The Hospitalist

Ever wish you had more leadership training in medical school or your residency programs? Feel a bit overwhelmed when developing operational plans for your hospital or negotiating important contracts? Join SHM in sunny Lake Buena Vista, Fla., October 24–27, for its esteemed Leadership Academy (www.shmleadershipacademy.org). SHM Leadership Academy prepares clinicians, academicians, and administrators with vital leadership skills traditionally not taught throughout the course of medical training, tailored specifically to hospital medicine.

“SHM’s Leadership Academy teaches leadership skills for individuals all across the spectrum of the hospital team. My experience helped me to raise the bar not only to benefit myself but also my institution and especially my patients,” says Ron Greeno, MD, MHM. “I highly recommend this experience to any hospital medicine professionals who aspire to take their leadership skills to the next level.”

All three courses run concurrently over the span of the four days and are led by world-renowned faculty. This expanded meeting will provide attendees with unprecedented networking opportunities with hundreds of colleagues and enhanced career development.

Available Leadership Academy courses include:

• Leadership Foundations, a four-day course that serves as the first step in your leadership journey. Attendees learn how to evaluate personal leadership strengths and weaknesses, create and execute a communication strategy for key team members, understand key hospital drivers, examine how hospital metrics are derived, and much more. Attendees are divided into smaller moderated groups to ensure meaningful, relevant application of concepts to hands-on activities.
• Advanced Leadership: Influential Management, a course that builds skills around driving culture change through specific leadership behaviors and actions, financial storytelling, engaging in effective professional negotiation activities with proven techniques, and more through world-renowned faculty and applied exercises.

  (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval)

• Advanced Leadership: Mastering Teamwork, a course developed in response to high demand from previous Leadership Academy attendees. Participants learn how to critically assess program growth opportunities and develop operational plans; utilize the principles of SWARM intelligence; lead, manage, and motivate teams in complex hospital environments; and develop effective communication strategies.

  (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)

SHM members receive reduced rates for course tuition. For more information on how to register, visit www.SHMLeadershipAcademy.org.

Ever wish you had more leadership training in medical school or your residency programs? Feel a bit overwhelmed when developing operational plans for your hospital or negotiating important contracts? Join SHM in sunny Lake Buena Vista, Fla., October 24–27, for its esteemed Leadership Academy (www.shmleadershipacademy.org). SHM Leadership Academy prepares clinicians, academicians, and administrators with vital leadership skills traditionally not taught throughout the course of medical training, tailored specifically to hospital medicine.

“SHM’s Leadership Academy teaches leadership skills for individuals all across the spectrum of the hospital team. My experience helped me to raise the bar not only to benefit myself but also my institution and especially my patients,” says Ron Greeno, MD, MHM. “I highly recommend this experience to any hospital medicine professionals who aspire to take their leadership skills to the next level.”

All three courses run concurrently over the span of the four days and are led by world-renowned faculty. This expanded meeting will provide attendees with unprecedented networking opportunities with hundreds of colleagues and enhanced career development.

Available Leadership Academy courses include:

• Leadership Foundations, a four-day course that serves as the first step in your leadership journey. Attendees learn how to evaluate personal leadership strengths and weaknesses, create and execute a communication strategy for key team members, understand key hospital drivers, examine how hospital metrics are derived, and much more. Attendees are divided into smaller moderated groups to ensure meaningful, relevant application of concepts to hands-on activities.
• Advanced Leadership: Influential Management, a course that builds skills around driving culture change through specific leadership behaviors and actions, financial storytelling, engaging in effective professional negotiation activities with proven techniques, and more through world-renowned faculty and applied exercises.

  (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval)

• Advanced Leadership: Mastering Teamwork, a course developed in response to high demand from previous Leadership Academy attendees. Participants learn how to critically assess program growth opportunities and develop operational plans; utilize the principles of SWARM intelligence; lead, manage, and motivate teams in complex hospital environments; and develop effective communication strategies.

  (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)

SHM members receive reduced rates for course tuition. For more information on how to register, visit www.SHMLeadershipAcademy.org.

Ever wish you had more leadership training in medical school or your residency programs? Feel a bit overwhelmed when developing operational plans for your hospital or negotiating important contracts? Join SHM in sunny Lake Buena Vista, Fla., October 24–27, for its esteemed Leadership Academy (www.shmleadershipacademy.org). SHM Leadership Academy prepares clinicians, academicians, and administrators with vital leadership skills traditionally not taught throughout the course of medical training, tailored specifically to hospital medicine.

“SHM’s Leadership Academy teaches leadership skills for individuals all across the spectrum of the hospital team. My experience helped me to raise the bar not only to benefit myself but also my institution and especially my patients,” says Ron Greeno, MD, MHM. “I highly recommend this experience to any hospital medicine professionals who aspire to take their leadership skills to the next level.”

All three courses run concurrently over the span of the four days and are led by world-renowned faculty. This expanded meeting will provide attendees with unprecedented networking opportunities with hundreds of colleagues and enhanced career development.

Available Leadership Academy courses include:

• Leadership Foundations, a four-day course that serves as the first step in your leadership journey. Attendees learn how to evaluate personal leadership strengths and weaknesses, create and execute a communication strategy for key team members, understand key hospital drivers, examine how hospital metrics are derived, and much more. Attendees are divided into smaller moderated groups to ensure meaningful, relevant application of concepts to hands-on activities.
• Advanced Leadership: Influential Management, a course that builds skills around driving culture change through specific leadership behaviors and actions, financial storytelling, engaging in effective professional negotiation activities with proven techniques, and more through world-renowned faculty and applied exercises.

  (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval)

• Advanced Leadership: Mastering Teamwork, a course developed in response to high demand from previous Leadership Academy attendees. Participants learn how to critically assess program growth opportunities and develop operational plans; utilize the principles of SWARM intelligence; lead, manage, and motivate teams in complex hospital environments; and develop effective communication strategies.

  (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)

SHM members receive reduced rates for course tuition. For more information on how to register, visit www.SHMLeadershipAcademy.org.

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

Clinical question: Can venous thromboembolism prophylaxis (VTEP) guidelines be systematically implemented in a pediatric inpatient population?

Background: VTEP for hospitalized adult medical patients has been characterized in the literature as being safe and efficacious, although mortality benefits are unclear.1 Systematic risk stratification based on electronic medical records (EMRs) with resultant implementation of pharmacologic and mechanical thromboprophylaxis has been shown to improve appropriate VTEP ordering in the adult inpatient population.2

Although the incidence of VTE is known to be increasing in the pediatric population, systematic VTEP implementation in hospitalized children is not well-described. Prior studies have shown the safety of systematic VTEP implementation through a protocol identifying high-risk pediatric inpatients with resultant initiation of appropriate VTEP. 3,4

Risk stratification in prior studies has taken into consideration risk factors such as altered mobility, presence of a central venous catheter (CVC), spinal cord injury (SCI), major lower-extremity orthopedic surgery, major trauma, active malignancy, acute infection, obesity, estrogen use, inflammatory bowel disease (IBD), prior VTE, and family history of VTE.4

Study design: Prospective cohort study using QI methodology.

Setting: A 455-bed, tertiary, freestanding children’s hospital.

Synopsis: After reviewing current literature for VTEP in adults and children and existing institutional pathways for VTEP in adults, traumatic brain injury, and SCI, a multidisciplinary committee formulated VTEP guidelines for 12- to 17-year-old patients. Pharmacologic prophylaxis was considered appropriate in the absence of contraindications and only if CVC and altered mobility were present as risk factors. Using a previously published logistic regression model evaluating VTE risk factors, patients were further categorized as high, moderate, or low risk.

Initial risk-factor categorization was via EMR-based order set, where risk factors were displayed, but subsequently was performed by an integrated tool based on an initial screening form completed by providers upon admission. Logic rules applied by the EMR led to specific VTEP recommendations, which were then selectable by the provider.

Over the first 17 months of EMR tool use, 148 patients on average were admitted each month. VTEP screening rates via the EMR tool increased from 48% in the first month to 81% in the final month. Despite EMR tool usage, VTEP orders did not always correlate with recommendations. Although not a stated objective of the study, none of the screened patients developed a VTE (compared to three cases of VTE in patients between 12 and 17 years of age the year prior).

Bottom line: VTEP guidelines can be systematically implemented via an EMR-based tool in a pediatric inpatient population.

Citation: Mahajerin A, Webber E, Morris J, Taylor K, Saysana M. Development and implementation results of a venous thromboembolism prophylaxis guideline in a tertiary care pediatric hospital. Hosp Pediatr. 2015;5(12):630-636.

References

1. Spyropoulos AC, Mahan C. Venous thromboembolism prophylaxis in the medical patient: controversies and perspectives. Am J Med. 2009;122(12):1077-1084.
2. Kahn SR, Morrison DR, Cohen JM, et al. Interventions for implementation of thromboprophylaxis in hospitalized medical and surgical patients at risk for venous thromboembolism. Cochrane Database Syst Rev. 2013;7:CD008201.
3. Takemoto CM, Sohi S, Desai K, et al. Hospital-associated venous thromboembolism in children: incidence and clinical characteristics. J Pediatr. 2014;164(2):332-338.
4. Raffini L, Trimarchi T, Beliveau J, Davis D. Thromboprophylaxis in a pediatric hospital: a patient-safety and quality-improvement initiative. Pediatrics. 2011;127(5):e1326-1332.

Clinical question: Can venous thromboembolism prophylaxis (VTEP) guidelines be systematically implemented in a pediatric inpatient population?

Background: VTEP for hospitalized adult medical patients has been characterized in the literature as being safe and efficacious, although mortality benefits are unclear.1 Systematic risk stratification based on electronic medical records (EMRs) with resultant implementation of pharmacologic and mechanical thromboprophylaxis has been shown to improve appropriate VTEP ordering in the adult inpatient population.2

Although the incidence of VTE is known to be increasing in the pediatric population, systematic VTEP implementation in hospitalized children is not well-described. Prior studies have shown the safety of systematic VTEP implementation through a protocol identifying high-risk pediatric inpatients with resultant initiation of appropriate VTEP. 3,4

Risk stratification in prior studies has taken into consideration risk factors such as altered mobility, presence of a central venous catheter (CVC), spinal cord injury (SCI), major lower-extremity orthopedic surgery, major trauma, active malignancy, acute infection, obesity, estrogen use, inflammatory bowel disease (IBD), prior VTE, and family history of VTE.4

Study design: Prospective cohort study using QI methodology.

Setting: A 455-bed, tertiary, freestanding children’s hospital.

Synopsis: After reviewing current literature for VTEP in adults and children and existing institutional pathways for VTEP in adults, traumatic brain injury, and SCI, a multidisciplinary committee formulated VTEP guidelines for 12- to 17-year-old patients. Pharmacologic prophylaxis was considered appropriate in the absence of contraindications and only if CVC and altered mobility were present as risk factors. Using a previously published logistic regression model evaluating VTE risk factors, patients were further categorized as high, moderate, or low risk.

