Methotrexate holiday linked to better flu vaccine immunogenicity

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– Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.

The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.

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For now, Dr. Park said that he has advice for well-controlled RA patients who seek a flu vaccine: “I tell them to skip the next two doses of methotrexate, giving them a total of 2 weeks off. It doesn’t increase the risk of a flare, so you don’t risk anything by doing that.”

The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.

In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.

For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.

The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.

At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.

The researchers reported that there was no appreciable increase in RA disease activity.

Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.

The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.

Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.

Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.

“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”

Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.

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– Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.

The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.

copyright DesignPics/Thinkstock
For now, Dr. Park said that he has advice for well-controlled RA patients who seek a flu vaccine: “I tell them to skip the next two doses of methotrexate, giving them a total of 2 weeks off. It doesn’t increase the risk of a flare, so you don’t risk anything by doing that.”

The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.

In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.

For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.

The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.

At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.

The researchers reported that there was no appreciable increase in RA disease activity.

Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.

The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.

Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.

Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.

“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”

Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.

 

– Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.

The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.

copyright DesignPics/Thinkstock
For now, Dr. Park said that he has advice for well-controlled RA patients who seek a flu vaccine: “I tell them to skip the next two doses of methotrexate, giving them a total of 2 weeks off. It doesn’t increase the risk of a flare, so you don’t risk anything by doing that.”

The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.

In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.

For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.

The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.

At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.

The researchers reported that there was no appreciable increase in RA disease activity.

Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.

The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.

Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.

Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.

“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”

Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.

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Key clinical point: Stopping methotrexate for 2 weeks after getting a flu vaccination might improve flu vaccine immunogenicity.

Major finding: More than three-quarters of patients who had briefly stopped methotrexate and 54.5% of patients who kept using methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains at 4 weeks.

Data source: A randomized controlled trial of 320 patients with RA who were taking methotrexate.

Disclosures: The study was funded by Green Cross Corp. The presenter reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross and Hanmi Pharmaceutical.

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VIDEO: Biologic use during pregnancy had no impact on serious infection risks in infants

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Fri, 01/18/2019 - 17:09

 

– Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.

“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.

In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.

Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.

In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).

“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.

Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.

“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.

In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.

Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.

In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).

“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.

Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.

“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.

In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.

Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.

In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).

“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.

Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.

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Key clinical point: Use of biologics during pregnancy had no impact on opportunistic infection risks in infants.

Major finding: Infections occurred in 4% of infants born to mothers with RA treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy.

Study details: An observational cohort study of 1,156 pregnant women with RA.

Disclosures: Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.

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MACRA Monday: Poor HbA1c control

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Tue, 05/03/2022 - 15:21

 

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:

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Measure #1: Diabetes: HbA1c Poor Control

The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.

What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.

Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.

• Those who have Medicare Part B allowed charges of $30,000 or less.

• Those who have 100 or fewer Medicare Part B patients.

• Those who are significantly participating in an Advanced Alternative Payment Model (APM).


 

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If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Measure #1: Diabetes: HbA1c Poor Control

The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.

What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.

Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.

• Those who have Medicare Part B allowed charges of $30,000 or less.

• Those who have 100 or fewer Medicare Part B patients.

• Those who are significantly participating in an Advanced Alternative Payment Model (APM).


 

 

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Measure #1: Diabetes: HbA1c Poor Control

The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.

What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.

Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.

• Those who have Medicare Part B allowed charges of $30,000 or less.

• Those who have 100 or fewer Medicare Part B patients.

• Those who are significantly participating in an Advanced Alternative Payment Model (APM).


 

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VIDEO: Obesity linked to worse outcomes in axial spondyloarthropathy

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Sat, 12/08/2018 - 14:35

 

– Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.

“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.

“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”

Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.

Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”

The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).

“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”

She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”

ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.

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– Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.

“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.

“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”

Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.

Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”

The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).

“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”

She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”

ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.

“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.

“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”

Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.

Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”

The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).

“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”

She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”

ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Key clinical point: Obese patients with axial spondyloarthropathy have worse disease outcomes.

Major finding: In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).

Study details: A cross-sectional study of 683 patients with axial spondyloarthropathy.

Disclosures: ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie Hopkins.

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Cancer drug costs increasing despite competition

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Cancer drug costs increasing despite competition

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Cancer drug costs in the US increase substantially after launch, regardless of competition, according to a study published in the Journal of Clinical Oncology.*

Researchers studied 24 cancer drugs approved over the last 20 years and found a mean cumulative cost increase of about 37%, or 19% when adjusted for inflation.

