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Turning for Ulcer Reduction: A Multi-Site Randomized Clinical Trial in Nursing Homes
Clinical question: Is there a difference between repositioning intervals of two, three, or four hours in pressure ulcer formation in nursing home residents on high-density foam mattresses?
Background: Pressure ulcer formation in nursing home residents is a common problem. Current standard of care requires repositioning every two hours in patients who are at risk for pressure ulcer formation. Few studies have been performed to assess a difference in repositioning interval. This study was conducted to see if there is a difference in pressure ulcer formation among residents on high-density foam mattresses at moderate to high risk (according to the Braden scale).
Study design: Multi-site, randomized, clinical trial.
Setting: Twenty U.S. and seven Canadian nursing homes using high-density foam mattresses.
Synopsis: A multi-site, randomized clinical trial was executed in 20 U.S. and seven Canadian nursing homes. More than 900 residents were randomized to two-, three-, or four-hour intervals for repositioning. All participants were at either moderate (13-14) or high (10-12) risk on the Braden scale for pressure ulcer formation. All facilities used high-density foam mattresses. All participants were monitored for pressure ulcer formation on the sacrum/coccyx, heel, or trochanter for three consecutive weeks.
There was no significant difference in pressure ulcer formation between the two-, three-, or four-hour interval repositioning groups. There was no significant difference in pressure ulcer formation between the moderate or high-risk groups. Only 2% of participants developed a pressure ulcer, all stage I or II.
It is not clear if the outcomes were purely related to the repositioning intervals, as this study group had a much lower rate of pressure ulcer formation compared to national averages and previous studies. The high-density foam mattress might have improved outcomes by evenly redistributing pressure so that less frequent repositioning was required. The level of documentation may have led to earlier recognition of early stage pressure ulcers as well. This study also was limited to nursing home residents at moderate to high risk of pressure ulcer development.
Bottom line: There is no significant difference in pressure ulcer formation between repositioning intervals of two, three, or four hours among moderate and high-risk nursing home residents using high-density foam mattresses.
Citation: Bergstrom N, Horn SD, Rapp MP, Stern A, Barrett R, Watkiss M. Turning for ulcer reduction: a multisite randomized clinical trial in nursing homes. 2013;61(10):1705-1713.
Clinical question: Is there a difference between repositioning intervals of two, three, or four hours in pressure ulcer formation in nursing home residents on high-density foam mattresses?
Background: Pressure ulcer formation in nursing home residents is a common problem. Current standard of care requires repositioning every two hours in patients who are at risk for pressure ulcer formation. Few studies have been performed to assess a difference in repositioning interval. This study was conducted to see if there is a difference in pressure ulcer formation among residents on high-density foam mattresses at moderate to high risk (according to the Braden scale).
Study design: Multi-site, randomized, clinical trial.
Setting: Twenty U.S. and seven Canadian nursing homes using high-density foam mattresses.
Synopsis: A multi-site, randomized clinical trial was executed in 20 U.S. and seven Canadian nursing homes. More than 900 residents were randomized to two-, three-, or four-hour intervals for repositioning. All participants were at either moderate (13-14) or high (10-12) risk on the Braden scale for pressure ulcer formation. All facilities used high-density foam mattresses. All participants were monitored for pressure ulcer formation on the sacrum/coccyx, heel, or trochanter for three consecutive weeks.
There was no significant difference in pressure ulcer formation between the two-, three-, or four-hour interval repositioning groups. There was no significant difference in pressure ulcer formation between the moderate or high-risk groups. Only 2% of participants developed a pressure ulcer, all stage I or II.
It is not clear if the outcomes were purely related to the repositioning intervals, as this study group had a much lower rate of pressure ulcer formation compared to national averages and previous studies. The high-density foam mattress might have improved outcomes by evenly redistributing pressure so that less frequent repositioning was required. The level of documentation may have led to earlier recognition of early stage pressure ulcers as well. This study also was limited to nursing home residents at moderate to high risk of pressure ulcer development.
Bottom line: There is no significant difference in pressure ulcer formation between repositioning intervals of two, three, or four hours among moderate and high-risk nursing home residents using high-density foam mattresses.
Citation: Bergstrom N, Horn SD, Rapp MP, Stern A, Barrett R, Watkiss M. Turning for ulcer reduction: a multisite randomized clinical trial in nursing homes. 2013;61(10):1705-1713.
Clinical question: Is there a difference between repositioning intervals of two, three, or four hours in pressure ulcer formation in nursing home residents on high-density foam mattresses?
Background: Pressure ulcer formation in nursing home residents is a common problem. Current standard of care requires repositioning every two hours in patients who are at risk for pressure ulcer formation. Few studies have been performed to assess a difference in repositioning interval. This study was conducted to see if there is a difference in pressure ulcer formation among residents on high-density foam mattresses at moderate to high risk (according to the Braden scale).
Study design: Multi-site, randomized, clinical trial.
Setting: Twenty U.S. and seven Canadian nursing homes using high-density foam mattresses.
Synopsis: A multi-site, randomized clinical trial was executed in 20 U.S. and seven Canadian nursing homes. More than 900 residents were randomized to two-, three-, or four-hour intervals for repositioning. All participants were at either moderate (13-14) or high (10-12) risk on the Braden scale for pressure ulcer formation. All facilities used high-density foam mattresses. All participants were monitored for pressure ulcer formation on the sacrum/coccyx, heel, or trochanter for three consecutive weeks.
There was no significant difference in pressure ulcer formation between the two-, three-, or four-hour interval repositioning groups. There was no significant difference in pressure ulcer formation between the moderate or high-risk groups. Only 2% of participants developed a pressure ulcer, all stage I or II.
It is not clear if the outcomes were purely related to the repositioning intervals, as this study group had a much lower rate of pressure ulcer formation compared to national averages and previous studies. The high-density foam mattress might have improved outcomes by evenly redistributing pressure so that less frequent repositioning was required. The level of documentation may have led to earlier recognition of early stage pressure ulcers as well. This study also was limited to nursing home residents at moderate to high risk of pressure ulcer development.
Bottom line: There is no significant difference in pressure ulcer formation between repositioning intervals of two, three, or four hours among moderate and high-risk nursing home residents using high-density foam mattresses.
Citation: Bergstrom N, Horn SD, Rapp MP, Stern A, Barrett R, Watkiss M. Turning for ulcer reduction: a multisite randomized clinical trial in nursing homes. 2013;61(10):1705-1713.
Antibiotic Resistance Threats in the United States, 2013
Clinical question: What antibiotic-resistant bacteria are the greatest threats for the next 10 years?
