrival in the emergency department.






 

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George Kasarala, MD, recently was named the hospitalist medical director at Nash UNC Health Care in Rocky Mount, N.C. Dr. Kasarala will guide Nash UNC’s team of hospitalists, a program that has partnered with Sound Physicians.

Dr. Kasarala has a wealth of hospitalist experience, serving in a variety of positions since 2012. He comes to Nash UNC from Vidant Medical Center in Greenville, N.C. Prior to that, he was the associate hospitalist program director at the Apogee Hospitalist program in Elkhart, Ind.

In addition to his medical degree from Saint Louis University, Dr. Kasarala holds a master of business administration from the University of Findlay (Ohio).

Dr. Donald W. Woodburn

Donald W. Woodburn, MD, has been selected as the new medical director at Carolinas Primary Care in Wadesboro, S.C. The longtime internist and hospitalist will stay in his role directing primary care for the facility, which is operated by Atrium Health.

A 35-year veteran in the medical field, Dr. Woodburn most recently was medical director for AnMed Hospitalist Services in Anderson, S.C. He has been a medical director in New York, Florida, and South Carolina since earning his medical degree from Howard University in Washington.
 

Rita Goyal, MD, has been hired as chief medical officer of ConcertCare, a health care technology company based in Birmingham, Ala. Dr. Goyal has expertise in both medicine and business was cited as the key to her appointment. She founded a Web-based medical consultation business in 2017, virtualMDvisit.net.

Dr. Goyal is an academic hospitalist at the University of Alabama, Birmingham, and will continue to serve as a hospitalist and in the University’s urgent care system.



Nirupma Sharma, MD, has been named chief of the newly minted division of pediatric hospital medicine at Augusta (Ga.) University Health. Dr. Sharma will oversee the pediatric hospitalist staff, including education, research, and clinical assistance.

Dr. Sharma has been the medical director of the 4C unit at Children’s Hospital of Georgia in Augusta. She also has served as associate director of the Medical College of Georgia’s department of pediatrics clerkship program.

Dr. Vineet Arora

Vineet Arora, MD, MHM, was recently named one of the top 10 doctors to follow on Twitter by Becker’s Hospital Review. Dr. Arora is an academic hospitalist at University of Chicago Medicine.

Using the hashtag #meded, Dr. Arora provides a wealth of medical knowledge on Twitter, currently boasting more than 29,000 followers on that social media platform. She also serves as the Journal of Hospital Medicine’s deputy social media editor, and blogs about topics trending in resident education.
 

BUSINESS MOVES

Aspirus Iron River (Mich.) Hospital has partnered with iNDIGO Health Partners to create a telehealth hospitalist program at night. iNDIGO, a private hospitalist group, will utilize two-way video to treat Aspirus patients during overnight hours.

The telehealth providers with iNDIGO are part of the staff at Aspirus Iron River and are familiar with the facility’s procedures. The remote physicians will be in contact with staff at the hospital, providing direction after meeting with patients via the video system.

The Hospitals of Providence Memorial Campus in El Paso, Tex., intends to have specialists on site at all times for expectant mothers after recently adopting an obstetric hospitalist program. The OB hospitalists will be available to treat patient concerns and medical emergencies that occur outside of normal hours for patients’ primary obstetricians.

All OB hospitalists will be board-certified OB physicians. The goal is to decrease wait times for expectant mothers, who can receive immediate assessments and treatment upon arrival in the emergency department.






 

 

George Kasarala, MD, recently was named the hospitalist medical director at Nash UNC Health Care in Rocky Mount, N.C. Dr. Kasarala will guide Nash UNC’s team of hospitalists, a program that has partnered with Sound Physicians.

Dr. Kasarala has a wealth of hospitalist experience, serving in a variety of positions since 2012. He comes to Nash UNC from Vidant Medical Center in Greenville, N.C. Prior to that, he was the associate hospitalist program director at the Apogee Hospitalist program in Elkhart, Ind.

In addition to his medical degree from Saint Louis University, Dr. Kasarala holds a master of business administration from the University of Findlay (Ohio).