Among drugs approved to treat hematologic malignancies, the greatest inflation-adjusted price increases were for arsenic trioxide (57%), nelarabine (55%), and rituximab (49%).

The lowest inflation-adjusted price increases were for ofatumumab (8%), clofarabine (8%), and liposomal vincristine (18%).

For this study, Daniel A. Goldstein, MD, of Emory University in Atlanta, Georgia, and his colleagues measured the monthly price trajectories of 24 cancer drugs approved by the US Food and Drug Administration. This included 10 drugs approved to treat hematologic malignancies between 1997 and 2011.

To account for discounts and rebates, the researchers used the average sales prices published by the Centers for Medicare and Medicaid Services and adjusted to general and health-related inflation rates. For each drug, the researchers calculated the cumulative and annual drug cost changes.

Results

The mean follow-up was 8 years. The mean cumulative cost increase for all 24 drugs was +36.5% (95% CI, 24.7% to 48.3%).

The general inflation-adjusted increase was +19.1% (95% CI, 11.0% to 27.2%), and the health-related inflation-adjusted increase was +8.4% (95% CI, 1.4% to 15.4%).

Only 1 of the 24 drugs studied had a price decrease over time. That drug is ziv-aflibercept, which was approved to treat metastatic colorectal cancer in 2012.

Ziv-aflibercept was launched with an annual price exceeding $110,000. After public outcry, the drug’s manufacturer, Sanofi, cut the price in half. By the end of the study’s follow-up period in 2017, the cost of ziv-aflibercept had decreased 13% (inflation-adjusted decrease of 15%, health-related inflation-adjusted decrease of 20%).

Cost changes for the drugs approved to treat hematologic malignancies are listed in the following table.

Drug (indication, approval date, years of follow-up)

Mean monthly cost at launch Mean annual cost change (SD) Cumulative cost change General and health-related inflation-adjusted change, respectively

Arsenic trioxide (APL, 2000, 12)  $11,455 +6% (4) +95% +57%, +39%
Bendamustine (CLL, NHL, 2008, 8)  $6924 +5% (5) +50% +32%, +21%
Bortezomib (MM, MCL, 2003, 12)  $5490 +4% (3) +63% +31%, +16%
Brentuximab (lymphoma, 2011, 4)  $19,482 +8% (0.1) +35% +29%, +22%
Clofarabine (ALL, 2004, 11)  $56,486 +3% (3) +31% +8%, -4%
Liposomal vincristine (ALL, 2012, 3)  $34,602 +8% (0.5) +21% +18%, +14%
Nelarabine (ALL, lymphoma, 2005, 10)  $18,513 +6% (2) +83% +55%, +39%
Ofatumumab (CLL, 2009, 6)  $4538 +3% (2) +17% +8%, -0.5%
Pralatrexate (lymphoma, 2009, 6)  $31,684 +6% (4) +43% +31%, +21%
Rituximab (NHL, CLL, 1997, 12)  $4111 +5% (0.5) +85% +49%, +32%

Abbreviations: ALL, acute lymphoblastic leukemia; APL, acute promyelocytic leukemia; CLL, chronic lymphocytic leukemia; MCL, mantle cell lymphoma; MM, multiple myeloma; NHL, non-Hodgkin lymphoma; SD, standard deviation.

The researchers noted that there was a steady increase in drug costs over the study period, regardless of whether a drug was granted a new supplemental indication, the drug had a new off-label indication, or a competitor drug was approved.

The only variable that was significantly associated with price change was the amount of time that had elapsed from a drug’s launch.

This association was significant in models in which the researchers used prices adjusted to inflation (P=0.002) and health-related inflation (P=0.023). However, it was not significant when the researchers used the actual drug price (P=0.085).

*Data in the abstract differ from data in the body of the JCO paper. This article includes data from the body of the JCO paper.

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Vials of drugs

Cancer drug costs in the US increase substantially after launch, regardless of competition, according to a study published in the Journal of Clinical Oncology.*

Researchers studied 24 cancer drugs approved over the last 20 years and found a mean cumulative cost increase of about 37%, or 19% when adjusted for inflation.

Among drugs approved to treat hematologic malignancies, the greatest inflation-adjusted price increases were for arsenic trioxide (57%), nelarabine (55%), and rituximab (49%).

The lowest inflation-adjusted price increases were for ofatumumab (8%), clofarabine (8%), and liposomal vincristine (18%).