Background: Two million people suffer antibiotic-resistant infections yearly, and 23,000 die each year as a result. Most of these infections occur in the community, but deaths usually occur in healthcare settings. Cost estimates vary but may be as high as $20 billion in excess direct healthcare costs.
Study design: The CDC used several different surveys and databanks, including the National Antimicrobial Resistance Monitoring System, to collect data. The threat level for antibiotic-resistant bacteria was determined using several factors: clinical impact, economic impact, incidence, 10-year projection of incidence, transmissibility, availability of effective antibiotics, and barriers to prevention.
Setting: United States.
Synopsis: The CDC has three classifications of antibiotic-resistant bacteria: urgent, serious, and concerning. Urgent threats are high-consequence, antibiotic-resistant threats because of significant risks identified across several criteria. These threats might not currently be widespread but have the potential to become so and require urgent public health attention to identify infections and to limit transmission. They include carbapenem-resistant Enterobacteriaceae, drug-resistant Neisseria gonorrhoeae, and Clostridium difficile (does not have true resistance, but is a consequence of antibiotic overuse).
Serious threats are significant antibiotic-resistant threats. These threats will worsen and might become urgent without ongoing public health monitoring and prevention activities. They include multidrug-resistant Acinetobacter, drug-resistant Campylobacter, fluconazole-resistant Candida (a fungus), extended-spectrum β-lactamase-producing Enterobacteriaceae, vancomycin-resistant Enterococcus, multidrug-resistant Pseudomonas aeruginosa, drug-resistant non-typhoidal Salmonella, drug-resistant Salmonella Typhimurium, drug-resistant Shigella, methicillin-resistant Staphylococcus aureus, drug-resistant Streptococcus pneumonia, and drug-resistant tuberculosis.
Concerning threats are bacteria for which the threat of antibiotic resistance is low, and/ or there are multiple therapeutic options for resistant infections. These bacterial pathogens cause severe illness. Threats in this category require monitoring and, in some cases, rapid incident or outbreak response. These include vancomycin-resistant Staphylococcus aureus, erythromycin-resistant Group A Streptococcus, and clindamycin-resistant Group B Streptococcus. Research has shown patients with resistant infections have significantly longer hospital stays, delayed recuperation, long-term disability, and higher mortality. As resistance to current antibiotics occurs, providers are forced to use antibiotics that are more toxic, more expensive, and less effective.
The CDC recommends four core actions to fight antibiotic resistance:
- Preventing infections from occurring and preventing resistant bacteria from spreading (immunization, infection control, screening, treatment, and education);
- Tracking resistant bacteria;
- Improving the use of antibiotics (antibiotic stewardship); and
- Promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.
Bottom line: Antibiotics are a limited resource. The more antibiotics are used today, the less likely they will continue to be effective in the future. The CDC lists 18 antibiotic-resistant organisms as urgent, serious, or concerning and recommends actions to combat the spread of current organisms and emergence of new antibiotic organisms.
Citation: Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013. CDC website. September 16, 2013. Available at: www.cdc.gov/drugresistance/threat-report-2013. Accessed Nov. 30, 2013.
Clinical question: What antibiotic-resistant bacteria are the greatest threats for the next 10 years?
Background: Two million people suffer antibiotic-resistant infections yearly, and 23,000 die each year as a result. Most of these infections occur in the community, but deaths usually occur in healthcare settings. Cost estimates vary but may be as high as $20 billion in excess direct healthcare costs.
Study design: The CDC used several different surveys and databanks, including the National Antimicrobial Resistance Monitoring System, to collect data. The threat level for antibiotic-resistant bacteria was determined using several factors: clinical impact, economic impact, incidence, 10-year projection of incidence, transmissibility, availability of effective antibiotics, and barriers to prevention.
Setting: United States.
Synopsis: The CDC has three classifications of antibiotic-resistant bacteria: urgent, serious, and concerning. Urgent threats are high-consequence, antibiotic-resistant threats because of significant risks identified across several criteria. These threats might not currently be widespread but have the potential to become so and require urgent public health attention to identify infections and to limit transmission. They include carbapenem-resistant Enterobacteriaceae, drug-resistant Neisseria gonorrhoeae, and Clostridium difficile (does not have true resistance, but is a consequence of antibiotic overuse).
Serious threats are significant antibiotic-resistant threats. These threats will worsen and might become urgent without ongoing public health monitoring and prevention activities. They include multidrug-resistant Acinetobacter, drug-resistant Campylobacter, fluconazole-resistant Candida (a fungus), extended-spectrum β-lactamase-producing Enterobacteriaceae, vancomycin-resistant Enterococcus, multidrug-resistant Pseudomonas aeruginosa, drug-resistant non-typhoidal Salmonella, drug-resistant Salmonella Typhimurium, drug-resistant Shigella, methicillin-resistant Staphylococcus aureus, drug-resistant Streptococcus pneumonia, and drug-resistant tuberculosis.
Concerning threats are bacteria for which the threat of antibiotic resistance is low, and/ or there are multiple therapeutic options for resistant infections. These bacterial pathogens cause severe illness. Threats in this category require monitoring and, in some cases, rapid incident or outbreak response. These include vancomycin-resistant Staphylococcus aureus, erythromycin-resistant Group A Streptococcus, and clindamycin-resistant Group B Streptococcus. Research has shown patients with resistant infections have significantly longer hospital stays, delayed recuperation, long-term disability, and higher mortality. As resistance to current antibiotics occurs, providers are forced to use antibiotics that are more toxic, more expensive, and less effective.
The CDC recommends four core actions to fight antibiotic resistance:
- Preventing infections from occurring and preventing resistant bacteria from spreading (immunization, infection control, screening, treatment, and education);
- Tracking resistant bacteria;
- Improving the use of antibiotics (antibiotic stewardship); and
- Promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.
Bottom line: Antibiotics are a limited resource. The more antibiotics are used today, the less likely they will continue to be effective in the future. The CDC lists 18 antibiotic-resistant organisms as urgent, serious, or concerning and recommends actions to combat the spread of current organisms and emergence of new antibiotic organisms.
Citation: Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013. CDC website. September 16, 2013. Available at: www.cdc.gov/drugresistance/threat-report-2013. Accessed Nov. 30, 2013.
Clinical question: What antibiotic-resistant bacteria are the greatest threats for the next 10 years?
Background: Two million people suffer antibiotic-resistant infections yearly, and 23,000 die each year as a result. Most of these infections occur in the community, but deaths usually occur in healthcare settings. Cost estimates vary but may be as high as $20 billion in excess direct healthcare costs.
Study design: The CDC used several different surveys and databanks, including the National Antimicrobial Resistance Monitoring System, to collect data. The threat level for antibiotic-resistant bacteria was determined using several factors: clinical impact, economic impact, incidence, 10-year projection of incidence, transmissibility, availability of effective antibiotics, and barriers to prevention.