Initial risk-factor categorization was via EMR-based order set, where risk factors were displayed, but subsequently was performed by an integrated tool based on an initial screening form completed by providers upon admission. Logic rules applied by the EMR led to specific VTEP recommendations, which were then selectable by the provider.

Over the first 17 months of EMR tool use, 148 patients on average were admitted each month. VTEP screening rates via the EMR tool increased from 48% in the first month to 81% in the final month. Despite EMR tool usage, VTEP orders did not always correlate with recommendations. Although not a stated objective of the study, none of the screened patients developed a VTE (compared to three cases of VTE in patients between 12 and 17 years of age the year prior).

Bottom line: VTEP guidelines can be systematically implemented via an EMR-based tool in a pediatric inpatient population.

Citation: Mahajerin A, Webber E, Morris J, Taylor K, Saysana M. Development and implementation results of a venous thromboembolism prophylaxis guideline in a tertiary care pediatric hospital. Hosp Pediatr. 2015;5(12):630-636.

References

1. Spyropoulos AC, Mahan C. Venous thromboembolism prophylaxis in the medical patient: controversies and perspectives. Am J Med. 2009;122(12):1077-1084.
2. Kahn SR, Morrison DR, Cohen JM, et al. Interventions for implementation of thromboprophylaxis in hospitalized medical and surgical patients at risk for venous thromboembolism. Cochrane Database Syst Rev. 2013;7:CD008201.
3. Takemoto CM, Sohi S, Desai K, et al. Hospital-associated venous thromboembolism in children: incidence and clinical characteristics. J Pediatr. 2014;164(2):332-338.
4. Raffini L, Trimarchi T, Beliveau J, Davis D. Thromboprophylaxis in a pediatric hospital: a patient-safety and quality-improvement initiative. Pediatrics. 2011;127(5):e1326-1332.

Clinical question: Can venous thromboembolism prophylaxis (VTEP) guidelines be systematically implemented in a pediatric inpatient population?

Background: VTEP for hospitalized adult medical patients has been characterized in the literature as being safe and efficacious, although mortality benefits are unclear.1 Systematic risk stratification based on electronic medical records (EMRs) with resultant implementation of pharmacologic and mechanical thromboprophylaxis has been shown to improve appropriate VTEP ordering in the adult inpatient population.2

Although the incidence of VTE is known to be increasing in the pediatric population, systematic VTEP implementation in hospitalized children is not well-described. Prior studies have shown the safety of systematic VTEP implementation through a protocol identifying high-risk pediatric inpatients with resultant initiation of appropriate VTEP. 3,4

Risk stratification in prior studies has taken into consideration risk factors such as altered mobility, presence of a central venous catheter (CVC), spinal cord injury (SCI), major lower-extremity orthopedic surgery, major trauma, active malignancy, acute infection, obesity, estrogen use, inflammatory bowel disease (IBD), prior VTE, and family history of VTE.4

Study design: Prospective cohort study using QI methodology.

Setting: A 455-bed, tertiary, freestanding children’s hospital.

Synopsis: After reviewing current literature for VTEP in adults and children and existing institutional pathways for VTEP in adults, traumatic brain injury, and SCI, a multidisciplinary committee formulated VTEP guidelines for 12- to 17-year-old patients. Pharmacologic prophylaxis was considered appropriate in the absence of contraindications and only if CVC and altered mobility were present as risk factors. Using a previously published logistic regression model evaluating VTE risk factors, patients were further categorized as high, moderate, or low risk.

Initial risk-factor categorization was via EMR-based order set, where risk factors were displayed, but subsequently was performed by an integrated tool based on an initial screening form completed by providers upon admission. Logic rules applied by the EMR led to specific VTEP recommendations, which were then selectable by the provider.

Over the first 17 months of EMR tool use, 148 patients on average were admitted each month. VTEP screening rates via the EMR tool increased from 48% in the first month to 81% in the final month. Despite EMR tool usage, VTEP orders did not always correlate with recommendations. Although not a stated objective of the study, none of the screened patients developed a VTE (compared to three cases of VTE in patients between 12 and 17 years of age the year prior).

Bottom line: VTEP guidelines can be systematically implemented via an EMR-based tool in a pediatric inpatient population.

Citation: Mahajerin A, Webber E, Morris J, Taylor K, Saysana M. Development and implementation results of a venous thromboembolism prophylaxis guideline in a tertiary care pediatric hospital. Hosp Pediatr. 2015;5(12):630-636.

References

1. Spyropoulos AC, Mahan C. Venous thromboembolism prophylaxis in the medical patient: controversies and perspectives. Am J Med. 2009;122(12):1077-1084.
2. Kahn SR, Morrison DR, Cohen JM, et al. Interventions for implementation of thromboprophylaxis in hospitalized medical and surgical patients at risk for venous thromboembolism. Cochrane Database Syst Rev. 2013;7:CD008201.
3. Takemoto CM, Sohi S, Desai K, et al. Hospital-associated venous thromboembolism in children: incidence and clinical characteristics. J Pediatr. 2014;164(2):332-338.
4. Raffini L, Trimarchi T, Beliveau J, Davis D. Thromboprophylaxis in a pediatric hospital: a patient-safety and quality-improvement initiative. Pediatrics. 2011;127(5):e1326-1332.

(Reuters) - U.S. government scientists have raised questions about the potential risks to patients of heart attacks and blood clots from Abbott Laboratories' novel coronary stent that dissolves after it is implanted.

Abbott is seeking U.S. approval to sell the stent, called Absorb, as an alternative to metal stents currently used in percutaneous coronary intervention. Unlike traditional stents that remain in place after implantation, Absorb is designed to disappear within three years of the procedure.

U.S. Food and Drug Administration staff, in documents released before an advisory panel meets on Tuesday to consider whether to recommend approval of the device, said they would ask the outside experts about data showing more heart attack and stent-related blood clots compared with Abbott's drug-coated metal Xience stent.

FDA said it also will ask the panel to address risks associated with the device when used in smaller arteries.

A large clinical trial released in October concluded that the Absorb stent, which is made of a plastic similar to dissolving sutures, was comparable to Xience in overall safety and effectiveness. Although Xience appeared to be numerically better than Absorb at one year on a variety of secondary measures, the differences were not considered statistically significant.

"These results are from physicians using a new therapy for the first time. Consequently, we expect them to improve with time and experience," said Abbott spokesman Jonathon Hamilton.

In the Absorb III clinical study, patients with small vessels comprised less than 20 percent of the total and experienced relatively low rates of adverse events even though many had known risk factors, including diabetes, Hamilton said.

More than 125,000 patients already have been treated with Absorb in more than 100 countries where it is commercially available.

If approved in the United States, Absorb would compete with Xience, the market-leading stent, and with Medtronic Plc's Resolute stent and Boston Scientific's Synergy and Promus stents. Synergy's polymer coating used to deliver a drug disappears over time, leaving a bare metal stent in place.

Wells Fargo analyst Larry Biegelsen said he expects Absorb to get a positive recommendation from the advisory panel, followed by FDA approval later this year.

"In the U.S., we estimate Absorb will capture about 5 percent of the total drug-eluting stent market, although our estimate may prove conservative if the post-approval data and experience with Absorb improves," Biegelsen wrote in a note to clients.

(Reuters) - U.S. government scientists have raised questions about the potential risks to patients of heart attacks and blood clots from Abbott Laboratories' novel coronary stent that dissolves after it is implanted.

Abbott is seeking U.S. approval to sell the stent, called Absorb, as an alternative to metal stents currently used in percutaneous coronary intervention. Unlike traditional stents that remain in place after implantation, Absorb is designed to disappear within three years of the procedure.

U.S. Food and Drug Administration staff, in documents released before an advisory panel meets on Tuesday to consider whether to recommend approval of the device, said they would ask the outside experts about data showing more heart attack and stent-related blood clots compared with Abbott's drug-coated metal Xience stent.

FDA said it also will ask the panel to address risks associated with the device when used in smaller arteries.

A large clinical trial released in October concluded that the Absorb stent, which is made of a plastic similar to dissolving sutures, was comparable to Xience in overall safety and effectiveness. Although Xience appeared to be numerically better than Absorb at one year on a variety of secondary measures, the differences were not considered statistically significant.

"These results are from physicians using a new therapy for the first time. Consequently, we expect them to improve with time and experience," said Abbott spokesman Jonathon Hamilton.

In the Absorb III clinical study, patients with small vessels comprised less than 20 percent of the total and experienced relatively low rates of adverse events even though many had known risk factors, including diabetes, Hamilton said.

More than 125,000 patients already have been treated with Absorb in more than 100 countries where it is commercially available.

If approved in the United States, Absorb would compete with Xience, the market-leading stent, and with Medtronic Plc's Resolute stent and Boston Scientific's Synergy and Promus stents. Synergy's polymer coating used to deliver a drug disappears over time, leaving a bare metal stent in place.

Wells Fargo analyst Larry Biegelsen said he expects Absorb to get a positive recommendation from the advisory panel, followed by FDA approval later this year.

"In the U.S., we estimate Absorb will capture about 5 percent of the total drug-eluting stent market, although our estimate may prove conservative if the post-approval data and experience with Absorb improves," Biegelsen wrote in a note to clients.

(Reuters) - U.S. government scientists have raised questions about the potential risks to patients of heart attacks and blood clots from Abbott Laboratories' novel coronary stent that dissolves after it is implanted.

Abbott is seeking U.S. approval to sell the stent, called Absorb, as an alternative to metal stents currently used in percutaneous coronary intervention. Unlike traditional stents that remain in place after implantation, Absorb is designed to disappear within three years of the procedure.

U.S. Food and Drug Administration staff, in documents released before an advisory panel meets on Tuesday to consider whether to recommend approval of the device, said they would ask the outside experts about data showing more heart attack and stent-related blood clots compared with Abbott's drug-coated metal Xience stent.

FDA said it also will ask the panel to address risks associated with the device when used in smaller arteries.

A large clinical trial released in October concluded that the Absorb stent, which is made of a plastic similar to dissolving sutures, was comparable to Xience in overall safety and effectiveness. Although Xience appeared to be numerically better than Absorb at one year on a variety of secondary measures, the differences were not considered statistically significant.

"These results are from physicians using a new therapy for the first time. Consequently, we expect them to improve with time and experience," said Abbott spokesman Jonathon Hamilton.

In the Absorb III clinical study, patients with small vessels comprised less than 20 percent of the total and experienced relatively low rates of adverse events even though many had known risk factors, including diabetes, Hamilton said.

More than 125,000 patients already have been treated with Absorb in more than 100 countries where it is commercially available.