For this study, Daniel A. Goldstein, MD, of Emory University in Atlanta, Georgia, and his colleagues measured the monthly price trajectories of 24 cancer drugs approved by the US Food and Drug Administration. This included 10 drugs approved to treat hematologic malignancies between 1997 and 2011.

To account for discounts and rebates, the researchers used the average sales prices published by the Centers for Medicare and Medicaid Services and adjusted to general and health-related inflation rates. For each drug, the researchers calculated the cumulative and annual drug cost changes.

Results

The mean follow-up was 8 years. The mean cumulative cost increase for all 24 drugs was +36.5% (95% CI, 24.7% to 48.3%).

The general inflation-adjusted increase was +19.1% (95% CI, 11.0% to 27.2%), and the health-related inflation-adjusted increase was +8.4% (95% CI, 1.4% to 15.4%).

Only 1 of the 24 drugs studied had a price decrease over time. That drug is ziv-aflibercept, which was approved to treat metastatic colorectal cancer in 2012.

Ziv-aflibercept was launched with an annual price exceeding $110,000. After public outcry, the drug’s manufacturer, Sanofi, cut the price in half. By the end of the study’s follow-up period in 2017, the cost of ziv-aflibercept had decreased 13% (inflation-adjusted decrease of 15%, health-related inflation-adjusted decrease of 20%).

Cost changes for the drugs approved to treat hematologic malignancies are listed in the following table.

Drug (indication, approval date, years of follow-up)

Mean monthly cost at launch Mean annual cost change (SD) Cumulative cost change General and health-related inflation-adjusted change, respectively

Arsenic trioxide (APL, 2000, 12)  $11,455 +6% (4) +95% +57%, +39%
Bendamustine (CLL, NHL, 2008, 8)  $6924 +5% (5) +50% +32%, +21%
Bortezomib (MM, MCL, 2003, 12)  $5490 +4% (3) +63% +31%, +16%
Brentuximab (lymphoma, 2011, 4)  $19,482 +8% (0.1) +35% +29%, +22%
Clofarabine (ALL, 2004, 11)  $56,486 +3% (3) +31% +8%, -4%
Liposomal vincristine (ALL, 2012, 3)  $34,602 +8% (0.5) +21% +18%, +14%
Nelarabine (ALL, lymphoma, 2005, 10)  $18,513 +6% (2) +83% +55%, +39%
Ofatumumab (CLL, 2009, 6)  $4538 +3% (2) +17% +8%, -0.5%
Pralatrexate (lymphoma, 2009, 6)  $31,684 +6% (4) +43% +31%, +21%
Rituximab (NHL, CLL, 1997, 12)  $4111 +5% (0.5) +85% +49%, +32%

Abbreviations: ALL, acute lymphoblastic leukemia; APL, acute promyelocytic leukemia; CLL, chronic lymphocytic leukemia; MCL, mantle cell lymphoma; MM, multiple myeloma; NHL, non-Hodgkin lymphoma; SD, standard deviation.

The researchers noted that there was a steady increase in drug costs over the study period, regardless of whether a drug was granted a new supplemental indication, the drug had a new off-label indication, or a competitor drug was approved.

The only variable that was significantly associated with price change was the amount of time that had elapsed from a drug’s launch.

This association was significant in models in which the researchers used prices adjusted to inflation (P=0.002) and health-related inflation (P=0.023). However, it was not significant when the researchers used the actual drug price (P=0.085).

*Data in the abstract differ from data in the body of the JCO paper. This article includes data from the body of the JCO paper.

Photo by Bill Branson
Vials of drugs

Cancer drug costs in the US increase substantially after launch, regardless of competition, according to a study published in the Journal of Clinical Oncology.*

Researchers studied 24 cancer drugs approved over the last 20 years and found a mean cumulative cost increase of about 37%, or 19% when adjusted for inflation.

Among drugs approved to treat hematologic malignancies, the greatest inflation-adjusted price increases were for arsenic trioxide (57%), nelarabine (55%), and rituximab (49%).

The lowest inflation-adjusted price increases were for ofatumumab (8%), clofarabine (8%), and liposomal vincristine (18%).

For this study, Daniel A. Goldstein, MD, of Emory University in Atlanta, Georgia, and his colleagues measured the monthly price trajectories of 24 cancer drugs approved by the US Food and Drug Administration. This included 10 drugs approved to treat hematologic malignancies between 1997 and 2011.