Dr. Donald W. Woodburn

Donald W. Woodburn, MD, has been selected as the new medical director at Carolinas Primary Care in Wadesboro, S.C. The longtime internist and hospitalist will stay in his role directing primary care for the facility, which is operated by Atrium Health.

A 35-year veteran in the medical field, Dr. Woodburn most recently was medical director for AnMed Hospitalist Services in Anderson, S.C. He has been a medical director in New York, Florida, and South Carolina since earning his medical degree from Howard University in Washington.
 

Rita Goyal, MD, has been hired as chief medical officer of ConcertCare, a health care technology company based in Birmingham, Ala. Dr. Goyal has expertise in both medicine and business was cited as the key to her appointment. She founded a Web-based medical consultation business in 2017, virtualMDvisit.net.

Dr. Goyal is an academic hospitalist at the University of Alabama, Birmingham, and will continue to serve as a hospitalist and in the University’s urgent care system.



Nirupma Sharma, MD, has been named chief of the newly minted division of pediatric hospital medicine at Augusta (Ga.) University Health. Dr. Sharma will oversee the pediatric hospitalist staff, including education, research, and clinical assistance.

Dr. Sharma has been the medical director of the 4C unit at Children’s Hospital of Georgia in Augusta. She also has served as associate director of the Medical College of Georgia’s department of pediatrics clerkship program.

Dr. Vineet Arora

Vineet Arora, MD, MHM, was recently named one of the top 10 doctors to follow on Twitter by Becker’s Hospital Review. Dr. Arora is an academic hospitalist at University of Chicago Medicine.

Using the hashtag #meded, Dr. Arora provides a wealth of medical knowledge on Twitter, currently boasting more than 29,000 followers on that social media platform. She also serves as the Journal of Hospital Medicine’s deputy social media editor, and blogs about topics trending in resident education.
 

BUSINESS MOVES

Aspirus Iron River (Mich.) Hospital has partnered with iNDIGO Health Partners to create a telehealth hospitalist program at night. iNDIGO, a private hospitalist group, will utilize two-way video to treat Aspirus patients during overnight hours.

The telehealth providers with iNDIGO are part of the staff at Aspirus Iron River and are familiar with the facility’s procedures. The remote physicians will be in contact with staff at the hospital, providing direction after meeting with patients via the video system.

The Hospitals of Providence Memorial Campus in El Paso, Tex., intends to have specialists on site at all times for expectant mothers after recently adopting an obstetric hospitalist program. The OB hospitalists will be available to treat patient concerns and medical emergencies that occur outside of normal hours for patients’ primary obstetricians.

All OB hospitalists will be board-certified OB physicians. The goal is to decrease wait times for expectant mothers, who can receive immediate assessments and treatment upon arrival in the emergency department.






 

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Acute flaccid myelitis has unique MRI features

High index of suspicion required for AFM
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Acute flaccid myelitis appears to present most commonly as asymmetric weakness after respiratory viral infection and has distinctive MRI features that could help with early diagnosis.

In a paper published in JAMA Pediatrics, researchers presented the results of a retrospective case series of 45 children who were diagnosed between 2012 and 2016 with acute flaccid myelitis, or “pseudo polio,” using the Centers for Disease Control’s case definition.

Matthew J. Elrick, MD, PhD, of Johns Hopkins University, Baltimore, and his coauthors came up with a set of reproducible and distinctive features of acute flaccid myelitis. These were the presence of a prodromal fever or viral syndrome; weakness in a lower motor neuron pattern involving one or more limbs, neck, face, and/or bulbar muscles; supportive evidence either from MRI, nerve conduction studies, or cerebrospinal fluid; and the absence of objective sensory deficits, supratentorial white matter, cortical lesions greater than 1 cm in size, encephalopathy, elevated cerebrospinal fluid without pleocytosis, or any other alternative diagnosis.

The researchers commented that, while the CDC case definition has helped with epidemiologic surveillance of acute flaccid myelitis, it may also pick up children with acute weakness caused by other conditions such as transverse myelitis, Guillain-Barré syndrome, ischemic myelopathy, and other myelopathies.

To identify clinical features that might help differentiate patients with acute flaccid myelitis, the researchers attempted to see how many alternative diagnoses were captured in the CDC case definition.