If approved in the United States, Absorb would compete with Xience, the market-leading stent, and with Medtronic Plc's Resolute stent and Boston Scientific's Synergy and Promus stents. Synergy's polymer coating used to deliver a drug disappears over time, leaving a bare metal stent in place.

Wells Fargo analyst Larry Biegelsen said he expects Absorb to get a positive recommendation from the advisory panel, followed by FDA approval later this year.

"In the U.S., we estimate Absorb will capture about 5 percent of the total drug-eluting stent market, although our estimate may prove conservative if the post-approval data and experience with Absorb improves," Biegelsen wrote in a note to clients.

K. Terrell, MD, Alabama

W. Burt, Arkansas

O. Shill, Arizona

S. Akhtar, MD, California

G. Andonian, California

E. Blecharczy, MD, FAAP, California

P. Febres, MD, California

C. Green, MD, California

C. Ha, California

R. Haile-Meskale, California

M. Hakimipour, MD, California

R. Hanemann, California

S. Khachoyan, California

M. Mahig, MD, California

R. Matson, California

K. McBride, California

M. Miles, BSN, MHA, MS, RN, California

P. Morales, California

J. Tannous, California

N. Aryee Tetteh, California

G. Thompson, California

I. Thomlinson, California

R. Valand, MPH, California

G. L. Wergowske, MD, California

S. Clyne, Colorado

J. Valentin, MD, FACP, Colorado

A. Noonan, APRN, Connecticut

J. Samuel, MD, Connecticut

D. Schillinger, Florida

N. Fobi-Nunga, Georgia

C. Troutman, RN, Georgia

I. Molano, MD, Iowa

Z. Abbas, Illinois

J. Burton, Illinois

F. Chowdhury, Illinois

S. Patel, MD, Illinois

M. Knutson, DO, Indiana

E. Wanas, MD, Indiana

B. E. Bradley, MBChB, Kentucky

T. Jetha, Louisiana

N. Melendez-Rios, MD, Massachusetts

A. Miskiv, Massachusetts

K. Nakashima, MD, Massachusetts

P. Pilegi, ACNP, Massachusetts

E. Shannon, Massachusetts

N. Singh, Massachusetts

R. Thatte, MD, Massachusetts

J. Viola, Massachusetts

J. Bie, CRNP, Maryland

C. Lafeer, Maryland

J. Mignano, Maryland

H. Jarawan, Maine

D. Stein, DO, Maine

S. Franso, MD, Michigan

T. LaBonte, MD, Michigan

D. Malaka, MD, MPH, Michigan

A. Miller, Minnesota

M. Usher, MD, PhD, Minnesota

M. Brinkmeier, MD, Missouri

S. Hassan, Missouri

R. Pitts, MD, Missouri

J. Sorg, MD, Missouri

M. Vaughan, Mississippi

C. Brown, ACMPE, North Carolina

D. Ghiassi, North Carolina

J. Hoffman, North Carolina

C. Norman, MS, PA-C, North Carolina

K. McDonald, MD, Nebraska

Y. Melnikova, MD, New Hampshire

J. Adigun, MD, New Jersey

S. Bhatt, MD, New Jersey

K. Bhavsar, New Jersey

S. Griggs, ANP, New York

G. Jabbour, New York

K. Kang, New York

P. Kayi, MD, New York

C. Lopez, MD, MPH, New York

O. Olafisoye, MD, New York

J. K. Salvani, MD, New York

M. Shinwa, New York

P. Wander, New York

S. Boyle, Ohio

S. Goates, Ohio

A. Hochhausler, MD, Ohio

V. Jayanti, Ohio

D. Kassay, CNP, Ohio

K. Welch, Ohio

J. Retson, CCFP, Ontario

V. Cheng, Pennsylvania

G. Chong, Pennsylvania

J. Hart, MD, Pennsylvania

M. M. Scoulos-Hanson, Pennsylvania

M. Shelkin, DO, Pennsylvania

S. Freeman, Rhode Island

G. Hussain, Rhode Island

R. Ulrich, PA-C, South Carolina

K. Inama, APRN-BC, South Dakota

S. Bray, Saskatchewan

D. E. Adams III, MD, Tennessee

I. Ellis, MD, Tennessee

C. Parrish, Tennessee

K. San, MC, USAR, Tennessee

A. Ahmed, MD, Texas

Z. Conrad, Texas

A. Iqbal, MD, Texas

J. Jamullamudi, MD, Texas

W. Mallot, Texas

C. Okoro, MD, Texas

C. Shy, Texas

P. Vankawala, Texas

L. Walker, Texas

D. Glodowski, MD, Utah

K. Brunson, NP, Virginia

E. Caldwell, Virginia

M. H. Chouindard, MD, Virginia

S. Edwards, MD, Virginia

S. Feldmann, Virginia

D. Kadariya, MBBS, MD, Virginia

J. Lachar, MBBS, MD, Virginia

B. Queen, MD, Virginia

A. M. Shamas, MD, Virginia

A. Wong, MD, Virginia

T. Chang, Washington

E. Gorbacheva, MD, Washington

Z. Li, PA-C, Washington

I. Murray, PA-C, Washington

M. Schaffer, MD, Washington

M. Stolzberg, Washington

K. Miller, MD, Wisconsin

C. Ranheim, MD, Wisconsin

A. Vincent, Wisconsin

J. Yi, DO, West Virginia

K. Han

S. Pannick

Y. Tan

K. Terrell, MD, Alabama

W. Burt, Arkansas

O. Shill, Arizona

S. Akhtar, MD, California

G. Andonian, California

E. Blecharczy, MD, FAAP, California

P. Febres, MD, California

C. Green, MD, California

C. Ha, California

R. Haile-Meskale, California

M. Hakimipour, MD, California

R. Hanemann, California

S. Khachoyan, California

M. Mahig, MD, California

R. Matson, California

K. McBride, California

M. Miles, BSN, MHA, MS, RN, California

P. Morales, California

J. Tannous, California

N. Aryee Tetteh, California

G. Thompson, California

I. Thomlinson, California

R. Valand, MPH, California

G. L. Wergowske, MD, California

S. Clyne, Colorado

J. Valentin, MD, FACP, Colorado

A. Noonan, APRN, Connecticut

J. Samuel, MD, Connecticut

D. Schillinger, Florida

N. Fobi-Nunga, Georgia

C. Troutman, RN, Georgia

I. Molano, MD, Iowa

Z. Abbas, Illinois

J. Burton, Illinois

F. Chowdhury, Illinois

S. Patel, MD, Illinois

M. Knutson, DO, Indiana

E. Wanas, MD, Indiana

B. E. Bradley, MBChB, Kentucky

T. Jetha, Louisiana

N. Melendez-Rios, MD, Massachusetts

A. Miskiv, Massachusetts

K. Nakashima, MD, Massachusetts

P. Pilegi, ACNP, Massachusetts

E. Shannon, Massachusetts

N. Singh, Massachusetts

R. Thatte, MD, Massachusetts

J. Viola, Massachusetts

J. Bie, CRNP, Maryland

C. Lafeer, Maryland

J. Mignano, Maryland

H. Jarawan, Maine

D. Stein, DO, Maine

S. Franso, MD, Michigan

T. LaBonte, MD, Michigan

D. Malaka, MD, MPH, Michigan

A. Miller, Minnesota

M. Usher, MD, PhD, Minnesota

M. Brinkmeier, MD, Missouri

S. Hassan, Missouri

R. Pitts, MD, Missouri

J. Sorg, MD, Missouri

M. Vaughan, Mississippi

C. Brown, ACMPE, North Carolina

D. Ghiassi, North Carolina

J. Hoffman, North Carolina

C. Norman, MS, PA-C, North Carolina

K. McDonald, MD, Nebraska

Y. Melnikova, MD, New Hampshire

J. Adigun, MD, New Jersey

S. Bhatt, MD, New Jersey

K. Bhavsar, New Jersey

S. Griggs, ANP, New York

G. Jabbour, New York

K. Kang, New York

P. Kayi, MD, New York

C. Lopez, MD, MPH, New York

O. Olafisoye, MD, New York

J. K. Salvani, MD, New York

M. Shinwa, New York

P. Wander, New York

S. Boyle, Ohio

S. Goates, Ohio

A. Hochhausler, MD, Ohio

V. Jayanti, Ohio

D. Kassay, CNP, Ohio

K. Welch, Ohio

J. Retson, CCFP, Ontario

V. Cheng, Pennsylvania

G. Chong, Pennsylvania

J. Hart, MD, Pennsylvania

M. M. Scoulos-Hanson, Pennsylvania

M. Shelkin, DO, Pennsylvania

S. Freeman, Rhode Island

G. Hussain, Rhode Island

R. Ulrich, PA-C, South Carolina

K. Inama, APRN-BC, South Dakota

S. Bray, Saskatchewan

D. E. Adams III, MD, Tennessee

I. Ellis, MD, Tennessee

C. Parrish, Tennessee

K. San, MC, USAR, Tennessee

A. Ahmed, MD, Texas

Z. Conrad, Texas

A. Iqbal, MD, Texas

J. Jamullamudi, MD, Texas

W. Mallot, Texas

C. Okoro, MD, Texas

C. Shy, Texas

P. Vankawala, Texas

L. Walker, Texas

D. Glodowski, MD, Utah

K. Brunson, NP, Virginia

E. Caldwell, Virginia

M. H. Chouindard, MD, Virginia

S. Edwards, MD, Virginia

S. Feldmann, Virginia

D. Kadariya, MBBS, MD, Virginia

J. Lachar, MBBS, MD, Virginia

B. Queen, MD, Virginia

A. M. Shamas, MD, Virginia

A. Wong, MD, Virginia

T. Chang, Washington

E. Gorbacheva, MD, Washington

Z. Li, PA-C, Washington

I. Murray, PA-C, Washington

M. Schaffer, MD, Washington

M. Stolzberg, Washington

K. Miller, MD, Wisconsin

C. Ranheim, MD, Wisconsin

A. Vincent, Wisconsin

J. Yi, DO, West Virginia

K. Han

S. Pannick

Y. Tan

K. Terrell, MD, Alabama

W. Burt, Arkansas

O. Shill, Arizona

S. Akhtar, MD, California

G. Andonian, California

E. Blecharczy, MD, FAAP, California

P. Febres, MD, California

C. Green, MD, California

C. Ha, California

R. Haile-Meskale, California

M. Hakimipour, MD, California

R. Hanemann, California

S. Khachoyan, California

M. Mahig, MD, California

R. Matson, California

K. McBride, California

M. Miles, BSN, MHA, MS, RN, California

P. Morales, California

J. Tannous, California

N. Aryee Tetteh, California

G. Thompson, California

I. Thomlinson, California

R. Valand, MPH, California

G. L. Wergowske, MD, California

S. Clyne, Colorado

J. Valentin, MD, FACP, Colorado

A. Noonan, APRN, Connecticut

J. Samuel, MD, Connecticut

D. Schillinger, Florida

N. Fobi-Nunga, Georgia

C. Troutman, RN, Georgia

I. Molano, MD, Iowa

Z. Abbas, Illinois

J. Burton, Illinois

F. Chowdhury, Illinois

S. Patel, MD, Illinois

M. Knutson, DO, Indiana

E. Wanas, MD, Indiana

B. E. Bradley, MBChB, Kentucky

T. Jetha, Louisiana

N. Melendez-Rios, MD, Massachusetts

A. Miskiv, Massachusetts

K. Nakashima, MD, Massachusetts

P. Pilegi, ACNP, Massachusetts

E. Shannon, Massachusetts

N. Singh, Massachusetts

R. Thatte, MD, Massachusetts

J. Viola, Massachusetts

J. Bie, CRNP, Maryland

C. Lafeer, Maryland

J. Mignano, Maryland

H. Jarawan, Maine

D. Stein, DO, Maine

S. Franso, MD, Michigan

T. LaBonte, MD, Michigan

D. Malaka, MD, MPH, Michigan

A. Miller, Minnesota

M. Usher, MD, PhD, Minnesota

M. Brinkmeier, MD, Missouri

S. Hassan, Missouri

R. Pitts, MD, Missouri

J. Sorg, MD, Missouri

M. Vaughan, Mississippi

C. Brown, ACMPE, North Carolina

D. Ghiassi, North Carolina

J. Hoffman, North Carolina

C. Norman, MS, PA-C, North Carolina

K. McDonald, MD, Nebraska

Y. Melnikova, MD, New Hampshire

J. Adigun, MD, New Jersey

S. Bhatt, MD, New Jersey

K. Bhavsar, New Jersey

S. Griggs, ANP, New York

G. Jabbour, New York

K. Kang, New York

P. Kayi, MD, New York

C. Lopez, MD, MPH, New York

O. Olafisoye, MD, New York

J. K. Salvani, MD, New York

M. Shinwa, New York

P. Wander, New York

S. Boyle, Ohio

S. Goates, Ohio

A. Hochhausler, MD, Ohio

V. Jayanti, Ohio

D. Kassay, CNP, Ohio