Setting: United States.
Synopsis: The CDC has three classifications of antibiotic-resistant bacteria: urgent, serious, and concerning. Urgent threats are high-consequence, antibiotic-resistant threats because of significant risks identified across several criteria. These threats might not currently be widespread but have the potential to become so and require urgent public health attention to identify infections and to limit transmission. They include carbapenem-resistant Enterobacteriaceae, drug-resistant Neisseria gonorrhoeae, and Clostridium difficile (does not have true resistance, but is a consequence of antibiotic overuse).
Serious threats are significant antibiotic-resistant threats. These threats will worsen and might become urgent without ongoing public health monitoring and prevention activities. They include multidrug-resistant Acinetobacter, drug-resistant Campylobacter, fluconazole-resistant Candida (a fungus), extended-spectrum β-lactamase-producing Enterobacteriaceae, vancomycin-resistant Enterococcus, multidrug-resistant Pseudomonas aeruginosa, drug-resistant non-typhoidal Salmonella, drug-resistant Salmonella Typhimurium, drug-resistant Shigella, methicillin-resistant Staphylococcus aureus, drug-resistant Streptococcus pneumonia, and drug-resistant tuberculosis.
Concerning threats are bacteria for which the threat of antibiotic resistance is low, and/ or there are multiple therapeutic options for resistant infections. These bacterial pathogens cause severe illness. Threats in this category require monitoring and, in some cases, rapid incident or outbreak response. These include vancomycin-resistant Staphylococcus aureus, erythromycin-resistant Group A Streptococcus, and clindamycin-resistant Group B Streptococcus. Research has shown patients with resistant infections have significantly longer hospital stays, delayed recuperation, long-term disability, and higher mortality. As resistance to current antibiotics occurs, providers are forced to use antibiotics that are more toxic, more expensive, and less effective.
The CDC recommends four core actions to fight antibiotic resistance:
- Preventing infections from occurring and preventing resistant bacteria from spreading (immunization, infection control, screening, treatment, and education);
- Tracking resistant bacteria;
- Improving the use of antibiotics (antibiotic stewardship); and
- Promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.
Bottom line: Antibiotics are a limited resource. The more antibiotics are used today, the less likely they will continue to be effective in the future. The CDC lists 18 antibiotic-resistant organisms as urgent, serious, or concerning and recommends actions to combat the spread of current organisms and emergence of new antibiotic organisms.
Citation: Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013. CDC website. September 16, 2013. Available at: www.cdc.gov/drugresistance/threat-report-2013. Accessed Nov. 30, 2013.
Hospitalists Less-Likely Targets of Malpractice Claims Than Other Physicians
In the article "Liability Impact of the Hospitalist Model of Care," Adam Schaffer, MD, a hospitalist at Brigham and Women's Hospital in Boston, writes that hospitalists average 0.52 malpractice claims per 100 physician coverage years (PCYs), while non-hospitalist internal medicine physicians have a rate of 1.91 claims per 100 PCYs. By comparison, ED physicians average 3.5 claims per 100 PYCs, general surgeons average 4.7 claims, and OB/GYNs average 5.56 claims (P<0.001 for all comparisons).
"I was fairly surprised because the magnitude of the decreased risk…was fairly significant and statistically significant," Dr. Schaffer says. He notes that having relatively short interactions with patients and the difficulties of care transitions would appear to make it difficult for hospitalists to establish the type of close relationships with patients that can help prevent malpractice claims. However, hospitalists have overcome that hurdle.
An editorial that accompanies the JHM study contends that hospitalists develop and hone skills "which allow them to quickly establish rapport with patients and families." The editorial was penned by hospitalist Kevin O'Leary, MD, MS, SFHM, of Northwestern University Feinberg School of Medicine in Chicago, and JHM Editor-in-Chief Andrew Auerbach, MD, MPH, SFHM, of the University of California, San Francisco.
"Even though you may have a relatively brief relationship with the patient," Dr. Schaffer adds, "the fact that you're in the hospital, able to see them, meet with them, answer their questions multiple times a day if need be, that may actually help establish a strong and robust physician-patient relationship."
Visit SHM's blog, "The Hospital Leader," for an exploration of malpractice suits and a Q&A with study author Adam Schaffer.
In the article "Liability Impact of the Hospitalist Model of Care," Adam Schaffer, MD, a hospitalist at Brigham and Women's Hospital in Boston, writes that hospitalists average 0.52 malpractice claims per 100 physician coverage years (PCYs), while non-hospitalist internal medicine physicians have a rate of 1.91 claims per 100 PCYs. By comparison, ED physicians average 3.5 claims per 100 PYCs, general surgeons average 4.7 claims, and OB/GYNs average 5.56 claims (P<0.001 for all comparisons).
"I was fairly surprised because the magnitude of the decreased risk…was fairly significant and statistically significant," Dr. Schaffer says. He notes that having relatively short interactions with patients and the difficulties of care transitions would appear to make it difficult for hospitalists to establish the type of close relationships with patients that can help prevent malpractice claims. However, hospitalists have overcome that hurdle.
An editorial that accompanies the JHM study contends that hospitalists develop and hone skills "which allow them to quickly establish rapport with patients and families." The editorial was penned by hospitalist Kevin O'Leary, MD, MS, SFHM, of Northwestern University Feinberg School of Medicine in Chicago, and JHM Editor-in-Chief Andrew Auerbach, MD, MPH, SFHM, of the University of California, San Francisco.
"Even though you may have a relatively brief relationship with the patient," Dr. Schaffer adds, "the fact that you're in the hospital, able to see them, meet with them, answer their questions multiple times a day if need be, that may actually help establish a strong and robust physician-patient relationship."
Visit SHM's blog, "The Hospital Leader," for an exploration of malpractice suits and a Q&A with study author Adam Schaffer.
In the article "Liability Impact of the Hospitalist Model of Care," Adam Schaffer, MD, a hospitalist at Brigham and Women's Hospital in Boston, writes that hospitalists average 0.52 malpractice claims per 100 physician coverage years (PCYs), while non-hospitalist internal medicine physicians have a rate of 1.91 claims per 100 PCYs. By comparison, ED physicians average 3.5 claims per 100 PYCs, general surgeons average 4.7 claims, and OB/GYNs average 5.56 claims (P<0.001 for all comparisons).
"I was fairly surprised because the magnitude of the decreased risk…was fairly significant and statistically significant," Dr. Schaffer says. He notes that having relatively short interactions with patients and the difficulties of care transitions would appear to make it difficult for hospitalists to establish the type of close relationships with patients that can help prevent malpractice claims. However, hospitalists have overcome that hurdle.