To account for discounts and rebates, the researchers used the average sales prices published by the Centers for Medicare and Medicaid Services and adjusted to general and health-related inflation rates. For each drug, the researchers calculated the cumulative and annual drug cost changes.

Results

The mean follow-up was 8 years. The mean cumulative cost increase for all 24 drugs was +36.5% (95% CI, 24.7% to 48.3%).

The general inflation-adjusted increase was +19.1% (95% CI, 11.0% to 27.2%), and the health-related inflation-adjusted increase was +8.4% (95% CI, 1.4% to 15.4%).

Only 1 of the 24 drugs studied had a price decrease over time. That drug is ziv-aflibercept, which was approved to treat metastatic colorectal cancer in 2012.

Ziv-aflibercept was launched with an annual price exceeding $110,000. After public outcry, the drug’s manufacturer, Sanofi, cut the price in half. By the end of the study’s follow-up period in 2017, the cost of ziv-aflibercept had decreased 13% (inflation-adjusted decrease of 15%, health-related inflation-adjusted decrease of 20%).

Cost changes for the drugs approved to treat hematologic malignancies are listed in the following table.

Drug (indication, approval date, years of follow-up)

Mean monthly cost at launch Mean annual cost change (SD) Cumulative cost change General and health-related inflation-adjusted change, respectively

Arsenic trioxide (APL, 2000, 12)  $11,455 +6% (4) +95% +57%, +39%
Bendamustine (CLL, NHL, 2008, 8)  $6924 +5% (5) +50% +32%, +21%
Bortezomib (MM, MCL, 2003, 12)  $5490 +4% (3) +63% +31%, +16%
Brentuximab (lymphoma, 2011, 4)  $19,482 +8% (0.1) +35% +29%, +22%
Clofarabine (ALL, 2004, 11)  $56,486 +3% (3) +31% +8%, -4%
Liposomal vincristine (ALL, 2012, 3)  $34,602 +8% (0.5) +21% +18%, +14%
Nelarabine (ALL, lymphoma, 2005, 10)  $18,513 +6% (2) +83% +55%, +39%
Ofatumumab (CLL, 2009, 6)  $4538 +3% (2) +17% +8%, -0.5%
Pralatrexate (lymphoma, 2009, 6)  $31,684 +6% (4) +43% +31%, +21%
Rituximab (NHL, CLL, 1997, 12)  $4111 +5% (0.5) +85% +49%, +32%

Abbreviations: ALL, acute lymphoblastic leukemia; APL, acute promyelocytic leukemia; CLL, chronic lymphocytic leukemia; MCL, mantle cell lymphoma; MM, multiple myeloma; NHL, non-Hodgkin lymphoma; SD, standard deviation.

The researchers noted that there was a steady increase in drug costs over the study period, regardless of whether a drug was granted a new supplemental indication, the drug had a new off-label indication, or a competitor drug was approved.

The only variable that was significantly associated with price change was the amount of time that had elapsed from a drug’s launch.

This association was significant in models in which the researchers used prices adjusted to inflation (P=0.002) and health-related inflation (P=0.023). However, it was not significant when the researchers used the actual drug price (P=0.085).

*Data in the abstract differ from data in the body of the JCO paper. This article includes data from the body of the JCO paper.

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Rib fracture diagnosis in the panscan era

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Clinical question: Do rib fractures observed on chest CT carry the same morbidity and mortality risk as those observed in chest radiograph?

Background: Traditionally studies have shown that first and second rib fractures on chest radiograph after blunt trauma are associated with substantial morbidity and mortality. With growing frequency of CT imaging in the “panscan” era, it is unknown whether similar rib fractures found on CT carry the same meaning.

Study design: Secondary analysis of two prospective observational studies.

Setting: 10 level I trauma centers.

Synopsis: Data from the National Emergency X-Radiography Utilization Study showed that, of the 8,661 patients who suffered blunt trauma and received both chest radiograph and chest CT, 23.9% had rib fractures. Rib fractures were observed in 66.1% of chest CT–only cases. Patients with rib fractures had a higher admission rate (88.7% versus 45.8%) and higher mortality (5.6% versus 2.7%) than patients without rib fractures. Mortality rate and great-vessel injury were higher in those with first or second rib fractures. The mortality of patients with rib fractures observed only on chest CT was not statistically different from those whose fractures were also seen in chest radiograph. The study included patients who were more severely injured and may have been more likely to receive a CT, which may have led to an overestimation of fractures found. The actual causes of admission and death were not reviewed.