The patients in their study all presented with acute flaccid paralysis in at least one limb and with either an MRI showing a spinal cord lesion spanning one or more spinal segments but largely restricted to gray matter or pleocytosis of the cerebrospinal fluid. The researchers divided the cases into those who also met a well-defined alternative diagnosis – who they categorized as “acute flaccid myelitis with possible alternative diagnosis” (AFM-ad) – and those who were categorized as “restrictively defined AFM” (rAFM). Overall, 34 patients were classified as rAFM and 11 as AFM-ad.

Those in the rAFD group nearly all had asymmetric onset of symptoms, while those in the AFM-ad group were more likely to experience bilateral onset in their lower extremities, “reflecting the pattern of symptoms often seen in other causes of myelopathy such as transverse myelitis and ischemic injury,” the authors noted.

While both groups often presented with decreased muscle tone and reflexes, this was more likely to evolve to increased tone or hyperreflexia in the AFM-ad group. Patients with AFM-ad were also more likely to experience impaired bowel or bladder function.

On MRI, lesions were mostly or completely restricted to the spinal cord gray matter in patients with rAFM or to involve the dorsal pons. These patients did not have any supratentorial brain lesions.

Patients in the rAFM category also had lower cerebrospinal fluid protein values than those in the AFM-ad category, but this was the only cerebrospinal fluid difference between the two groups.

All patients categorized as having rAFM had an infectious prodrome – such as viral syndrome, fever, congestion, and cough – compared with 63.6% of the patients categorized as AFM-ad. The pathogen was identified in only 13 of the rAFM patients, and included 5 patients with enterovirus D68, 2 with unspecified enterovirus, 2 with rhinovirus, 2 with adenovirus, and 2 with mycoplasma. Of the three patients in the AFM-ad group whose pathogen was identified, one had an untyped rhinovirus/enterovirus and mycoplasma, one had a rhinovirus B, and one had enterovirus D68.

“These results highlight that the CDC case definition, while appropriately sensitive for epidemiologic ascertainment of possible AFM cases, also encompasses other neurologic diseases that can cause acute weakness,” the authors wrote. However, they acknowledged that acute flaccid myelitis was still poorly understood and their own definition of the disease may change as more children are diagnosed.

“We propose that the definition of rAFM presented here be used as a starting point for developing inclusion and exclusion criteria for future research studies of AFM,” they wrote.

The study was supported by Johns Hopkins University, the Bart McLean Fund for Neuroimmunology Research, and Project Restore. Two authors reported funding from private industry outside the submitted work and five reported support from or involvement with research and funding bodies.

SOURCE: Elrick MJ et al. JAMA Pediatr. 2018 Nov 30. doi: 10.1001/jamapediatrics.2018.4890.
 

Body

 

Acute flaccid myelitis (AFM) initially presents subtly, complicating its diagnosis. Children present with a rapid onset of weakness that is associated with a febrile illness, which can be respiratory, gastrointestinal, or with symptoms of hand-foot-and-mouth disease. Given the lack of effective treatments, early diagnosis and monitoring are essential for mitigating the risk of respiratory decline and long-term complications.

While patient history and physical examination can provide clues to the presence of AFM, confirming the diagnosis requires lumbar puncture and MRI of the spinal cord. On MRI, diagnostic confirmation will come from findings of longitudinal, butterfly-shaped, anterior horn–predominant T2 and fluid-attenuated inversion recovery hyperintensities of the central gray matter.

Patients with suspected AFM should be hospitalized because they can rapidly deteriorate to the point of respiratory compromise, particularly those with upper extremity and bulbar weakness.

Sarah E. Hopkins, MD, is from the division of neurology at the Children’s Hospital of Philadelphia; Matthew J. Elrick, MD, PhD, is from the department of neurology at Johns Hopkins University, Baltimore; and Kevin Messacar, MD, is from the department of pediatrics at the Children’s Hospital Colorado. These comments are taken from an accompanying viewpoint (JAMA Pediatr. 2018 Nov 30. doi: 10.1001/jamapediatrics.2018.4896). Dr. Messacar reported support from the National Institutes of Health/National Institute of Allergy and Infectious and Dr. Hopkins reported support from the Centers for Disease Control and Prevention.