An editorial that accompanies the JHM study contends that hospitalists develop and hone skills "which allow them to quickly establish rapport with patients and families." The editorial was penned by hospitalist Kevin O'Leary, MD, MS, SFHM, of Northwestern University Feinberg School of Medicine in Chicago, and JHM Editor-in-Chief Andrew Auerbach, MD, MPH, SFHM, of the University of California, San Francisco.
"Even though you may have a relatively brief relationship with the patient," Dr. Schaffer adds, "the fact that you're in the hospital, able to see them, meet with them, answer their questions multiple times a day if need be, that may actually help establish a strong and robust physician-patient relationship."
Visit SHM's blog, "The Hospital Leader," for an exploration of malpractice suits and a Q&A with study author Adam Schaffer.
Once-Weekly Antibiotic Might Be Effective for Treatment of Acute Bacterial Skin Infections
Background: Acute bacterial skin infections are common and often require hospitalization for intravenous antibiotic administration. Treatment covering gram-positive bacteria usually is indicated. Dalbavancin is effective against gram-positives, including MRSA. Its long half-life makes it an attractive alternative to other commonly used antibiotics, which require more frequent dosing.
Study design: Phase 3, double-blinded RCT.
Setting: Multiple international centers.
Synopsis: Researchers randomized 1,312 patients with acute bacterial skin and skin-structure infections with signs of systemic infection requiring intravenous antibiotics to receive dalbavancin on days one and eight, with placebo on other days, or several doses of vancomycin with an option to switch to oral linezolid. The primary endpoint was cessation of spread of erythema and temperature of =37.6°C at 48–72 hours. Secondary endpoints included a decrease in lesion area of =20% at 48–72 hours and clinical success at end of therapy (determined by clinical and historical features). Results of the primary endpoint were similar with dalbavancin and vancomycin-linezolid groups (79.7% and 79.8%, respectively) and were within 10 percentage points of noninferiority. The secondary endpoints were similar between both groups. Limitations of the study were the early primary endpoint, lack of noninferiority analysis of the secondary endpoints, and cost-effective analysis.
Bottom line: Once-weekly dalbavancin appears to be similarly efficacious to intravenous vancomycin in the treatment of acute bacterial skin infections in terms of outcomes within 48–72 hours of therapy and might provide an alternative to continued inpatient hospitalization for intravenous antibiotics in stable patients.
Citation: Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014;370(23):2169-2179.
Background: Acute bacterial skin infections are common and often require hospitalization for intravenous antibiotic administration. Treatment covering gram-positive bacteria usually is indicated. Dalbavancin is effective against gram-positives, including MRSA. Its long half-life makes it an attractive alternative to other commonly used antibiotics, which require more frequent dosing.
Study design: Phase 3, double-blinded RCT.
Setting: Multiple international centers.
Synopsis: Researchers randomized 1,312 patients with acute bacterial skin and skin-structure infections with signs of systemic infection requiring intravenous antibiotics to receive dalbavancin on days one and eight, with placebo on other days, or several doses of vancomycin with an option to switch to oral linezolid. The primary endpoint was cessation of spread of erythema and temperature of =37.6°C at 48–72 hours. Secondary endpoints included a decrease in lesion area of =20% at 48–72 hours and clinical success at end of therapy (determined by clinical and historical features). Results of the primary endpoint were similar with dalbavancin and vancomycin-linezolid groups (79.7% and 79.8%, respectively) and were within 10 percentage points of noninferiority. The secondary endpoints were similar between both groups. Limitations of the study were the early primary endpoint, lack of noninferiority analysis of the secondary endpoints, and cost-effective analysis.
Bottom line: Once-weekly dalbavancin appears to be similarly efficacious to intravenous vancomycin in the treatment of acute bacterial skin infections in terms of outcomes within 48–72 hours of therapy and might provide an alternative to continued inpatient hospitalization for intravenous antibiotics in stable patients.
Citation: Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014;370(23):2169-2179.
Background: Acute bacterial skin infections are common and often require hospitalization for intravenous antibiotic administration. Treatment covering gram-positive bacteria usually is indicated. Dalbavancin is effective against gram-positives, including MRSA. Its long half-life makes it an attractive alternative to other commonly used antibiotics, which require more frequent dosing.
Study design: Phase 3, double-blinded RCT.
Setting: Multiple international centers.
Synopsis: Researchers randomized 1,312 patients with acute bacterial skin and skin-structure infections with signs of systemic infection requiring intravenous antibiotics to receive dalbavancin on days one and eight, with placebo on other days, or several doses of vancomycin with an option to switch to oral linezolid. The primary endpoint was cessation of spread of erythema and temperature of =37.6°C at 48–72 hours. Secondary endpoints included a decrease in lesion area of =20% at 48–72 hours and clinical success at end of therapy (determined by clinical and historical features). Results of the primary endpoint were similar with dalbavancin and vancomycin-linezolid groups (79.7% and 79.8%, respectively) and were within 10 percentage points of noninferiority. The secondary endpoints were similar between both groups. Limitations of the study were the early primary endpoint, lack of noninferiority analysis of the secondary endpoints, and cost-effective analysis.
Bottom line: Once-weekly dalbavancin appears to be similarly efficacious to intravenous vancomycin in the treatment of acute bacterial skin infections in terms of outcomes within 48–72 hours of therapy and might provide an alternative to continued inpatient hospitalization for intravenous antibiotics in stable patients.
Citation: Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014;370(23):2169-2179.
Holding Chambers (Spacers) vs. Nebulizers for Acute Asthma
Clinical question: Are beta-2 agonists as effective when administered through a holding chamber (spacer) as they are when administered by a nebulizer?
Background: During an acute asthma attack, beta-2 agonists must be delivered to the peripheral airways. There has been considerable controversy regarding the use of a spacer compared with a nebulizer. Aside from admission rates and length of stay, factors taken into account include cost, maintenance of nebulizer machines, and infection control (potential of cross-infection via nebulizers).
Study design: Meta-analysis review of randomized controlled trials (RCTs).
Setting: Multi-centered, worldwide studies from community setting and EDs.
Synopsis: In 39 studies of patients with an acute asthma attack (selected from Cochrane Airways Group Specialized Register), the hospital admission rates did not differ on the basis of delivery method in 729 adults (risk ratio=0.94, confidence interval 0.61-1.43) or in 1,897 children (risk ratio=0.71, confidence interval 0.47-1.08). Secondary outcomes included the duration of time in the ED and the duration of hospital admission. Time spent in the ED varied for adults but was shorter for children with spacers (based on three studies). Duration of hospital admission also did not differ when modes of delivery were compared.