K. Welch, Ohio

J. Retson, CCFP, Ontario

V. Cheng, Pennsylvania

G. Chong, Pennsylvania

J. Hart, MD, Pennsylvania

M. M. Scoulos-Hanson, Pennsylvania

M. Shelkin, DO, Pennsylvania

S. Freeman, Rhode Island

G. Hussain, Rhode Island

R. Ulrich, PA-C, South Carolina

K. Inama, APRN-BC, South Dakota

S. Bray, Saskatchewan

D. E. Adams III, MD, Tennessee

I. Ellis, MD, Tennessee

C. Parrish, Tennessee

K. San, MC, USAR, Tennessee

A. Ahmed, MD, Texas

Z. Conrad, Texas

A. Iqbal, MD, Texas

J. Jamullamudi, MD, Texas

W. Mallot, Texas

C. Okoro, MD, Texas

C. Shy, Texas

P. Vankawala, Texas

L. Walker, Texas

D. Glodowski, MD, Utah

K. Brunson, NP, Virginia

E. Caldwell, Virginia

M. H. Chouindard, MD, Virginia

S. Edwards, MD, Virginia

S. Feldmann, Virginia

D. Kadariya, MBBS, MD, Virginia

J. Lachar, MBBS, MD, Virginia

B. Queen, MD, Virginia

A. M. Shamas, MD, Virginia

A. Wong, MD, Virginia

T. Chang, Washington

E. Gorbacheva, MD, Washington

Z. Li, PA-C, Washington

I. Murray, PA-C, Washington

M. Schaffer, MD, Washington

M. Stolzberg, Washington

K. Miller, MD, Wisconsin

C. Ranheim, MD, Wisconsin

A. Vincent, Wisconsin

J. Yi, DO, West Virginia

K. Han

S. Pannick

Y. Tan

Clinical question: In cardiopulmonary resuscitation, do continuous chest compressions improve survival or neurologic outcome compared to chest compressions interrupted for ventilation?

Background: Animal models have demonstrated that interruptions in chest compressions are associated with decreased survival and worse neurologic outcome in cardiac arrests. Observational studies in humans have suggested that for out-of-hospital cardiac arrests, continuous compressions result in improved survival.

Study Design: Unblinded, randomized, cluster design with crossover.

Setting: One hundred fourteen emergency medical service (EMS) agencies across eight clinical sites in North America.

Synopsis: Patients with out-of-hospital cardiac arrest received either continuous chest compressions with asynchronous positive-pressure ventilations or interrupted compressions at a rate of 30 compressions to two ventilations. EMS agencies were divided into clusters and randomly assigned to deliver either resuscitation strategy. Twice per year, each cluster switched treatment strategies.

During the active enrollment phase, 12,653 patients were enrolled in the intervention arm and 11,058 were enrolled in the control arm. The primary outcome of survival to hospital discharge was comparable between the two groups, with 9.0% survival rate in the intervention group as compared to 9.7% in the control group (P=0.07). The secondary outcome of survivorship with favorable neurologic status was similar at 7.0% in the intervention group and 7.7% in the control group.

There was only a small difference in the proportion of minutes devoted to compressions between the two groups, so the similarity in outcomes may be reflective of high-quality chest compressions. Additional limitations include a lack of standardization of post-resuscitation care and a lack of measurement of oxygen or ventilation delivered.

Bottom line: For out-of-hospital cardiac arrests, continuous chest compressions with positive-pressure ventilation did not increase survival or improve neurologic outcome compared to interrupted chest compressions.

Citation: Nichol G, Lerou B, Wang H, et al. Trial of continuous or interrupted chest compressions during CPR. N Engl J Med. 2015;373(23):2203-2214.

Clinical question: In cardiopulmonary resuscitation, do continuous chest compressions improve survival or neurologic outcome compared to chest compressions interrupted for ventilation?

Background: Animal models have demonstrated that interruptions in chest compressions are associated with decreased survival and worse neurologic outcome in cardiac arrests. Observational studies in humans have suggested that for out-of-hospital cardiac arrests, continuous compressions result in improved survival.

Study Design: Unblinded, randomized, cluster design with crossover.

Setting: One hundred fourteen emergency medical service (EMS) agencies across eight clinical sites in North America.

Synopsis: Patients with out-of-hospital cardiac arrest received either continuous chest compressions with asynchronous positive-pressure ventilations or interrupted compressions at a rate of 30 compressions to two ventilations. EMS agencies were divided into clusters and randomly assigned to deliver either resuscitation strategy. Twice per year, each cluster switched treatment strategies.

During the active enrollment phase, 12,653 patients were enrolled in the intervention arm and 11,058 were enrolled in the control arm. The primary outcome of survival to hospital discharge was comparable between the two groups, with 9.0% survival rate in the intervention group as compared to 9.7% in the control group (P=0.07). The secondary outcome of survivorship with favorable neurologic status was similar at 7.0% in the intervention group and 7.7% in the control group.

There was only a small difference in the proportion of minutes devoted to compressions between the two groups, so the similarity in outcomes may be reflective of high-quality chest compressions. Additional limitations include a lack of standardization of post-resuscitation care and a lack of measurement of oxygen or ventilation delivered.

Bottom line: For out-of-hospital cardiac arrests, continuous chest compressions with positive-pressure ventilation did not increase survival or improve neurologic outcome compared to interrupted chest compressions.

Citation: Nichol G, Lerou B, Wang H, et al. Trial of continuous or interrupted chest compressions during CPR. N Engl J Med. 2015;373(23):2203-2214.

Clinical question: In cardiopulmonary resuscitation, do continuous chest compressions improve survival or neurologic outcome compared to chest compressions interrupted for ventilation?

Background: Animal models have demonstrated that interruptions in chest compressions are associated with decreased survival and worse neurologic outcome in cardiac arrests. Observational studies in humans have suggested that for out-of-hospital cardiac arrests, continuous compressions result in improved survival.

Study Design: Unblinded, randomized, cluster design with crossover.

Setting: One hundred fourteen emergency medical service (EMS) agencies across eight clinical sites in North America.

Synopsis: Patients with out-of-hospital cardiac arrest received either continuous chest compressions with asynchronous positive-pressure ventilations or interrupted compressions at a rate of 30 compressions to two ventilations. EMS agencies were divided into clusters and randomly assigned to deliver either resuscitation strategy. Twice per year, each cluster switched treatment strategies.

During the active enrollment phase, 12,653 patients were enrolled in the intervention arm and 11,058 were enrolled in the control arm. The primary outcome of survival to hospital discharge was comparable between the two groups, with 9.0% survival rate in the intervention group as compared to 9.7% in the control group (P=0.07). The secondary outcome of survivorship with favorable neurologic status was similar at 7.0% in the intervention group and 7.7% in the control group.

There was only a small difference in the proportion of minutes devoted to compressions between the two groups, so the similarity in outcomes may be reflective of high-quality chest compressions. Additional limitations include a lack of standardization of post-resuscitation care and a lack of measurement of oxygen or ventilation delivered.

Bottom line: For out-of-hospital cardiac arrests, continuous chest compressions with positive-pressure ventilation did not increase survival or improve neurologic outcome compared to interrupted chest compressions.

Citation: Nichol G, Lerou B, Wang H, et al. Trial of continuous or interrupted chest compressions during CPR. N Engl J Med. 2015;373(23):2203-2214.

Clinical question: Does the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) risk score more accurately identify patients with atrial fibrillation (Afib) who are at low risk for ischemic stroke than the CHADS2 or CHA2DS2-VASc score?

Background: More accurate and reliable stroke risk prediction tools are needed to optimize anticoagulation decision making in patients with Afib. Recently, a new clinically based risk score, the ATRIA, has been developed and validated. This risk score assigns points based on four age categories (as well as an interaction of age and prior stroke); female gender; renal function; and history of diabetes, congestive heart failure, and hypertension. This study compared the predictive ability of the ATRIA risk score with the CHADS2 and CHA2DS2-VASc risk scores and their implications for anticoagulant treatment in Afib patients.

Study Design: Retrospective cohort study.

Setting: Afib patients not using warfarin from the United Kingdom’s Clinical Practice Research Datalink (CPRD) database, January 1998 to January 2012.

Synopsis: A total of 60,594 patients with Afib were followed until occurrence of ischemic stroke, prescription of warfarin, death, or the study’s end. The annualized stroke rate was 2.99%. Patients with moderate and high-risk CHA2DS2-VASc scores had lower event rates than those with corresponding ATRIA and CHADS2 scores. C-statistics for full point scores were 0.70 (95% CI, 0.69–0.71) for ATRIA and 0.68 (95% CI, 0.67–0.69) for both CHADS2 and CHA2DS2-VASc scores. The net reclassification index of ATRIA compared with CHADS2 and CHA2DS2-VASc risk scores were 0.137 and 0.233, respectively, reflecting that the ATRIA risk score better categorizes patients developing an event.