Bottom line: CT in trauma-imaging protocol can identify patients with rib fractures well, compared with combined CT with chest radiograph. Rib fractures are associated with higher rates of admission and mortality risk than those without rib fractures. Specifically, first or second rib fractures are found to have greater risk for mortality and great-vessel injury.

Citation: Murphy CE 4th, Raja AS, Baumann BM, et al. Rib fracture diagnosis in the panscan era. Ann Emerg Med. 2017. doi: 10.1016/j.annemergmed.2017.04.011.

Dr. Xu is assistant professor and hospitalist, Icahn School of Medicine of the Mount Sinai Health System, New York.
 

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Clinical question: Do rib fractures observed on chest CT carry the same morbidity and mortality risk as those observed in chest radiograph?

Background: Traditionally studies have shown that first and second rib fractures on chest radiograph after blunt trauma are associated with substantial morbidity and mortality. With growing frequency of CT imaging in the “panscan” era, it is unknown whether similar rib fractures found on CT carry the same meaning.

Study design: Secondary analysis of two prospective observational studies.

Setting: 10 level I trauma centers.

Synopsis: Data from the National Emergency X-Radiography Utilization Study showed that, of the 8,661 patients who suffered blunt trauma and received both chest radiograph and chest CT, 23.9% had rib fractures. Rib fractures were observed in 66.1% of chest CT–only cases. Patients with rib fractures had a higher admission rate (88.7% versus 45.8%) and higher mortality (5.6% versus 2.7%) than patients without rib fractures. Mortality rate and great-vessel injury were higher in those with first or second rib fractures. The mortality of patients with rib fractures observed only on chest CT was not statistically different from those whose fractures were also seen in chest radiograph. The study included patients who were more severely injured and may have been more likely to receive a CT, which may have led to an overestimation of fractures found. The actual causes of admission and death were not reviewed.

Bottom line: CT in trauma-imaging protocol can identify patients with rib fractures well, compared with combined CT with chest radiograph. Rib fractures are associated with higher rates of admission and mortality risk than those without rib fractures. Specifically, first or second rib fractures are found to have greater risk for mortality and great-vessel injury.

Citation: Murphy CE 4th, Raja AS, Baumann BM, et al. Rib fracture diagnosis in the panscan era. Ann Emerg Med. 2017. doi: 10.1016/j.annemergmed.2017.04.011.

Dr. Xu is assistant professor and hospitalist, Icahn School of Medicine of the Mount Sinai Health System, New York.
 

 

Clinical question: Do rib fractures observed on chest CT carry the same morbidity and mortality risk as those observed in chest radiograph?

Background: Traditionally studies have shown that first and second rib fractures on chest radiograph after blunt trauma are associated with substantial morbidity and mortality. With growing frequency of CT imaging in the “panscan” era, it is unknown whether similar rib fractures found on CT carry the same meaning.

Study design: Secondary analysis of two prospective observational studies.

Setting: 10 level I trauma centers.

Synopsis: Data from the National Emergency X-Radiography Utilization Study showed that, of the 8,661 patients who suffered blunt trauma and received both chest radiograph and chest CT, 23.9% had rib fractures. Rib fractures were observed in 66.1% of chest CT–only cases. Patients with rib fractures had a higher admission rate (88.7% versus 45.8%) and higher mortality (5.6% versus 2.7%) than patients without rib fractures. Mortality rate and great-vessel injury were higher in those with first or second rib fractures. The mortality of patients with rib fractures observed only on chest CT was not statistically different from those whose fractures were also seen in chest radiograph. The study included patients who were more severely injured and may have been more likely to receive a CT, which may have led to an overestimation of fractures found. The actual causes of admission and death were not reviewed.

Bottom line: CT in trauma-imaging protocol can identify patients with rib fractures well, compared with combined CT with chest radiograph. Rib fractures are associated with higher rates of admission and mortality risk than those without rib fractures. Specifically, first or second rib fractures are found to have greater risk for mortality and great-vessel injury.

Citation: Murphy CE 4th, Raja AS, Baumann BM, et al. Rib fracture diagnosis in the panscan era. Ann Emerg Med. 2017. doi: 10.1016/j.annemergmed.2017.04.011.

Dr. Xu is assistant professor and hospitalist, Icahn School of Medicine of the Mount Sinai Health System, New York.
 