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Acute flaccid myelitis (AFM) initially presents subtly, complicating its diagnosis. Children present with a rapid onset of weakness that is associated with a febrile illness, which can be respiratory, gastrointestinal, or with symptoms of hand-foot-and-mouth disease. Given the lack of effective treatments, early diagnosis and monitoring are essential for mitigating the risk of respiratory decline and long-term complications.

While patient history and physical examination can provide clues to the presence of AFM, confirming the diagnosis requires lumbar puncture and MRI of the spinal cord. On MRI, diagnostic confirmation will come from findings of longitudinal, butterfly-shaped, anterior horn–predominant T2 and fluid-attenuated inversion recovery hyperintensities of the central gray matter.

Patients with suspected AFM should be hospitalized because they can rapidly deteriorate to the point of respiratory compromise, particularly those with upper extremity and bulbar weakness.

Sarah E. Hopkins, MD, is from the division of neurology at the Children’s Hospital of Philadelphia; Matthew J. Elrick, MD, PhD, is from the department of neurology at Johns Hopkins University, Baltimore; and Kevin Messacar, MD, is from the department of pediatrics at the Children’s Hospital Colorado. These comments are taken from an accompanying viewpoint (JAMA Pediatr. 2018 Nov 30. doi: 10.1001/jamapediatrics.2018.4896). Dr. Messacar reported support from the National Institutes of Health/National Institute of Allergy and Infectious and Dr. Hopkins reported support from the Centers for Disease Control and Prevention.

Body

 

Acute flaccid myelitis (AFM) initially presents subtly, complicating its diagnosis. Children present with a rapid onset of weakness that is associated with a febrile illness, which can be respiratory, gastrointestinal, or with symptoms of hand-foot-and-mouth disease. Given the lack of effective treatments, early diagnosis and monitoring are essential for mitigating the risk of respiratory decline and long-term complications.

While patient history and physical examination can provide clues to the presence of AFM, confirming the diagnosis requires lumbar puncture and MRI of the spinal cord. On MRI, diagnostic confirmation will come from findings of longitudinal, butterfly-shaped, anterior horn–predominant T2 and fluid-attenuated inversion recovery hyperintensities of the central gray matter.

Patients with suspected AFM should be hospitalized because they can rapidly deteriorate to the point of respiratory compromise, particularly those with upper extremity and bulbar weakness.

Sarah E. Hopkins, MD, is from the division of neurology at the Children’s Hospital of Philadelphia; Matthew J. Elrick, MD, PhD, is from the department of neurology at Johns Hopkins University, Baltimore; and Kevin Messacar, MD, is from the department of pediatrics at the Children’s Hospital Colorado. These comments are taken from an accompanying viewpoint (JAMA Pediatr. 2018 Nov 30. doi: 10.1001/jamapediatrics.2018.4896). Dr. Messacar reported support from the National Institutes of Health/National Institute of Allergy and Infectious and Dr. Hopkins reported support from the Centers for Disease Control and Prevention.

Title
High index of suspicion required for AFM
High index of suspicion required for AFM

 

Acute flaccid myelitis appears to present most commonly as asymmetric weakness after respiratory viral infection and has distinctive MRI features that could help with early diagnosis.

In a paper published in JAMA Pediatrics, researchers presented the results of a retrospective case series of 45 children who were diagnosed between 2012 and 2016 with acute flaccid myelitis, or “pseudo polio,” using the Centers for Disease Control’s case definition.

Matthew J. Elrick, MD, PhD, of Johns Hopkins University, Baltimore, and his coauthors came up with a set of reproducible and distinctive features of acute flaccid myelitis. These were the presence of a prodromal fever or viral syndrome; weakness in a lower motor neuron pattern involving one or more limbs, neck, face, and/or bulbar muscles; supportive evidence either from MRI, nerve conduction studies, or cerebrospinal fluid; and the absence of objective sensory deficits, supratentorial white matter, cortical lesions greater than 1 cm in size, encephalopathy, elevated cerebrospinal fluid without pleocytosis, or any other alternative diagnosis.