ATRIA risk score more accurately identified low-risk patients than the CHA2DS2-VASc score assigned to higher-risk categories. The results persisted even after restricting analysis to more recent follow-up, excluding unspecified strokes and excluding renal dysfunction as a predictor. Most improvements with ATRIA were the result of “down classification,” suggesting that using the CHA2DS2-VASc risk score could lead to overtreatment of patients at very low risk of stroke.

Bottom line: The ATRIA risk score better identifies Afib patients who are at low risk for stroke compared to CHADS2 and CHA2DS2-VASc scores.

Citation: van den Ham HA, Klungel OH, Singer DE, Leufkens HG, van Staa TP. Comparative performance of ATRIA, CHADS2, and CHA2DS2-VASc risk scores predicting stroke in patients with atrial fibrillation: results from a national primary care database. J Am Coll Cardiol. 2015;66(17):1851-1959.

Clinical question: Does the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) risk score more accurately identify patients with atrial fibrillation (Afib) who are at low risk for ischemic stroke than the CHADS2 or CHA2DS2-VASc score?

Background: More accurate and reliable stroke risk prediction tools are needed to optimize anticoagulation decision making in patients with Afib. Recently, a new clinically based risk score, the ATRIA, has been developed and validated. This risk score assigns points based on four age categories (as well as an interaction of age and prior stroke); female gender; renal function; and history of diabetes, congestive heart failure, and hypertension. This study compared the predictive ability of the ATRIA risk score with the CHADS2 and CHA2DS2-VASc risk scores and their implications for anticoagulant treatment in Afib patients.

Study Design: Retrospective cohort study.

Setting: Afib patients not using warfarin from the United Kingdom’s Clinical Practice Research Datalink (CPRD) database, January 1998 to January 2012.

Synopsis: A total of 60,594 patients with Afib were followed until occurrence of ischemic stroke, prescription of warfarin, death, or the study’s end. The annualized stroke rate was 2.99%. Patients with moderate and high-risk CHA2DS2-VASc scores had lower event rates than those with corresponding ATRIA and CHADS2 scores. C-statistics for full point scores were 0.70 (95% CI, 0.69–0.71) for ATRIA and 0.68 (95% CI, 0.67–0.69) for both CHADS2 and CHA2DS2-VASc scores. The net reclassification index of ATRIA compared with CHADS2 and CHA2DS2-VASc risk scores were 0.137 and 0.233, respectively, reflecting that the ATRIA risk score better categorizes patients developing an event.

ATRIA risk score more accurately identified low-risk patients than the CHA2DS2-VASc score assigned to higher-risk categories. The results persisted even after restricting analysis to more recent follow-up, excluding unspecified strokes and excluding renal dysfunction as a predictor. Most improvements with ATRIA were the result of “down classification,” suggesting that using the CHA2DS2-VASc risk score could lead to overtreatment of patients at very low risk of stroke.

Bottom line: The ATRIA risk score better identifies Afib patients who are at low risk for stroke compared to CHADS2 and CHA2DS2-VASc scores.

Citation: van den Ham HA, Klungel OH, Singer DE, Leufkens HG, van Staa TP. Comparative performance of ATRIA, CHADS2, and CHA2DS2-VASc risk scores predicting stroke in patients with atrial fibrillation: results from a national primary care database. J Am Coll Cardiol. 2015;66(17):1851-1959.

Clinical question: Does the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) risk score more accurately identify patients with atrial fibrillation (Afib) who are at low risk for ischemic stroke than the CHADS2 or CHA2DS2-VASc score?

Background: More accurate and reliable stroke risk prediction tools are needed to optimize anticoagulation decision making in patients with Afib. Recently, a new clinically based risk score, the ATRIA, has been developed and validated. This risk score assigns points based on four age categories (as well as an interaction of age and prior stroke); female gender; renal function; and history of diabetes, congestive heart failure, and hypertension. This study compared the predictive ability of the ATRIA risk score with the CHADS2 and CHA2DS2-VASc risk scores and their implications for anticoagulant treatment in Afib patients.

Study Design: Retrospective cohort study.

Setting: Afib patients not using warfarin from the United Kingdom’s Clinical Practice Research Datalink (CPRD) database, January 1998 to January 2012.

Synopsis: A total of 60,594 patients with Afib were followed until occurrence of ischemic stroke, prescription of warfarin, death, or the study’s end. The annualized stroke rate was 2.99%. Patients with moderate and high-risk CHA2DS2-VASc scores had lower event rates than those with corresponding ATRIA and CHADS2 scores. C-statistics for full point scores were 0.70 (95% CI, 0.69–0.71) for ATRIA and 0.68 (95% CI, 0.67–0.69) for both CHADS2 and CHA2DS2-VASc scores. The net reclassification index of ATRIA compared with CHADS2 and CHA2DS2-VASc risk scores were 0.137 and 0.233, respectively, reflecting that the ATRIA risk score better categorizes patients developing an event.

ATRIA risk score more accurately identified low-risk patients than the CHA2DS2-VASc score assigned to higher-risk categories. The results persisted even after restricting analysis to more recent follow-up, excluding unspecified strokes and excluding renal dysfunction as a predictor. Most improvements with ATRIA were the result of “down classification,” suggesting that using the CHA2DS2-VASc risk score could lead to overtreatment of patients at very low risk of stroke.

Bottom line: The ATRIA risk score better identifies Afib patients who are at low risk for stroke compared to CHADS2 and CHA2DS2-VASc scores.

Citation: van den Ham HA, Klungel OH, Singer DE, Leufkens HG, van Staa TP. Comparative performance of ATRIA, CHADS2, and CHA2DS2-VASc risk scores predicting stroke in patients with atrial fibrillation: results from a national primary care database. J Am Coll Cardiol. 2015;66(17):1851-1959.

The incident that perhaps most fully impressed the potential dangers of electronic health records (EHRs) on hospitalist pioneer Robert Wachter, MD, MHM, came two years ago. It started, innocently and well-intentioned enough, years earlier with the installation of EHR systems at the University of California at San Francisco (UCSF). Flash-forward to 2013 and a 16-year-old boy’s admission to UCSF’s Benioff Children’s Hospital for a routine colonoscopy related to his NEMO deficiency syndrome, a rare genetic disease that affects the bowels. For his nightly medications that evening, the boy was supposed to take a single dose of Septra, a common antibiotic that hospitalists and internists across the nation routinely prescribe for urinary and skin infections.

But this boy took 38.5 doses, one pill at a time.

How could that possibly happen? Hospitalists might rightly ask.

Because the EHR told everyone involved that’s what the dose should be. So every physician, pharmacist, and nurse involved in the boy’s treatment carried out the order to a T, discovering the error only when the teenager later complained of anxiety, mild confusion, and tingling so acute he felt “numb all over.”

In an era when EHR is king, an adverse event such as a 39-fold overdose is just another example of the unintended consequences technology has foisted upon hospitalists and other providers in America’s massive healthcare system. It is the unfortunate underbelly of healthcare’s rapid-fire introduction to EHR, thanks to a flood of federal funding over the past 10 years, Dr. Wachter says.

“Most fields that go digital do so over the course of 10 or 20 years in a very organic way, with the early adopters, the rank and file, and then the laggards,” Dr. Wachter said at SHM’s 2015 annual meeting in Washington, D.C., where he recounted the UCSF overdose in a keynote address. “In that kind of organic adoption curve, you see problems arise, and people begin to deal with them and understand them and mitigate them. What the federal intervention did was essentially turbocharge the digitization of healthcare.”

And with the relative speed of digitization comes unintended consequences, including:

• Unfriendly user interfaces that stymie and frustrate physicians accustomed to comparatively intuitive smartphones and tablets;
• Limited applicability of EHRs to quality improvement (QI) projects, as the systems are, in essence, first constructed as billing and coding constructs;
• Alert fatigue tied to EHRs and such medical devices as ventilators, blood pressure monitors, and electrocardiograms desensitize physicians to true concerns; and
• The “cut-and-paste” phenomenon of transferring daily notes or other orders that’s only growing as EHRs become more ubiquitous (see “CTRL-C + CTRL-V = DANGER”).

“Health IT [HIT] is not the panacea that many have touted it as, and it’s really a question of a reassessment of where exactly we are right now compared with where we thought we would be,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “I think our endpoint—that we’re going to get to—this is all going to result in better care. But we’re in that middle period of extreme danger right now where we could actually be doing harm to our patients but certainly are frustrating our providers.”

Funding Failure?

HIT’s rapid evolution starts with the creation of the Office of the National Coordinator for Health Information Technology (ONC) in 2004, which began receiving funding in 2009 to the tune of $30 billion to improve health information exchanges between physicians and institutions.

The money “spent in adoption should have been spent in innovation and development and research to show what works and what doesn’t well before you started pushing adoption,” Dr. Rogers says. “But at this stage, we can’t go backward … the plan is in flight, and we have to try to repair it in the air at this point.”

To that end, The Joint Commission in March 2015 issued a Sentinel Event Alert to highlight that the safest use of HIT still needs structural improvement. The Joint Commission analyzed 120 sentinel events (which it defines as unexpected occurrences involving death or serious physical or psychological injury or the risk thereof) that were HIT-related between Jan. 1, 2010, and June 30, 2013. Eighty percent were issues with human-computer interface, workflow and communication, or design or data issues tied to clinical content or decision support.

“As health IT adoption spreads and becomes a critical component of organizational infrastructure, the potential for health IT-related harm will likely increase unless risk-reducing measures are put into place,” the alert stated.

To that end, The Joint Commission recommends:

1. Focusing on creating and maintaining a safety culture;
2. Developing a proactive approach to process improvement that includes assessing patient safety risk; and
3. Enlisting physicians and administrators from multiple disciplines to oversee HIT planning, implementation, and evaluation.

Terry Edwards, chief executive officer of PerfectServe, a Knoxville, Tenn., firm that works on healthcare communications systems, says that a survey his firm conducted in 2015 found that, among clinicians needing to communicate with an in-house colleague about “complex or in-depth information,” an EHR is used 12% of the time. Just 8% of hospitalists surveyed used it. The rest used workarounds, face-to-face conversations, and myriad customized solutions to communicate.

“Workarounds happen all the time in healthcare because many of the tools and technologies impede rather than enhance a clinician’s efficiency,” Edwards says in an email to The Hospitalist. “It’s pretty clear that many physicians are frustrated by EHR technology.”

Backwards Revolution

The natural question around unintended consequences: Why didn’t physicians or others see them coming as EHRs and HIT were burgeoning the past decade? Dr. Rogers says that hospitalists and physicians weren’t involved enough on the front-end design of EHRs.