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The Tempest Within

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On the heels of Hurricane Harvey, which devastated the city of Houston and other communities in Texas and Louisiana, Hurricane Irma ravaged several islands in the Caribbean—and then headed for the states. In the days before she made landfall in the US, the media offered seemingly minute-to-minute updates on her progress. Each new forecast seemed to contradict the previous, demonstrating the unpredictability of natural disasters. But as the hurricane crept closer, one thing was evident: Florida was going to take a hard hit.

Keeping up with the fluctuating weather report was like watching a tennis match: East Coast … nope, not the East Coast … probably the middle of the state. We breathed periodic sighs of relief but remained leery. Then, several of the spaghetti plots (may I never hear that term again!) showed Irma veering west—right over our heads. Hysteria set in. One meteorologist sounded absolutely frantic as she warned people to GET READY!!!!

Now, to be clear: My purpose in writing is not to disparage media coverage or governmental response, nor to minimize anyone else’s struggles. Rather, I want to share how the hurricane affected my neighbors, friends, family, and myself—and continues to do so, weeks afterward.

Once Irma’s course was set, we swept into action. Our emergency plan included hurricane-proofing our home—protective awnings placed over the windows; outside decorations put away; grill stored properly; palm trees trimmed—and laying in sufficient supplies (gallon jugs of water, needed medications, bread and peanut butter). We gathered important documents, filled the car with gas, and made sure to have cash on hand. This flurry of activity got the adrenaline pumping, but there was something satisfying about checking off each item on our list. Before you knew it, we were set.

Then Governor Scott took the proactive step of declaring a state of emergency, before Irma was even in striking distance. This was beneficial for all Floridians, since it positioned us to receive federal assistance if needed and allowed local officials to act quickly, without the burden of bureaucracy or red tape.

However, as this news spread, our phones began to ring, buzz, and ping. Friends around the country wanted to know, “Are you okay?” and to offer us a place to stay if we needed to get out. These well-intentioned messages were appreciated—but each expression of concern reminded us that we were facing something big. We were fine, though. Prepared. And the storm could still bypass us or at least hit in a weakened state.

As Irma moved closer, the nervous energy in our little community began to rise. Some neighbors headed north several days before the predicted arrival, spending hours in traffic. We were glad we’d decided to shelter in place instead! Our decision was met with worried looks and wringing hands, which perplexed us. After all, we live about two miles from the Gulf of Mexico and 40-plus feet above sea level. My parents had moved to the area in 1978, and Dad always told us it was where people evacuated to, not from. No problem!

Except … then the mandatory evacuation notice was given. Uh oh! Time to revisit our “shelter in place” plan. What were the options again?

Plan A: Call a friend who lives three towns away in a non-evacuation zone. But her daughter gets evacuated every storm, so she, her husband, and their three dogs had already claimed the guest room.

Plan B: Call another friend in the next town over. She was happy to accommodate us! We planned to arrive the night before the predicted hit and wait out the storm there. The plan was foolproof ... until she also got a mandatory evacuation notice.

Plan C: Find a hotel in a safe area. No luck—all booked.

 

 

 

Admittedly, with each snag in our plans, our stress and anxiety increased. We began to question our initial decision to stay put. Had we missed our opportunity to get out of town?

Then, thankfully, the phone rang. Our friend’s daughter had miraculously secured us hotel rooms about 30 miles from our home.

The strangest thing about riding out a hurricane is that you have days of anticipation and action—you prepare—and then you just have to wait. In the confines of our “bunker,” we had naught to do but track the storm. For three days, local television stations aired only the weather; there was no respite from the red tracking markers. The endless barrage of information added to our already heightened stress levels. We wondered what we would face once we returned home. The thought of major damage sickened us.

Three days after Irma visited, we were cleared to head home. We were admittedly nervous to see what she had left behind—but incredibly, we found our house exactly as we had left it. We hugged each other, in tears. The surrounding damage ranged from minor to major, but thankfully, no one was injured. Neighbors who had fled town asked us to send pictures of their homes so they could see for themselves. The consensus: What was broken can be fixed; we are all thankful to have survived. In a way, I expected that to be the end of the story. But I was wrong.