The researchers commented that, while the CDC case definition has helped with epidemiologic surveillance of acute flaccid myelitis, it may also pick up children with acute weakness caused by other conditions such as transverse myelitis, Guillain-Barré syndrome, ischemic myelopathy, and other myelopathies.

To identify clinical features that might help differentiate patients with acute flaccid myelitis, the researchers attempted to see how many alternative diagnoses were captured in the CDC case definition.

The patients in their study all presented with acute flaccid paralysis in at least one limb and with either an MRI showing a spinal cord lesion spanning one or more spinal segments but largely restricted to gray matter or pleocytosis of the cerebrospinal fluid. The researchers divided the cases into those who also met a well-defined alternative diagnosis – who they categorized as “acute flaccid myelitis with possible alternative diagnosis” (AFM-ad) – and those who were categorized as “restrictively defined AFM” (rAFM). Overall, 34 patients were classified as rAFM and 11 as AFM-ad.

Those in the rAFD group nearly all had asymmetric onset of symptoms, while those in the AFM-ad group were more likely to experience bilateral onset in their lower extremities, “reflecting the pattern of symptoms often seen in other causes of myelopathy such as transverse myelitis and ischemic injury,” the authors noted.

While both groups often presented with decreased muscle tone and reflexes, this was more likely to evolve to increased tone or hyperreflexia in the AFM-ad group. Patients with AFM-ad were also more likely to experience impaired bowel or bladder function.

On MRI, lesions were mostly or completely restricted to the spinal cord gray matter in patients with rAFM or to involve the dorsal pons. These patients did not have any supratentorial brain lesions.

Patients in the rAFM category also had lower cerebrospinal fluid protein values than those in the AFM-ad category, but this was the only cerebrospinal fluid difference between the two groups.

All patients categorized as having rAFM had an infectious prodrome – such as viral syndrome, fever, congestion, and cough – compared with 63.6% of the patients categorized as AFM-ad. The pathogen was identified in only 13 of the rAFM patients, and included 5 patients with enterovirus D68, 2 with unspecified enterovirus, 2 with rhinovirus, 2 with adenovirus, and 2 with mycoplasma. Of the three patients in the AFM-ad group whose pathogen was identified, one had an untyped rhinovirus/enterovirus and mycoplasma, one had a rhinovirus B, and one had enterovirus D68.

“These results highlight that the CDC case definition, while appropriately sensitive for epidemiologic ascertainment of possible AFM cases, also encompasses other neurologic diseases that can cause acute weakness,” the authors wrote. However, they acknowledged that acute flaccid myelitis was still poorly understood and their own definition of the disease may change as more children are diagnosed.

“We propose that the definition of rAFM presented here be used as a starting point for developing inclusion and exclusion criteria for future research studies of AFM,” they wrote.

The study was supported by Johns Hopkins University, the Bart McLean Fund for Neuroimmunology Research, and Project Restore. Two authors reported funding from private industry outside the submitted work and five reported support from or involvement with research and funding bodies.

SOURCE: Elrick MJ et al. JAMA Pediatr. 2018 Nov 30. doi: 10.1001/jamapediatrics.2018.4890.
 

 

Acute flaccid myelitis appears to present most commonly as asymmetric weakness after respiratory viral infection and has distinctive MRI features that could help with early diagnosis.

In a paper published in JAMA Pediatrics, researchers presented the results of a retrospective case series of 45 children who were diagnosed between 2012 and 2016 with acute flaccid myelitis, or “pseudo polio,” using the Centers for Disease Control’s case definition.

Matthew J. Elrick, MD, PhD, of Johns Hopkins University, Baltimore, and his coauthors came up with a set of reproducible and distinctive features of acute flaccid myelitis. These were the presence of a prodromal fever or viral syndrome; weakness in a lower motor neuron pattern involving one or more limbs, neck, face, and/or bulbar muscles; supportive evidence either from MRI, nerve conduction studies, or cerebrospinal fluid; and the absence of objective sensory deficits, supratentorial white matter, cortical lesions greater than 1 cm in size, encephalopathy, elevated cerebrospinal fluid without pleocytosis, or any other alternative diagnosis.