So instead of systems that have been built to be intuitive to the real-time workflow of hospitalists, nurse practitioners, and physician assistants, the systems are built more for back-office administrative functions, he adds.

“When we have programmers and non-clinical people trying to build products for us, they’re dictating our workflow,” Dr. Rogers says. “In many cases, they don’t understand our workflow, and in many more cases, our workflow differs from the last person or the last hospital they worked at.

“This is where we get into issues around usability.”

Take the overdose patient at UCSF. One wrong number typed into a single field led to the oversize dosage. Safety redundancies built in the system flagged the excessive dosage each time, but at each point, a human decided to keep the dosage at the incorrect size because, essentially, everyone trusted the EHR.

All of those red flags come with their own unintended consequence: alert fatigue.

“When people really get fatigued with all of these alerts, they start to ignore them,” says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. “So now here comes the question: How do we properly set the limit or threshold?”

In the airline industry, alerts are often tiered to give pilots an immediate sense of their importance. But Dr. Kao says the typical EHR interface is not that advanced, an often frustrating trait to younger physicians accustomed to user-friendly iPhones and web applications. The same frustration often is found with the litany of medical devices hospitalists interact with each day.

“Everything is a fundamental question: How do we set up an optimal environment for humans to interact with computers?” Dr. Kao adds. “We are talking about usability. We are talking about optimizing the IT system that blends into people’s daily workflow so they don’t feel disrupted and have to develop a workaround.”

Solutions Wanted

One EHR critic suggests that the proliferation of workarounds could be solved by a moratorium on further implementation and rollout of EHR systems.

“During that moratorium, there needs to be a complete rethinking of roles, i.e., who does what with these systems, and what needs to be severely rethought are the roles of who gets to do what, including data entry,” says Scot Silverstein, a health IT consultant in Philadelphia. “There’s just no way you can make entry of information into complex computer systems rapid with multiple computer screens that have to be navigated through ad infinitum. There’s just no way you can make that anywhere near as efficient, and you can’t make it less distracting and untiring compared to paper.

“I’m advocating not a return to paper but a consideration of where a paper intermediary—such as specialized forms—between clinicians and information system are appropriate.”

Silverstein says that the relatively rushed overlay of computer systems on medicine meant that corporate computing models were simply pushed into healthcare, a world that operates very differently than most other industries. He says that is why adverse events will continue to occur; why The Joint Commission felt the need to issue an alert; and why the ECRI Institute, a quasi-Consumer Reports organization for healthcare, listed “data integrity failures with health information technology systems” atop its Top 10 Patient Safety Concerns for 2014. Other EHR concerns have been on the list the past several years as well.

“The business computing model, which dates back to the days of card-punch tabulators that IBM developed in the 1920s and ’30s, really has a completely wrong model of medicine,” Silverstein adds. “Medicine is not a predictable, controlled, regular environment. It is an environment of emergencies, irregular events, unpredictability, poor boundaries. Every possible thing in the world can and does go wrong.”

Dr. Rogers agrees that HIT is not optimal, but he sees little point in a moratorium or trying to stop whatever positive progress has already occurred.

“The train has left,” he says. The best approach now is twofold.

First, Dr. Rogers urges hospitalists to formalize their HIT duties by seeing if they would qualify to take the exam for board certification in medical informatics, which was created in 2013 by the American Board of Medical Specialties (ABMS). The more hospitalists who are recognized for the work they already do with EHRs, the more they can then use their positions to help lobby their institutions for changes.

Second, Dr. Rogers wants hospitalists to work as much as possible with vendors, other clinical informaticians, and related stakeholders to help improve the existing system as much as possible. In particular, improvements could help EHRs integrate clinical decision support better, which could then serve as the foundation for research and quality improvement.

Dr. Rogers uses VTE prophylaxis as an example. Before digitalization, “we were able to build all those flow diagrams onto a sheet of paper that would have logical branching points.” Now, pull-down menus and long, one-dimensional order sets regiment what can be input, and medical logic is not the primary concern.

Often, EHR providers will say issues are tied to a lack of training.

“When a vendor repeatedly says this is a training issue, I guarantee that there is a design issue that can be improved,” Dr. Rogers says.

Instead, he and others urge third-party vendors be allowed to design programs and software that can help. He likens it to independent application developers building programs for iPhones and Androids, as opposed to firms like Apple saying that only their internally developed applications would be used.

“Apple would be nowhere right now” had they done that, Dr. Rogers says. “What made them successful was creating a marketplace that all of these individuals out there—thousands of people—could start designing innovations and applications that would fit what that population needed, no matter how small that population was.”

He says a single system, applicable across all healthcare settings, would make an “even playing field for third-party vendors.”

“I think we could get there much faster,” he says. “Within a five-year period of time, I think we could solve a lot of these issues that we’re having right now.” TH

Richard Quinn is a freelance writer in New Jersey.

CTRL-C + CTRL-V = DANGER

Cut-and-paste is as basic a technique as there is in word processing. But with electronic health records (EHRs), that simple maneuver is becoming a danger as repetitive orders, outdated diagnoses, and other inaccurate information is just moved forward unwittingly.

“It’s almost ubiquitous in many cases,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “Certainly, almost every note that I see in our EHR has some portion of cut-and-paste in it.”

The phenomenon is one borne of a simple workaround. Much of the daily note input on an admitted patient’s screen is repetitive and time-consuming, says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. So it might seem to make sense to reuse yesterday’s note today.

But if the note called for a test or a treatment, mistakes can happen.

“We are trying to create new note templates that allow extracting discrete data for billing and research purposes,” Dr. Kao says. “We don’t allow [users] to copy easily, but we do try to make it much easier for them to write a note. So they wouldn’t be copying exactly the same notes from yesterday, but in the meantime, they are able to put in some meaningful information each day.”

Put more simply: “When the right things are made easier to do, people tend to do the right thing. And that is our goal.”

Dr. Rogers suggests keeping the dangers of cut-and-paste errors front of mind and, similar to other EHR documentation issues, lobbying for improvements to the system itself.

“Copy-and-paste is our workaround for poorly designed documentation systems,” he adds. “That does not make it right to use it, but the way to eradicate it is to build better systems that allow documentation to become a part of providing care.”

—Richard Quinn

The incident that perhaps most fully impressed the potential dangers of electronic health records (EHRs) on hospitalist pioneer Robert Wachter, MD, MHM, came two years ago. It started, innocently and well-intentioned enough, years earlier with the installation of EHR systems at the University of California at San Francisco (UCSF). Flash-forward to 2013 and a 16-year-old boy’s admission to UCSF’s Benioff Children’s Hospital for a routine colonoscopy related to his NEMO deficiency syndrome, a rare genetic disease that affects the bowels. For his nightly medications that evening, the boy was supposed to take a single dose of Septra, a common antibiotic that hospitalists and internists across the nation routinely prescribe for urinary and skin infections.

But this boy took 38.5 doses, one pill at a time.

How could that possibly happen? Hospitalists might rightly ask.

Because the EHR told everyone involved that’s what the dose should be. So every physician, pharmacist, and nurse involved in the boy’s treatment carried out the order to a T, discovering the error only when the teenager later complained of anxiety, mild confusion, and tingling so acute he felt “numb all over.”

In an era when EHR is king, an adverse event such as a 39-fold overdose is just another example of the unintended consequences technology has foisted upon hospitalists and other providers in America’s massive healthcare system. It is the unfortunate underbelly of healthcare’s rapid-fire introduction to EHR, thanks to a flood of federal funding over the past 10 years, Dr. Wachter says.

“Most fields that go digital do so over the course of 10 or 20 years in a very organic way, with the early adopters, the rank and file, and then the laggards,” Dr. Wachter said at SHM’s 2015 annual meeting in Washington, D.C., where he recounted the UCSF overdose in a keynote address. “In that kind of organic adoption curve, you see problems arise, and people begin to deal with them and understand them and mitigate them. What the federal intervention did was essentially turbocharge the digitization of healthcare.”

And with the relative speed of digitization comes unintended consequences, including:

• Unfriendly user interfaces that stymie and frustrate physicians accustomed to comparatively intuitive smartphones and tablets;
• Limited applicability of EHRs to quality improvement (QI) projects, as the systems are, in essence, first constructed as billing and coding constructs;
• Alert fatigue tied to EHRs and such medical devices as ventilators, blood pressure monitors, and electrocardiograms desensitize physicians to true concerns; and
• The “cut-and-paste” phenomenon of transferring daily notes or other orders that’s only growing as EHRs become more ubiquitous (see “CTRL-C + CTRL-V = DANGER”).

“Health IT [HIT] is not the panacea that many have touted it as, and it’s really a question of a reassessment of where exactly we are right now compared with where we thought we would be,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “I think our endpoint—that we’re going to get to—this is all going to result in better care. But we’re in that middle period of extreme danger right now where we could actually be doing harm to our patients but certainly are frustrating our providers.”

Funding Failure?

HIT’s rapid evolution starts with the creation of the Office of the National Coordinator for Health Information Technology (ONC) in 2004, which began receiving funding in 2009 to the tune of $30 billion to improve health information exchanges between physicians and institutions.

The money “spent in adoption should have been spent in innovation and development and research to show what works and what doesn’t well before you started pushing adoption,” Dr. Rogers says. “But at this stage, we can’t go backward … the plan is in flight, and we have to try to repair it in the air at this point.”

To that end, The Joint Commission in March 2015 issued a Sentinel Event Alert to highlight that the safest use of HIT still needs structural improvement. The Joint Commission analyzed 120 sentinel events (which it defines as unexpected occurrences involving death or serious physical or psychological injury or the risk thereof) that were HIT-related between Jan. 1, 2010, and June 30, 2013. Eighty percent were issues with human-computer interface, workflow and communication, or design or data issues tied to clinical content or decision support.

“As health IT adoption spreads and becomes a critical component of organizational infrastructure, the potential for health IT-related harm will likely increase unless risk-reducing measures are put into place,” the alert stated.

To that end, The Joint Commission recommends:

1. Focusing on creating and maintaining a safety culture;
2. Developing a proactive approach to process improvement that includes assessing patient safety risk; and
3. Enlisting physicians and administrators from multiple disciplines to oversee HIT planning, implementation, and evaluation.

Terry Edwards, chief executive officer of PerfectServe, a Knoxville, Tenn., firm that works on healthcare communications systems, says that a survey his firm conducted in 2015 found that, among clinicians needing to communicate with an in-house colleague about “complex or in-depth information,” an EHR is used 12% of the time. Just 8% of hospitalists surveyed used it. The rest used workarounds, face-to-face conversations, and myriad customized solutions to communicate.