In my February 2010 editorial, I addressed the aftermath of the earthquake that had struck Haiti the month before.1 Seven years later, 2.5 million Haitians are still in need of humanitarian aid, and 55,000 people are in camps and makeshift camps.2 You might be thinking, “An earthquake in Haiti is much different from a hurricane in the United States.” That may be true, but some victims of Hurricane Sandy are still trying to repair damage to their homes, five years later.3 So while Hurricanes Irma and Harvey—let alone Hurricane Sandy—are already off the front pages, the despair, emotional impact, and disbelief associated with the disasters endure. As one woman described, “You’re in complete shock. You’re trying to figure out, ‘Is this happening to me? Am I in some sort of dream I can’t wake up from?’”3

We are not people who are easily discouraged or quick to worry about things we can’t control. But this experience was very different: The sensory overload was unnerving, and the anxiety and stress linger. As a result, I have an entirely new perspective on the effect of disaster on mental health. The worst we suffered was four days without power, yet as I write this weeks later, I find myself in tears, reliving the fear and anxiety we felt during Irma’s wrath. We were ready for a hurricane, but not for the emotional turmoil that has followed.

Have you experienced a disaster, natural or otherwise, that left you shaken? Share your experience, and any advice you may have, with me at [email protected].

References

1. Onieal ME. When helping hands are tied. Clinician Reviews. 2010;20(2):C2, 18-20.
2. Cook J. 7 years after Haiti’s earthquake, millions still need aid. www.huffingtonpost.com/entry/haiti-earthquake-anniversary_us_5875108de4b02b5f858b3f9c. Accessed October 6, 2017.
3. Sandoval E, Marcius CR, Durkin E, Dillon N. Hurricane Sandy victims’ homes still uninhabitable nearly five years later. www.nydailynews.com/new-york/hurricane-sandy-victims-living-limbo-years-article-1.3463866. Accessed October 6, 2017.

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On the heels of Hurricane Harvey, which devastated the city of Houston and other communities in Texas and Louisiana, Hurricane Irma ravaged several islands in the Caribbean—and then headed for the states. In the days before she made landfall in the US, the media offered seemingly minute-to-minute updates on her progress. Each new forecast seemed to contradict the previous, demonstrating the unpredictability of natural disasters. But as the hurricane crept closer, one thing was evident: Florida was going to take a hard hit.

Keeping up with the fluctuating weather report was like watching a tennis match: East Coast … nope, not the East Coast … probably the middle of the state. We breathed periodic sighs of relief but remained leery. Then, several of the spaghetti plots (may I never hear that term again!) showed Irma veering west—right over our heads. Hysteria set in. One meteorologist sounded absolutely frantic as she warned people to GET READY!!!!

Now, to be clear: My purpose in writing is not to disparage media coverage or governmental response, nor to minimize anyone else’s struggles. Rather, I want to share how the hurricane affected my neighbors, friends, family, and myself—and continues to do so, weeks afterward.

Once Irma’s course was set, we swept into action. Our emergency plan included hurricane-proofing our home—protective awnings placed over the windows; outside decorations put away; grill stored properly; palm trees trimmed—and laying in sufficient supplies (gallon jugs of water, needed medications, bread and peanut butter). We gathered important documents, filled the car with gas, and made sure to have cash on hand. This flurry of activity got the adrenaline pumping, but there was something satisfying about checking off each item on our list. Before you knew it, we were set.

Then Governor Scott took the proactive step of declaring a state of emergency, before Irma was even in striking distance. This was beneficial for all Floridians, since it positioned us to receive federal assistance if needed and allowed local officials to act quickly, without the burden of bureaucracy or red tape.

However, as this news spread, our phones began to ring, buzz, and ping. Friends around the country wanted to know, “Are you okay?” and to offer us a place to stay if we needed to get out. These well-intentioned messages were appreciated—but each expression of concern reminded us that we were facing something big. We were fine, though. Prepared. And the storm could still bypass us or at least hit in a weakened state.

As Irma moved closer, the nervous energy in our little community began to rise. Some neighbors headed north several days before the predicted arrival, spending hours in traffic. We were glad we’d decided to shelter in place instead! Our decision was met with worried looks and wringing hands, which perplexed us. After all, we live about two miles from the Gulf of Mexico and 40-plus feet above sea level. My parents had moved to the area in 1978, and Dad always told us it was where people evacuated to, not from. No problem!

Except … then the mandatory evacuation notice was given. Uh oh! Time to revisit our “shelter in place” plan. What were the options again?

Plan A: Call a friend who lives three towns away in a non-evacuation zone. But her daughter gets evacuated every storm, so she, her husband, and their three dogs had already claimed the guest room.