Bottom line: Providing beta-2 agonists using nebulizers during an acute asthma attack is not more effective than administration using a spacer.
Citation: Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013;9:CD000052.
Clinical question: Are beta-2 agonists as effective when administered through a holding chamber (spacer) as they are when administered by a nebulizer?
Background: During an acute asthma attack, beta-2 agonists must be delivered to the peripheral airways. There has been considerable controversy regarding the use of a spacer compared with a nebulizer. Aside from admission rates and length of stay, factors taken into account include cost, maintenance of nebulizer machines, and infection control (potential of cross-infection via nebulizers).
Study design: Meta-analysis review of randomized controlled trials (RCTs).
Setting: Multi-centered, worldwide studies from community setting and EDs.
Synopsis: In 39 studies of patients with an acute asthma attack (selected from Cochrane Airways Group Specialized Register), the hospital admission rates did not differ on the basis of delivery method in 729 adults (risk ratio=0.94, confidence interval 0.61-1.43) or in 1,897 children (risk ratio=0.71, confidence interval 0.47-1.08). Secondary outcomes included the duration of time in the ED and the duration of hospital admission. Time spent in the ED varied for adults but was shorter for children with spacers (based on three studies). Duration of hospital admission also did not differ when modes of delivery were compared.
Bottom line: Providing beta-2 agonists using nebulizers during an acute asthma attack is not more effective than administration using a spacer.
Citation: Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013;9:CD000052.
Clinical question: Are beta-2 agonists as effective when administered through a holding chamber (spacer) as they are when administered by a nebulizer?
Background: During an acute asthma attack, beta-2 agonists must be delivered to the peripheral airways. There has been considerable controversy regarding the use of a spacer compared with a nebulizer. Aside from admission rates and length of stay, factors taken into account include cost, maintenance of nebulizer machines, and infection control (potential of cross-infection via nebulizers).
Study design: Meta-analysis review of randomized controlled trials (RCTs).
Setting: Multi-centered, worldwide studies from community setting and EDs.
Synopsis: In 39 studies of patients with an acute asthma attack (selected from Cochrane Airways Group Specialized Register), the hospital admission rates did not differ on the basis of delivery method in 729 adults (risk ratio=0.94, confidence interval 0.61-1.43) or in 1,897 children (risk ratio=0.71, confidence interval 0.47-1.08). Secondary outcomes included the duration of time in the ED and the duration of hospital admission. Time spent in the ED varied for adults but was shorter for children with spacers (based on three studies). Duration of hospital admission also did not differ when modes of delivery were compared.
Bottom line: Providing beta-2 agonists using nebulizers during an acute asthma attack is not more effective than administration using a spacer.
Citation: Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013;9:CD000052.
Long-Term Cognitive Impairment after Critical Illness
Clinical question: Are a longer duration of delirium and higher doses of sedatives associated with cognitive impairment in the hospital?
Background: Survivors of critical illness are at risk for prolonged cognitive dysfunction. Delirium (and factors associated with delirium, namely sedative and analgesic medications) has been implicated in cognitive dysfunction.
Study design: Prospective cohort study.
Setting: Multi-center, academic, and acute care hospitals.
Synopsis: The study examined 821 adults admitted to the ICU with respiratory failure, cardiogenic shock, or septic shock. Patients excluded were those with pre-existing cognitive impairment, those with psychotic disorders, and those for whom follow-up would not be possible. Two risk factors measured were duration of delirium and use of sedative/analgesics. Delirium was assessed at three and 12 months using the CAM-ICU algorithm in the ICU by trained psychology professionals who were unaware of the patients’ in-hospital course.
At three months, 40% of patients had global cognition scores that were 1.5 standard deviations (SD) below population mean (similar to traumatic brain injury), and 26% had scores two SD below population mean (similar to mild Alzheimer’s). At 12 months, 34% had scores similar to traumatic brain injury patients, and 24% had scores similar to mild Alzheimer’s. A longer duration of delirium was associated with worse global cognition at three and 12 months. Use of sedatives/analgesics was not associated with cognitive impairment.
Bottom line: Critically ill patients in the ICU who experience a longer duration of delirium are at risk of long-term cognitive impairments lasting 12 months.
Citation: Pandharipande PP, Girard TD, Jackson JC, et al. Long-term cognitive impairment after critical illness. N Engl J Med. 2013;369(14):1306-1316.
Clinical question: Are a longer duration of delirium and higher doses of sedatives associated with cognitive impairment in the hospital?
Background: Survivors of critical illness are at risk for prolonged cognitive dysfunction. Delirium (and factors associated with delirium, namely sedative and analgesic medications) has been implicated in cognitive dysfunction.
Study design: Prospective cohort study.
Setting: Multi-center, academic, and acute care hospitals.
Synopsis: The study examined 821 adults admitted to the ICU with respiratory failure, cardiogenic shock, or septic shock. Patients excluded were those with pre-existing cognitive impairment, those with psychotic disorders, and those for whom follow-up would not be possible. Two risk factors measured were duration of delirium and use of sedative/analgesics. Delirium was assessed at three and 12 months using the CAM-ICU algorithm in the ICU by trained psychology professionals who were unaware of the patients’ in-hospital course.
At three months, 40% of patients had global cognition scores that were 1.5 standard deviations (SD) below population mean (similar to traumatic brain injury), and 26% had scores two SD below population mean (similar to mild Alzheimer’s). At 12 months, 34% had scores similar to traumatic brain injury patients, and 24% had scores similar to mild Alzheimer’s. A longer duration of delirium was associated with worse global cognition at three and 12 months. Use of sedatives/analgesics was not associated with cognitive impairment.
Bottom line: Critically ill patients in the ICU who experience a longer duration of delirium are at risk of long-term cognitive impairments lasting 12 months.
Citation: Pandharipande PP, Girard TD, Jackson JC, et al. Long-term cognitive impairment after critical illness. N Engl J Med. 2013;369(14):1306-1316.
Clinical question: Are a longer duration of delirium and higher doses of sedatives associated with cognitive impairment in the hospital?
Background: Survivors of critical illness are at risk for prolonged cognitive dysfunction. Delirium (and factors associated with delirium, namely sedative and analgesic medications) has been implicated in cognitive dysfunction.
Study design: Prospective cohort study.
Setting: Multi-center, academic, and acute care hospitals.
Synopsis: The study examined 821 adults admitted to the ICU with respiratory failure, cardiogenic shock, or septic shock. Patients excluded were those with pre-existing cognitive impairment, those with psychotic disorders, and those for whom follow-up would not be possible. Two risk factors measured were duration of delirium and use of sedative/analgesics. Delirium was assessed at three and 12 months using the CAM-ICU algorithm in the ICU by trained psychology professionals who were unaware of the patients’ in-hospital course.