“Workarounds happen all the time in healthcare because many of the tools and technologies impede rather than enhance a clinician’s efficiency,” Edwards says in an email to The Hospitalist. “It’s pretty clear that many physicians are frustrated by EHR technology.”

Backwards Revolution

The natural question around unintended consequences: Why didn’t physicians or others see them coming as EHRs and HIT were burgeoning the past decade? Dr. Rogers says that hospitalists and physicians weren’t involved enough on the front-end design of EHRs.

So instead of systems that have been built to be intuitive to the real-time workflow of hospitalists, nurse practitioners, and physician assistants, the systems are built more for back-office administrative functions, he adds.

“When we have programmers and non-clinical people trying to build products for us, they’re dictating our workflow,” Dr. Rogers says. “In many cases, they don’t understand our workflow, and in many more cases, our workflow differs from the last person or the last hospital they worked at.

“This is where we get into issues around usability.”

Take the overdose patient at UCSF. One wrong number typed into a single field led to the oversize dosage. Safety redundancies built in the system flagged the excessive dosage each time, but at each point, a human decided to keep the dosage at the incorrect size because, essentially, everyone trusted the EHR.

All of those red flags come with their own unintended consequence: alert fatigue.

“When people really get fatigued with all of these alerts, they start to ignore them,” says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. “So now here comes the question: How do we properly set the limit or threshold?”

In the airline industry, alerts are often tiered to give pilots an immediate sense of their importance. But Dr. Kao says the typical EHR interface is not that advanced, an often frustrating trait to younger physicians accustomed to user-friendly iPhones and web applications. The same frustration often is found with the litany of medical devices hospitalists interact with each day.

“Everything is a fundamental question: How do we set up an optimal environment for humans to interact with computers?” Dr. Kao adds. “We are talking about usability. We are talking about optimizing the IT system that blends into people’s daily workflow so they don’t feel disrupted and have to develop a workaround.”

Solutions Wanted

One EHR critic suggests that the proliferation of workarounds could be solved by a moratorium on further implementation and rollout of EHR systems.

“During that moratorium, there needs to be a complete rethinking of roles, i.e., who does what with these systems, and what needs to be severely rethought are the roles of who gets to do what, including data entry,” says Scot Silverstein, a health IT consultant in Philadelphia. “There’s just no way you can make entry of information into complex computer systems rapid with multiple computer screens that have to be navigated through ad infinitum. There’s just no way you can make that anywhere near as efficient, and you can’t make it less distracting and untiring compared to paper.

“I’m advocating not a return to paper but a consideration of where a paper intermediary—such as specialized forms—between clinicians and information system are appropriate.”

Silverstein says that the relatively rushed overlay of computer systems on medicine meant that corporate computing models were simply pushed into healthcare, a world that operates very differently than most other industries. He says that is why adverse events will continue to occur; why The Joint Commission felt the need to issue an alert; and why the ECRI Institute, a quasi-Consumer Reports organization for healthcare, listed “data integrity failures with health information technology systems” atop its Top 10 Patient Safety Concerns for 2014. Other EHR concerns have been on the list the past several years as well.

“The business computing model, which dates back to the days of card-punch tabulators that IBM developed in the 1920s and ’30s, really has a completely wrong model of medicine,” Silverstein adds. “Medicine is not a predictable, controlled, regular environment. It is an environment of emergencies, irregular events, unpredictability, poor boundaries. Every possible thing in the world can and does go wrong.”

Dr. Rogers agrees that HIT is not optimal, but he sees little point in a moratorium or trying to stop whatever positive progress has already occurred.

“The train has left,” he says. The best approach now is twofold.

First, Dr. Rogers urges hospitalists to formalize their HIT duties by seeing if they would qualify to take the exam for board certification in medical informatics, which was created in 2013 by the American Board of Medical Specialties (ABMS). The more hospitalists who are recognized for the work they already do with EHRs, the more they can then use their positions to help lobby their institutions for changes.

Second, Dr. Rogers wants hospitalists to work as much as possible with vendors, other clinical informaticians, and related stakeholders to help improve the existing system as much as possible. In particular, improvements could help EHRs integrate clinical decision support better, which could then serve as the foundation for research and quality improvement.

Dr. Rogers uses VTE prophylaxis as an example. Before digitalization, “we were able to build all those flow diagrams onto a sheet of paper that would have logical branching points.” Now, pull-down menus and long, one-dimensional order sets regiment what can be input, and medical logic is not the primary concern.

Often, EHR providers will say issues are tied to a lack of training.

“When a vendor repeatedly says this is a training issue, I guarantee that there is a design issue that can be improved,” Dr. Rogers says.

Instead, he and others urge third-party vendors be allowed to design programs and software that can help. He likens it to independent application developers building programs for iPhones and Androids, as opposed to firms like Apple saying that only their internally developed applications would be used.

“Apple would be nowhere right now” had they done that, Dr. Rogers says. “What made them successful was creating a marketplace that all of these individuals out there—thousands of people—could start designing innovations and applications that would fit what that population needed, no matter how small that population was.”

He says a single system, applicable across all healthcare settings, would make an “even playing field for third-party vendors.”

“I think we could get there much faster,” he says. “Within a five-year period of time, I think we could solve a lot of these issues that we’re having right now.” TH

Richard Quinn is a freelance writer in New Jersey.

CTRL-C + CTRL-V = DANGER

Cut-and-paste is as basic a technique as there is in word processing. But with electronic health records (EHRs), that simple maneuver is becoming a danger as repetitive orders, outdated diagnoses, and other inaccurate information is just moved forward unwittingly.

“It’s almost ubiquitous in many cases,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “Certainly, almost every note that I see in our EHR has some portion of cut-and-paste in it.”

The phenomenon is one borne of a simple workaround. Much of the daily note input on an admitted patient’s screen is repetitive and time-consuming, says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. So it might seem to make sense to reuse yesterday’s note today.

But if the note called for a test or a treatment, mistakes can happen.

“We are trying to create new note templates that allow extracting discrete data for billing and research purposes,” Dr. Kao says. “We don’t allow [users] to copy easily, but we do try to make it much easier for them to write a note. So they wouldn’t be copying exactly the same notes from yesterday, but in the meantime, they are able to put in some meaningful information each day.”

Put more simply: “When the right things are made easier to do, people tend to do the right thing. And that is our goal.”

Dr. Rogers suggests keeping the dangers of cut-and-paste errors front of mind and, similar to other EHR documentation issues, lobbying for improvements to the system itself.

“Copy-and-paste is our workaround for poorly designed documentation systems,” he adds. “That does not make it right to use it, but the way to eradicate it is to build better systems that allow documentation to become a part of providing care.”

—Richard Quinn

The incident that perhaps most fully impressed the potential dangers of electronic health records (EHRs) on hospitalist pioneer Robert Wachter, MD, MHM, came two years ago. It started, innocently and well-intentioned enough, years earlier with the installation of EHR systems at the University of California at San Francisco (UCSF). Flash-forward to 2013 and a 16-year-old boy’s admission to UCSF’s Benioff Children’s Hospital for a routine colonoscopy related to his NEMO deficiency syndrome, a rare genetic disease that affects the bowels. For his nightly medications that evening, the boy was supposed to take a single dose of Septra, a common antibiotic that hospitalists and internists across the nation routinely prescribe for urinary and skin infections.

But this boy took 38.5 doses, one pill at a time.

How could that possibly happen? Hospitalists might rightly ask.

Because the EHR told everyone involved that’s what the dose should be. So every physician, pharmacist, and nurse involved in the boy’s treatment carried out the order to a T, discovering the error only when the teenager later complained of anxiety, mild confusion, and tingling so acute he felt “numb all over.”

In an era when EHR is king, an adverse event such as a 39-fold overdose is just another example of the unintended consequences technology has foisted upon hospitalists and other providers in America’s massive healthcare system. It is the unfortunate underbelly of healthcare’s rapid-fire introduction to EHR, thanks to a flood of federal funding over the past 10 years, Dr. Wachter says.

“Most fields that go digital do so over the course of 10 or 20 years in a very organic way, with the early adopters, the rank and file, and then the laggards,” Dr. Wachter said at SHM’s 2015 annual meeting in Washington, D.C., where he recounted the UCSF overdose in a keynote address. “In that kind of organic adoption curve, you see problems arise, and people begin to deal with them and understand them and mitigate them. What the federal intervention did was essentially turbocharge the digitization of healthcare.”

And with the relative speed of digitization comes unintended consequences, including:

• Unfriendly user interfaces that stymie and frustrate physicians accustomed to comparatively intuitive smartphones and tablets;
• Limited applicability of EHRs to quality improvement (QI) projects, as the systems are, in essence, first constructed as billing and coding constructs;
• Alert fatigue tied to EHRs and such medical devices as ventilators, blood pressure monitors, and electrocardiograms desensitize physicians to true concerns; and
• The “cut-and-paste” phenomenon of transferring daily notes or other orders that’s only growing as EHRs become more ubiquitous (see “CTRL-C + CTRL-V = DANGER”).

“Health IT [HIT] is not the panacea that many have touted it as, and it’s really a question of a reassessment of where exactly we are right now compared with where we thought we would be,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “I think our endpoint—that we’re going to get to—this is all going to result in better care. But we’re in that middle period of extreme danger right now where we could actually be doing harm to our patients but certainly are frustrating our providers.”

Funding Failure?

HIT’s rapid evolution starts with the creation of the Office of the National Coordinator for Health Information Technology (ONC) in 2004, which began receiving funding in 2009 to the tune of $30 billion to improve health information exchanges between physicians and institutions.

The money “spent in adoption should have been spent in innovation and development and research to show what works and what doesn’t well before you started pushing adoption,” Dr. Rogers says. “But at this stage, we can’t go backward … the plan is in flight, and we have to try to repair it in the air at this point.”

To that end, The Joint Commission in March 2015 issued a Sentinel Event Alert to highlight that the safest use of HIT still needs structural improvement. The Joint Commission analyzed 120 sentinel events (which it defines as unexpected occurrences involving death or serious physical or psychological injury or the risk thereof) that were HIT-related between Jan. 1, 2010, and June 30, 2013. Eighty percent were issues with human-computer interface, workflow and communication, or design or data issues tied to clinical content or decision support.

“As health IT adoption spreads and becomes a critical component of organizational infrastructure, the potential for health IT-related harm will likely increase unless risk-reducing measures are put into place,” the alert stated.

To that end, The Joint Commission recommends:

1. Focusing on creating and maintaining a safety culture;
2. Developing a proactive approach to process improvement that includes assessing patient safety risk; and
3. Enlisting physicians and administrators from multiple disciplines to oversee HIT planning, implementation, and evaluation.