The researchers commented that, while the CDC case definition has helped with epidemiologic surveillance of acute flaccid myelitis, it may also pick up children with acute weakness caused by other conditions such as transverse myelitis, Guillain-Barré syndrome, ischemic myelopathy, and other myelopathies.

To identify clinical features that might help differentiate patients with acute flaccid myelitis, the researchers attempted to see how many alternative diagnoses were captured in the CDC case definition.

The patients in their study all presented with acute flaccid paralysis in at least one limb and with either an MRI showing a spinal cord lesion spanning one or more spinal segments but largely restricted to gray matter or pleocytosis of the cerebrospinal fluid. The researchers divided the cases into those who also met a well-defined alternative diagnosis – who they categorized as “acute flaccid myelitis with possible alternative diagnosis” (AFM-ad) – and those who were categorized as “restrictively defined AFM” (rAFM). Overall, 34 patients were classified as rAFM and 11 as AFM-ad.

Those in the rAFD group nearly all had asymmetric onset of symptoms, while those in the AFM-ad group were more likely to experience bilateral onset in their lower extremities, “reflecting the pattern of symptoms often seen in other causes of myelopathy such as transverse myelitis and ischemic injury,” the authors noted.

While both groups often presented with decreased muscle tone and reflexes, this was more likely to evolve to increased tone or hyperreflexia in the AFM-ad group. Patients with AFM-ad were also more likely to experience impaired bowel or bladder function.

On MRI, lesions were mostly or completely restricted to the spinal cord gray matter in patients with rAFM or to involve the dorsal pons. These patients did not have any supratentorial brain lesions.

Patients in the rAFM category also had lower cerebrospinal fluid protein values than those in the AFM-ad category, but this was the only cerebrospinal fluid difference between the two groups.

All patients categorized as having rAFM had an infectious prodrome – such as viral syndrome, fever, congestion, and cough – compared with 63.6% of the patients categorized as AFM-ad. The pathogen was identified in only 13 of the rAFM patients, and included 5 patients with enterovirus D68, 2 with unspecified enterovirus, 2 with rhinovirus, 2 with adenovirus, and 2 with mycoplasma. Of the three patients in the AFM-ad group whose pathogen was identified, one had an untyped rhinovirus/enterovirus and mycoplasma, one had a rhinovirus B, and one had enterovirus D68.

“These results highlight that the CDC case definition, while appropriately sensitive for epidemiologic ascertainment of possible AFM cases, also encompasses other neurologic diseases that can cause acute weakness,” the authors wrote. However, they acknowledged that acute flaccid myelitis was still poorly understood and their own definition of the disease may change as more children are diagnosed.

“We propose that the definition of rAFM presented here be used as a starting point for developing inclusion and exclusion criteria for future research studies of AFM,” they wrote.

The study was supported by Johns Hopkins University, the Bart McLean Fund for Neuroimmunology Research, and Project Restore. Two authors reported funding from private industry outside the submitted work and five reported support from or involvement with research and funding bodies.

SOURCE: Elrick MJ et al. JAMA Pediatr. 2018 Nov 30. doi: 10.1001/jamapediatrics.2018.4890.
 

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FROM JAMA PEDIATRICS

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Key clinical point: Acute flaccid myelitis has distinct features that can distinguish it from other similar conditions.

Major finding: Asymmetric onset of symptoms and MRI signature can help distinguish acute flaccid myelitis from alternative diagnoses.

Study details: A retrospective case series in 45 children diagnosed with acute flaccid myelitis.

Disclosures: The study was supported by Johns Hopkins University, the Bart McLean Fund for Neuroimmunology Research, and Project Restore. Two authors reported funding from private industry outside the submitted work and five reported support from or involvement with research and funding bodies.

Source: Elrick MJ et al. JAMA Pediatr. 2018 Nov 30. doi: 10.1001/jamapediatrics.2018.4890.

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Feds call for EHR interoperability. Again.

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– In what feels like a tradition, the need to solve interoperability issues was front and center once again as the key goal presented by Health and Human Services officials at the annual meeting of the Office of the National Coordinator.

Gregory Twachtman/MDedge News
HHS Deputy Secretary Eric Hargan addresses ONC 2018.