At three months, 40% of patients had global cognition scores that were 1.5 standard deviations (SD) below population mean (similar to traumatic brain injury), and 26% had scores two SD below population mean (similar to mild Alzheimer’s). At 12 months, 34% had scores similar to traumatic brain injury patients, and 24% had scores similar to mild Alzheimer’s. A longer duration of delirium was associated with worse global cognition at three and 12 months. Use of sedatives/analgesics was not associated with cognitive impairment.
Bottom line: Critically ill patients in the ICU who experience a longer duration of delirium are at risk of long-term cognitive impairments lasting 12 months.
Citation: Pandharipande PP, Girard TD, Jackson JC, et al. Long-term cognitive impairment after critical illness. N Engl J Med. 2013;369(14):1306-1316.
Endoscopic vs. Surgical Cystogastrostomy for Pancreatic Pseudocyst Drainage
Clinical question: How does endoscopic cystogastrostomy for pancreatic pseudocyst drainage compare to the standard surgical approach?
Background: Pancreatic pseudocysts are a common complication of pancreatitis and necessitate decompression when they are accompanied by pain, infection, or obstruction. Decompression of the pseudocyst can be accomplished using either endoscopic or surgical cystogastrostomy.
Study design: Open-label, single-center, randomized trial.
Setting: Single-center U.S. hospital.
Synopsis: A total of 40 patients were randomly equalized to both treatment arms; 20 patients underwent endoscopic and 20 patients underwent surgical cystogastrostomy. Zero patients in the endoscopic therapy had a pseudocyst recurrence, compared with one patient treated surgically. Length of stay (LOS) and cost were lower for the endoscopic group compared to the surgical group (two days vs. six days, P<0.001, $7,011 vs. $15,052, P=0.003).
This study is limited due to several factors. First, patients with pancreatic necrosis were excluded; had these patients been included, the complication rates and LOS would have been higher. Second, cost difference cannot be generalized across the U.S., because Medicare payments are based on provider types and regions.
Bottom line: Endoscopic cystogastrostomy for pancreatic pseudocyst is equal to the standard surgical therapy and results in decreased LOS and reduced costs.
Citation: Varadarajulu S, Bang JY, Sutton BS, Trevino JM, Christein JD, Wilcox CM. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology. 2013;145(3):583-590.
Clinical question: How does endoscopic cystogastrostomy for pancreatic pseudocyst drainage compare to the standard surgical approach?
Background: Pancreatic pseudocysts are a common complication of pancreatitis and necessitate decompression when they are accompanied by pain, infection, or obstruction. Decompression of the pseudocyst can be accomplished using either endoscopic or surgical cystogastrostomy.
Study design: Open-label, single-center, randomized trial.
Setting: Single-center U.S. hospital.
Synopsis: A total of 40 patients were randomly equalized to both treatment arms; 20 patients underwent endoscopic and 20 patients underwent surgical cystogastrostomy. Zero patients in the endoscopic therapy had a pseudocyst recurrence, compared with one patient treated surgically. Length of stay (LOS) and cost were lower for the endoscopic group compared to the surgical group (two days vs. six days, P<0.001, $7,011 vs. $15,052, P=0.003).
This study is limited due to several factors. First, patients with pancreatic necrosis were excluded; had these patients been included, the complication rates and LOS would have been higher. Second, cost difference cannot be generalized across the U.S., because Medicare payments are based on provider types and regions.
Bottom line: Endoscopic cystogastrostomy for pancreatic pseudocyst is equal to the standard surgical therapy and results in decreased LOS and reduced costs.
Citation: Varadarajulu S, Bang JY, Sutton BS, Trevino JM, Christein JD, Wilcox CM. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology. 2013;145(3):583-590.
Clinical question: How does endoscopic cystogastrostomy for pancreatic pseudocyst drainage compare to the standard surgical approach?
Background: Pancreatic pseudocysts are a common complication of pancreatitis and necessitate decompression when they are accompanied by pain, infection, or obstruction. Decompression of the pseudocyst can be accomplished using either endoscopic or surgical cystogastrostomy.
Study design: Open-label, single-center, randomized trial.
Setting: Single-center U.S. hospital.
Synopsis: A total of 40 patients were randomly equalized to both treatment arms; 20 patients underwent endoscopic and 20 patients underwent surgical cystogastrostomy. Zero patients in the endoscopic therapy had a pseudocyst recurrence, compared with one patient treated surgically. Length of stay (LOS) and cost were lower for the endoscopic group compared to the surgical group (two days vs. six days, P<0.001, $7,011 vs. $15,052, P=0.003).
This study is limited due to several factors. First, patients with pancreatic necrosis were excluded; had these patients been included, the complication rates and LOS would have been higher. Second, cost difference cannot be generalized across the U.S., because Medicare payments are based on provider types and regions.
Bottom line: Endoscopic cystogastrostomy for pancreatic pseudocyst is equal to the standard surgical therapy and results in decreased LOS and reduced costs.
Citation: Varadarajulu S, Bang JY, Sutton BS, Trevino JM, Christein JD, Wilcox CM. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology. 2013;145(3):583-590.
Single vs. Dual Antiplatelet Therapy after Stroke
Clinical question: Is dual antiplatelet therapy more beneficial or harmful than monotherapy after ischemic stroke?
Background: It is recommended that patients with ischemic stroke or transient ischemic attack (TIA) receive lifelong antiplatelet therapy; however, there have been insufficient studies evaluating the long-term safety of dual antiplatelet therapy.
Study design: Meta-analysis of randomized controlled trials (RCTs)
Setting: Data from PubMed, Embase, and the Cochrane Central Register of Controlled Trials.
Synopsis: Data from seven RCTs, including 39,574 patients with recent TIA or ischemic stroke, were reviewed. Comparisons were made regarding occurrence of intracranial hemorrhage (ICH) and recurrent stroke between patients receiving dual antiplatelet therapy and those receiving aspirin or clopidogrel monotherapy. All patients were treated for at least one year.
There was no difference in recurrent stroke or ICH between patients on dual antiplatelet therapy versus aspirin monotherapy. Patients treated with dual antiplatelet therapy did have a 46% increased risk of ICH without any additional protective benefit for recurrent stroke or TIA when compared with patients on clopidogrel monotherapy.
This information should not be applied in the acute setting, given the high risk of stroke after TIA or ischemic stroke. One major limitation of this study was that the individual trials used different combinations of dual antiplatelet therapy.