Terry Edwards, chief executive officer of PerfectServe, a Knoxville, Tenn., firm that works on healthcare communications systems, says that a survey his firm conducted in 2015 found that, among clinicians needing to communicate with an in-house colleague about “complex or in-depth information,” an EHR is used 12% of the time. Just 8% of hospitalists surveyed used it. The rest used workarounds, face-to-face conversations, and myriad customized solutions to communicate.

“Workarounds happen all the time in healthcare because many of the tools and technologies impede rather than enhance a clinician’s efficiency,” Edwards says in an email to The Hospitalist. “It’s pretty clear that many physicians are frustrated by EHR technology.”

Backwards Revolution

The natural question around unintended consequences: Why didn’t physicians or others see them coming as EHRs and HIT were burgeoning the past decade? Dr. Rogers says that hospitalists and physicians weren’t involved enough on the front-end design of EHRs.

So instead of systems that have been built to be intuitive to the real-time workflow of hospitalists, nurse practitioners, and physician assistants, the systems are built more for back-office administrative functions, he adds.

“When we have programmers and non-clinical people trying to build products for us, they’re dictating our workflow,” Dr. Rogers says. “In many cases, they don’t understand our workflow, and in many more cases, our workflow differs from the last person or the last hospital they worked at.

“This is where we get into issues around usability.”

Take the overdose patient at UCSF. One wrong number typed into a single field led to the oversize dosage. Safety redundancies built in the system flagged the excessive dosage each time, but at each point, a human decided to keep the dosage at the incorrect size because, essentially, everyone trusted the EHR.

All of those red flags come with their own unintended consequence: alert fatigue.

“When people really get fatigued with all of these alerts, they start to ignore them,” says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. “So now here comes the question: How do we properly set the limit or threshold?”

In the airline industry, alerts are often tiered to give pilots an immediate sense of their importance. But Dr. Kao says the typical EHR interface is not that advanced, an often frustrating trait to younger physicians accustomed to user-friendly iPhones and web applications. The same frustration often is found with the litany of medical devices hospitalists interact with each day.

“Everything is a fundamental question: How do we set up an optimal environment for humans to interact with computers?” Dr. Kao adds. “We are talking about usability. We are talking about optimizing the IT system that blends into people’s daily workflow so they don’t feel disrupted and have to develop a workaround.”

Solutions Wanted

One EHR critic suggests that the proliferation of workarounds could be solved by a moratorium on further implementation and rollout of EHR systems.

“During that moratorium, there needs to be a complete rethinking of roles, i.e., who does what with these systems, and what needs to be severely rethought are the roles of who gets to do what, including data entry,” says Scot Silverstein, a health IT consultant in Philadelphia. “There’s just no way you can make entry of information into complex computer systems rapid with multiple computer screens that have to be navigated through ad infinitum. There’s just no way you can make that anywhere near as efficient, and you can’t make it less distracting and untiring compared to paper.

“I’m advocating not a return to paper but a consideration of where a paper intermediary—such as specialized forms—between clinicians and information system are appropriate.”

Silverstein says that the relatively rushed overlay of computer systems on medicine meant that corporate computing models were simply pushed into healthcare, a world that operates very differently than most other industries. He says that is why adverse events will continue to occur; why The Joint Commission felt the need to issue an alert; and why the ECRI Institute, a quasi-Consumer Reports organization for healthcare, listed “data integrity failures with health information technology systems” atop its Top 10 Patient Safety Concerns for 2014. Other EHR concerns have been on the list the past several years as well.

“The business computing model, which dates back to the days of card-punch tabulators that IBM developed in the 1920s and ’30s, really has a completely wrong model of medicine,” Silverstein adds. “Medicine is not a predictable, controlled, regular environment. It is an environment of emergencies, irregular events, unpredictability, poor boundaries. Every possible thing in the world can and does go wrong.”

Dr. Rogers agrees that HIT is not optimal, but he sees little point in a moratorium or trying to stop whatever positive progress has already occurred.

“The train has left,” he says. The best approach now is twofold.

First, Dr. Rogers urges hospitalists to formalize their HIT duties by seeing if they would qualify to take the exam for board certification in medical informatics, which was created in 2013 by the American Board of Medical Specialties (ABMS). The more hospitalists who are recognized for the work they already do with EHRs, the more they can then use their positions to help lobby their institutions for changes.

Second, Dr. Rogers wants hospitalists to work as much as possible with vendors, other clinical informaticians, and related stakeholders to help improve the existing system as much as possible. In particular, improvements could help EHRs integrate clinical decision support better, which could then serve as the foundation for research and quality improvement.

Dr. Rogers uses VTE prophylaxis as an example. Before digitalization, “we were able to build all those flow diagrams onto a sheet of paper that would have logical branching points.” Now, pull-down menus and long, one-dimensional order sets regiment what can be input, and medical logic is not the primary concern.

Often, EHR providers will say issues are tied to a lack of training.

“When a vendor repeatedly says this is a training issue, I guarantee that there is a design issue that can be improved,” Dr. Rogers says.

Instead, he and others urge third-party vendors be allowed to design programs and software that can help. He likens it to independent application developers building programs for iPhones and Androids, as opposed to firms like Apple saying that only their internally developed applications would be used.

“Apple would be nowhere right now” had they done that, Dr. Rogers says. “What made them successful was creating a marketplace that all of these individuals out there—thousands of people—could start designing innovations and applications that would fit what that population needed, no matter how small that population was.”

He says a single system, applicable across all healthcare settings, would make an “even playing field for third-party vendors.”

“I think we could get there much faster,” he says. “Within a five-year period of time, I think we could solve a lot of these issues that we’re having right now.” TH

Richard Quinn is a freelance writer in New Jersey.

CTRL-C + CTRL-V = DANGER

Cut-and-paste is as basic a technique as there is in word processing. But with electronic health records (EHRs), that simple maneuver is becoming a danger as repetitive orders, outdated diagnoses, and other inaccurate information is just moved forward unwittingly.

“It’s almost ubiquitous in many cases,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “Certainly, almost every note that I see in our EHR has some portion of cut-and-paste in it.”

The phenomenon is one borne of a simple workaround. Much of the daily note input on an admitted patient’s screen is repetitive and time-consuming, says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. So it might seem to make sense to reuse yesterday’s note today.

But if the note called for a test or a treatment, mistakes can happen.

“We are trying to create new note templates that allow extracting discrete data for billing and research purposes,” Dr. Kao says. “We don’t allow [users] to copy easily, but we do try to make it much easier for them to write a note. So they wouldn’t be copying exactly the same notes from yesterday, but in the meantime, they are able to put in some meaningful information each day.”

Put more simply: “When the right things are made easier to do, people tend to do the right thing. And that is our goal.”

Dr. Rogers suggests keeping the dangers of cut-and-paste errors front of mind and, similar to other EHR documentation issues, lobbying for improvements to the system itself.

“Copy-and-paste is our workaround for poorly designed documentation systems,” he adds. “That does not make it right to use it, but the way to eradicate it is to build better systems that allow documentation to become a part of providing care.”

—Richard Quinn

SHM’s implementation tool kits provide hospitalists the information and tools they need to lead quality improvement projects on specific clinical topics, including two recent releases focused on anemia and congestive heart failure.

One third of the world’s population suffers from anemia, and SHM’s Center for Hospital Innovation and Improvement recently released a tool kit to improve outcomes by providing a framework for hospital-based anemia management quality improvement projects. It reviews each step of the process from forming a multidisciplinary team, obtaining institutional support, assessing baseline performance, and defining key metrics to implementing changes and monitoring their effects, with a focus on blood transfusion best practices.

Such projects can be expected to improve patient outcomes, improve the utilization of scarce resources such as allogeneic blood, and decrease transfusion-related adverse events, enabling hospitals to provide a better quality of care at a lower cost. In today’s competitive healthcare environment, these are quality gains and cost savings that hospitals cannot afford to miss.

Another recent release from the center, the congestive heart failure implementation guide, reviews methods to optimize heart failure care during and after hospital admission episodes. Congestive heart failure is responsible for 11 million physician visits annually and more hospitalizations than all forms of cancer combined.

Other recently added tool kits cover COPD, glycemic control, opioid monitoring, delirium, and pain management.

For more information on these tool kits and how the Center for Hospital Innovation and Improvement can share its proven best practices with your hospital, visit www.hospitalmedicine.org/CenterTJ16.

SHM’s implementation tool kits provide hospitalists the information and tools they need to lead quality improvement projects on specific clinical topics, including two recent releases focused on anemia and congestive heart failure.

One third of the world’s population suffers from anemia, and SHM’s Center for Hospital Innovation and Improvement recently released a tool kit to improve outcomes by providing a framework for hospital-based anemia management quality improvement projects. It reviews each step of the process from forming a multidisciplinary team, obtaining institutional support, assessing baseline performance, and defining key metrics to implementing changes and monitoring their effects, with a focus on blood transfusion best practices.

Such projects can be expected to improve patient outcomes, improve the utilization of scarce resources such as allogeneic blood, and decrease transfusion-related adverse events, enabling hospitals to provide a better quality of care at a lower cost. In today’s competitive healthcare environment, these are quality gains and cost savings that hospitals cannot afford to miss.

Another recent release from the center, the congestive heart failure implementation guide, reviews methods to optimize heart failure care during and after hospital admission episodes. Congestive heart failure is responsible for 11 million physician visits annually and more hospitalizations than all forms of cancer combined.

Other recently added tool kits cover COPD, glycemic control, opioid monitoring, delirium, and pain management.

For more information on these tool kits and how the Center for Hospital Innovation and Improvement can share its proven best practices with your hospital, visit www.hospitalmedicine.org/CenterTJ16.

SHM’s implementation tool kits provide hospitalists the information and tools they need to lead quality improvement projects on specific clinical topics, including two recent releases focused on anemia and congestive heart failure.

One third of the world’s population suffers from anemia, and SHM’s Center for Hospital Innovation and Improvement recently released a tool kit to improve outcomes by providing a framework for hospital-based anemia management quality improvement projects. It reviews each step of the process from forming a multidisciplinary team, obtaining institutional support, assessing baseline performance, and defining key metrics to implementing changes and monitoring their effects, with a focus on blood transfusion best practices.

Such projects can be expected to improve patient outcomes, improve the utilization of scarce resources such as allogeneic blood, and decrease transfusion-related adverse events, enabling hospitals to provide a better quality of care at a lower cost. In today’s competitive healthcare environment, these are quality gains and cost savings that hospitals cannot afford to miss.

Another recent release from the center, the congestive heart failure implementation guide, reviews methods to optimize heart failure care during and after hospital admission episodes. Congestive heart failure is responsible for 11 million physician visits annually and more hospitalizations than all forms of cancer combined.

Other recently added tool kits cover COPD, glycemic control, opioid monitoring, delirium, and pain management.

For more information on these tool kits and how the Center for Hospital Innovation and Improvement can share its proven best practices with your hospital, visit www.hospitalmedicine.org/CenterTJ16.

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.