“It is actually impossible to move to a future health system, the one that we need ... without a truly interoperable system,” HHS Deputy Secretary Eric Hargan said Nov. 29 during a keynote address.

“Patients need to be able to access their own records. Period,” he added.

Mr. Hargan emphasized that the HHS will define what it wants to see regarding interoperability, but leave it up to vendors and developers to come up with solutions on how this will be accomplished.

One example that he mentioned is Blue Button 2.0, a part of the MyHealthEData initiative, which allows Medicare patients to connect their claims data to apps to help them make informed decisions about their care.

“The use of apps here reflects to potential, we believe, for patient-centered technology to improve health,” Mr. Hargan said.

He also noted that the agency is looking at how existing law and regulation – such as the antikickback statute, the Stark law, HIPAA, and federal privacy regulations – might be hindering the transition to value-based care.

This analysis is “specifically focused on understanding as quickly as we can ... how current interpretations of these laws may be impeding value-based transformation and coordinated care,” Mr. Hargan said.

ONC is also taking a look at reducing provider burden, issuing a draft strategy for comment that specifically targets provider burden related to the use of EHRs and offer up a series of recommendations to help address it.

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– In what feels like a tradition, the need to solve interoperability issues was front and center once again as the key goal presented by Health and Human Services officials at the annual meeting of the Office of the National Coordinator.

Gregory Twachtman/MDedge News
HHS Deputy Secretary Eric Hargan addresses ONC 2018.

“It is actually impossible to move to a future health system, the one that we need ... without a truly interoperable system,” HHS Deputy Secretary Eric Hargan said Nov. 29 during a keynote address.

“Patients need to be able to access their own records. Period,” he added.

Mr. Hargan emphasized that the HHS will define what it wants to see regarding interoperability, but leave it up to vendors and developers to come up with solutions on how this will be accomplished.

One example that he mentioned is Blue Button 2.0, a part of the MyHealthEData initiative, which allows Medicare patients to connect their claims data to apps to help them make informed decisions about their care.

“The use of apps here reflects to potential, we believe, for patient-centered technology to improve health,” Mr. Hargan said.

He also noted that the agency is looking at how existing law and regulation – such as the antikickback statute, the Stark law, HIPAA, and federal privacy regulations – might be hindering the transition to value-based care.

This analysis is “specifically focused on understanding as quickly as we can ... how current interpretations of these laws may be impeding value-based transformation and coordinated care,” Mr. Hargan said.

ONC is also taking a look at reducing provider burden, issuing a draft strategy for comment that specifically targets provider burden related to the use of EHRs and offer up a series of recommendations to help address it.

 

– In what feels like a tradition, the need to solve interoperability issues was front and center once again as the key goal presented by Health and Human Services officials at the annual meeting of the Office of the National Coordinator.

Gregory Twachtman/MDedge News
HHS Deputy Secretary Eric Hargan addresses ONC 2018.

“It is actually impossible to move to a future health system, the one that we need ... without a truly interoperable system,” HHS Deputy Secretary Eric Hargan said Nov. 29 during a keynote address.

“Patients need to be able to access their own records. Period,” he added.

Mr. Hargan emphasized that the HHS will define what it wants to see regarding interoperability, but leave it up to vendors and developers to come up with solutions on how this will be accomplished.

One example that he mentioned is Blue Button 2.0, a part of the MyHealthEData initiative, which allows Medicare patients to connect their claims data to apps to help them make informed decisions about their care.

“The use of apps here reflects to potential, we believe, for patient-centered technology to improve health,” Mr. Hargan said.

He also noted that the agency is looking at how existing law and regulation – such as the antikickback statute, the Stark law, HIPAA, and federal privacy regulations – might be hindering the transition to value-based care.

This analysis is “specifically focused on understanding as quickly as we can ... how current interpretations of these laws may be impeding value-based transformation and coordinated care,” Mr. Hargan said.

ONC is also taking a look at reducing provider burden, issuing a draft strategy for comment that specifically targets provider burden related to the use of EHRs and offer up a series of recommendations to help address it.

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REPORTING FROM ONC 2018

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