Bottom line: The risk of recurrent stroke or TIA after dual antiplatelet therapy and after monotherapy with aspirin or clopidogrel is equal, but the risk of ICH compared to clopidogrel monotherapy is increased.
Citation: Lee M, Saver JL, Hong KS, Rao NM, Wu YL, Ovbiagele B. Risk-benefit profile of long-term dual- versus single-antiplatelet therapy among patients with ischemic stroke: a systematic review and meta-analysis. Ann Intern Med. 2013;159(7):463-470.
Clinical question: Is dual antiplatelet therapy more beneficial or harmful than monotherapy after ischemic stroke?
Background: It is recommended that patients with ischemic stroke or transient ischemic attack (TIA) receive lifelong antiplatelet therapy; however, there have been insufficient studies evaluating the long-term safety of dual antiplatelet therapy.
Study design: Meta-analysis of randomized controlled trials (RCTs)
Setting: Data from PubMed, Embase, and the Cochrane Central Register of Controlled Trials.
Synopsis: Data from seven RCTs, including 39,574 patients with recent TIA or ischemic stroke, were reviewed. Comparisons were made regarding occurrence of intracranial hemorrhage (ICH) and recurrent stroke between patients receiving dual antiplatelet therapy and those receiving aspirin or clopidogrel monotherapy. All patients were treated for at least one year.
There was no difference in recurrent stroke or ICH between patients on dual antiplatelet therapy versus aspirin monotherapy. Patients treated with dual antiplatelet therapy did have a 46% increased risk of ICH without any additional protective benefit for recurrent stroke or TIA when compared with patients on clopidogrel monotherapy.
This information should not be applied in the acute setting, given the high risk of stroke after TIA or ischemic stroke. One major limitation of this study was that the individual trials used different combinations of dual antiplatelet therapy.
Bottom line: The risk of recurrent stroke or TIA after dual antiplatelet therapy and after monotherapy with aspirin or clopidogrel is equal, but the risk of ICH compared to clopidogrel monotherapy is increased.
Citation: Lee M, Saver JL, Hong KS, Rao NM, Wu YL, Ovbiagele B. Risk-benefit profile of long-term dual- versus single-antiplatelet therapy among patients with ischemic stroke: a systematic review and meta-analysis. Ann Intern Med. 2013;159(7):463-470.
Clinical question: Is dual antiplatelet therapy more beneficial or harmful than monotherapy after ischemic stroke?
Background: It is recommended that patients with ischemic stroke or transient ischemic attack (TIA) receive lifelong antiplatelet therapy; however, there have been insufficient studies evaluating the long-term safety of dual antiplatelet therapy.
Study design: Meta-analysis of randomized controlled trials (RCTs)
Setting: Data from PubMed, Embase, and the Cochrane Central Register of Controlled Trials.
Synopsis: Data from seven RCTs, including 39,574 patients with recent TIA or ischemic stroke, were reviewed. Comparisons were made regarding occurrence of intracranial hemorrhage (ICH) and recurrent stroke between patients receiving dual antiplatelet therapy and those receiving aspirin or clopidogrel monotherapy. All patients were treated for at least one year.
There was no difference in recurrent stroke or ICH between patients on dual antiplatelet therapy versus aspirin monotherapy. Patients treated with dual antiplatelet therapy did have a 46% increased risk of ICH without any additional protective benefit for recurrent stroke or TIA when compared with patients on clopidogrel monotherapy.
This information should not be applied in the acute setting, given the high risk of stroke after TIA or ischemic stroke. One major limitation of this study was that the individual trials used different combinations of dual antiplatelet therapy.
Bottom line: The risk of recurrent stroke or TIA after dual antiplatelet therapy and after monotherapy with aspirin or clopidogrel is equal, but the risk of ICH compared to clopidogrel monotherapy is increased.
Citation: Lee M, Saver JL, Hong KS, Rao NM, Wu YL, Ovbiagele B. Risk-benefit profile of long-term dual- versus single-antiplatelet therapy among patients with ischemic stroke: a systematic review and meta-analysis. Ann Intern Med. 2013;159(7):463-470.
Four Things HMGs Should Do To Prepare for Ebola
Hospitalist Monal Shah, MD, FACP, physician advisor for Parkland Health & Hospital System in Dallas, says that HM groups looking to anticipate potential cases of Ebola in their region should:
- Make sure doctors know contact information for infection-prevention staffers and their local health department;
- Double-check that physicians know how to quickly get in contact with infectious-disease (ID) specialists;
- Be aware of isolation procedures that will be necessary for this type of patient, including the use of standard, contact, and droplet precautions as well as others recommended by the Centers for Disease Control and Prevention; and
- Be diligent about asking patients about their recent travels when taking patient histories.
"For this particular disease, the travel is the big kicker," says Dr. Shah, a member of Team Hospitalist. "The other symptoms are just so nonspecific. It's vomiting, diarrhea, headaches, weakness...if we tried to admit everyone who had those types of symptoms, it wouldn't make sense."
Dr. Shah says that although he wasn't involved, emergency-preparedness discussions at his institution about dealing with potential Ebola patients started a couple of months ago as spread of the disease in Africa became global news. But although the disease has been making headlines, HM groups are unlikely to make major changes to their care delivery processes, as even just changing the primary lead from a hospitalist to an ID physician could have unintended consequences, he adds.
"Who would cover at night?" Dr. Shah asks. "Who would be the first call at night? Would our nurses know that flow?
"There are a lot of potential downstream things that would need to be changed."
Hospitalist Monal Shah, MD, FACP, physician advisor for Parkland Health & Hospital System in Dallas, says that HM groups looking to anticipate potential cases of Ebola in their region should:
- Make sure doctors know contact information for infection-prevention staffers and their local health department;
- Double-check that physicians know how to quickly get in contact with infectious-disease (ID) specialists;
- Be aware of isolation procedures that will be necessary for this type of patient, including the use of standard, contact, and droplet precautions as well as others recommended by the Centers for Disease Control and Prevention; and
- Be diligent about asking patients about their recent travels when taking patient histories.
"For this particular disease, the travel is the big kicker," says Dr. Shah, a member of Team Hospitalist. "The other symptoms are just so nonspecific. It's vomiting, diarrhea, headaches, weakness...if we tried to admit everyone who had those types of symptoms, it wouldn't make sense."
Dr. Shah says that although he wasn't involved, emergency-preparedness discussions at his institution about dealing with potential Ebola patients started a couple of months ago as spread of the disease in Africa became global news. But although the disease has been making headlines, HM groups are unlikely to make major changes to their care delivery processes, as even just changing the primary lead from a hospitalist to an ID physician could have unintended consequences, he adds.
"Who would cover at night?" Dr. Shah asks. "Who would be the first call at night? Would our nurses know that flow?
"There are a lot of potential downstream things that would need to be changed."
Hospitalist Monal Shah, MD, FACP, physician advisor for Parkland Health & Hospital System in Dallas, says that HM groups looking to anticipate potential cases of Ebola in their region should:
- Make sure doctors know contact information for infection-prevention staffers and their local health department;
- Double-check that physicians know how to quickly get in contact with infectious-disease (ID) specialists;
- Be aware of isolation procedures that will be necessary for this type of patient, including the use of standard, contact, and droplet precautions as well as others recommended by the Centers for Disease Control and Prevention; and
- Be diligent about asking patients about their recent travels when taking patient histories.
"For this particular disease, the travel is the big kicker," says Dr. Shah, a member of Team Hospitalist. "The other symptoms are just so nonspecific. It's vomiting, diarrhea, headaches, weakness...if we tried to admit everyone who had those types of symptoms, it wouldn't make sense."
Dr. Shah says that although he wasn't involved, emergency-preparedness discussions at his institution about dealing with potential Ebola patients started a couple of months ago as spread of the disease in Africa became global news. But although the disease has been making headlines, HM groups are unlikely to make major changes to their care delivery processes, as even just changing the primary lead from a hospitalist to an ID physician could have unintended consequences, he adds.
"Who would cover at night?" Dr. Shah asks. "Who would be the first call at night? Would our nurses know that flow?
"There are a lot of potential downstream things that would need to be changed."
New Oral Anticoagulants Increase GI Bleed Risk
Clinical question: Do thrombin and factor Xa inhibitors increase the risk of gastrointestinal (GI) bleeding when compared to vitamin K antagonists and heparins?
Background: New oral anticoagulants (thrombin and factor Xa inhibitors) are available and being used with increased frequency due to equal efficacy and ease of administration. Some studies indicate a higher risk of GI bleeding with these agents. Further evaluation is needed, because no reversal therapy is available.
Study design: Systematic review and meta-analysis.
Setting: Data from MEDLINE, Embase, and the Cochrane Library.
Synopsis: More than 150,000 patients from 43 randomized controlled trials were evaluated for risk of GI bleed when treated with new anticoagulants versus traditional therapy. Patients were treated for one of the following: embolism prevention from atrial fibrillation, venous thromboembolism (VTE) prophylaxis post orthopedic surgery, VTE prophylaxis of medical patients, acute VTE, and acute coronary syndrome (ACS). Use of aspirin or NSAIDs was discouraged but not documented. The odds ratio for GI bleeding with use of the new anticoagulants was 1.45, with a number needed to harm of 500. Evaluation of subgroups revealed increased GI bleed risk in patients treated for ACS and acute thrombosis versus prophylaxis. Post-surgical patients had the lowest risk.
This study was limited by the heterogeneity and differing primary outcomes (mostly efficacy rather than safety) of the included trials. Studies excluded high-risk patients, which the authors estimate to be 25%-40% of actual patients. More studies need to be done that include high-risk patients and focus on GI bleed as a primary outcome.
Bottom line: The new anticoagulants tend to have a higher incidence of GI bleed than traditional therapy, but this varies based on indication of therapy and needs further evaluation to clarify risk.
Citation: Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology. 2013;145(1):105-112.
Clinical question: Do thrombin and factor Xa inhibitors increase the risk of gastrointestinal (GI) bleeding when compared to vitamin K antagonists and heparins?
Background: New oral anticoagulants (thrombin and factor Xa inhibitors) are available and being used with increased frequency due to equal efficacy and ease of administration. Some studies indicate a higher risk of GI bleeding with these agents. Further evaluation is needed, because no reversal therapy is available.
Study design: Systematic review and meta-analysis.
Setting: Data from MEDLINE, Embase, and the Cochrane Library.
Synopsis: More than 150,000 patients from 43 randomized controlled trials were evaluated for risk of GI bleed when treated with new anticoagulants versus traditional therapy. Patients were treated for one of the following: embolism prevention from atrial fibrillation, venous thromboembolism (VTE) prophylaxis post orthopedic surgery, VTE prophylaxis of medical patients, acute VTE, and acute coronary syndrome (ACS). Use of aspirin or NSAIDs was discouraged but not documented. The odds ratio for GI bleeding with use of the new anticoagulants was 1.45, with a number needed to harm of 500. Evaluation of subgroups revealed increased GI bleed risk in patients treated for ACS and acute thrombosis versus prophylaxis. Post-surgical patients had the lowest risk.
This study was limited by the heterogeneity and differing primary outcomes (mostly efficacy rather than safety) of the included trials. Studies excluded high-risk patients, which the authors estimate to be 25%-40% of actual patients. More studies need to be done that include high-risk patients and focus on GI bleed as a primary outcome.
Bottom line: The new anticoagulants tend to have a higher incidence of GI bleed than traditional therapy, but this varies based on indication of therapy and needs further evaluation to clarify risk.
Citation: Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology. 2013;145(1):105-112.
Clinical question: Do thrombin and factor Xa inhibitors increase the risk of gastrointestinal (GI) bleeding when compared to vitamin K antagonists and heparins?
Background: New oral anticoagulants (thrombin and factor Xa inhibitors) are available and being used with increased frequency due to equal efficacy and ease of administration. Some studies indicate a higher risk of GI bleeding with these agents. Further evaluation is needed, because no reversal therapy is available.
Study design: Systematic review and meta-analysis.
Setting: Data from MEDLINE, Embase, and the Cochrane Library.
Synopsis: More than 150,000 patients from 43 randomized controlled trials were evaluated for risk of GI bleed when treated with new anticoagulants versus traditional therapy. Patients were treated for one of the following: embolism prevention from atrial fibrillation, venous thromboembolism (VTE) prophylaxis post orthopedic surgery, VTE prophylaxis of medical patients, acute VTE, and acute coronary syndrome (ACS). Use of aspirin or NSAIDs was discouraged but not documented. The odds ratio for GI bleeding with use of the new anticoagulants was 1.45, with a number needed to harm of 500. Evaluation of subgroups revealed increased GI bleed risk in patients treated for ACS and acute thrombosis versus prophylaxis. Post-surgical patients had the lowest risk.
This study was limited by the heterogeneity and differing primary outcomes (mostly efficacy rather than safety) of the included trials. Studies excluded high-risk patients, which the authors estimate to be 25%-40% of actual patients. More studies need to be done that include high-risk patients and focus on GI bleed as a primary outcome.
Bottom line: The new anticoagulants tend to have a higher incidence of GI bleed than traditional therapy, but this varies based on indication of therapy and needs further evaluation to clarify risk.
Citation: Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology. 2013;145(1):105-112.