Plan B: Call another friend in the next town over. She was happy to accommodate us! We planned to arrive the night before the predicted hit and wait out the storm there. The plan was foolproof ... until she also got a mandatory evacuation notice.

Plan C: Find a hotel in a safe area. No luck—all booked.

 

 

 

Admittedly, with each snag in our plans, our stress and anxiety increased. We began to question our initial decision to stay put. Had we missed our opportunity to get out of town?

Then, thankfully, the phone rang. Our friend’s daughter had miraculously secured us hotel rooms about 30 miles from our home.

The strangest thing about riding out a hurricane is that you have days of anticipation and action—you prepare—and then you just have to wait. In the confines of our “bunker,” we had naught to do but track the storm. For three days, local television stations aired only the weather; there was no respite from the red tracking markers. The endless barrage of information added to our already heightened stress levels. We wondered what we would face once we returned home. The thought of major damage sickened us.

Three days after Irma visited, we were cleared to head home. We were admittedly nervous to see what she had left behind—but incredibly, we found our house exactly as we had left it. We hugged each other, in tears. The surrounding damage ranged from minor to major, but thankfully, no one was injured. Neighbors who had fled town asked us to send pictures of their homes so they could see for themselves. The consensus: What was broken can be fixed; we are all thankful to have survived. In a way, I expected that to be the end of the story. But I was wrong.

In my February 2010 editorial, I addressed the aftermath of the earthquake that had struck Haiti the month before.1 Seven years later, 2.5 million Haitians are still in need of humanitarian aid, and 55,000 people are in camps and makeshift camps.2 You might be thinking, “An earthquake in Haiti is much different from a hurricane in the United States.” That may be true, but some victims of Hurricane Sandy are still trying to repair damage to their homes, five years later.3 So while Hurricanes Irma and Harvey—let alone Hurricane Sandy—are already off the front pages, the despair, emotional impact, and disbelief associated with the disasters endure. As one woman described, “You’re in complete shock. You’re trying to figure out, ‘Is this happening to me? Am I in some sort of dream I can’t wake up from?’”3

We are not people who are easily discouraged or quick to worry about things we can’t control. But this experience was very different: The sensory overload was unnerving, and the anxiety and stress linger. As a result, I have an entirely new perspective on the effect of disaster on mental health. The worst we suffered was four days without power, yet as I write this weeks later, I find myself in tears, reliving the fear and anxiety we felt during Irma’s wrath. We were ready for a hurricane, but not for the emotional turmoil that has followed.

Have you experienced a disaster, natural or otherwise, that left you shaken? Share your experience, and any advice you may have, with me at [email protected].

 

On the heels of Hurricane Harvey, which devastated the city of Houston and other communities in Texas and Louisiana, Hurricane Irma ravaged several islands in the Caribbean—and then headed for the states. In the days before she made landfall in the US, the media offered seemingly minute-to-minute updates on her progress. Each new forecast seemed to contradict the previous, demonstrating the unpredictability of natural disasters. But as the hurricane crept closer, one thing was evident: Florida was going to take a hard hit.

Keeping up with the fluctuating weather report was like watching a tennis match: East Coast … nope, not the East Coast … probably the middle of the state. We breathed periodic sighs of relief but remained leery. Then, several of the spaghetti plots (may I never hear that term again!) showed Irma veering west—right over our heads. Hysteria set in. One meteorologist sounded absolutely frantic as she warned people to GET READY!!!!

Now, to be clear: My purpose in writing is not to disparage media coverage or governmental response, nor to minimize anyone else’s struggles. Rather, I want to share how the hurricane affected my neighbors, friends, family, and myself—and continues to do so, weeks afterward.

Once Irma’s course was set, we swept into action. Our emergency plan included hurricane-proofing our home—protective awnings placed over the windows; outside decorations put away; grill stored properly; palm trees trimmed—and laying in sufficient supplies (gallon jugs of water, needed medications, bread and peanut butter). We gathered important documents, filled the car with gas, and made sure to have cash on hand. This flurry of activity got the adrenaline pumping, but there was something satisfying about checking off each item on our list. Before you knew it, we were set.

Then Governor Scott took the proactive step of declaring a state of emergency, before Irma was even in striking distance. This was beneficial for all Floridians, since it positioned us to receive federal assistance if needed and allowed local officials to act quickly, without the burden of bureaucracy or red tape.

However, as this news spread, our phones began to ring, buzz, and ping. Friends around the country wanted to know, “Are you okay?” and to offer us a place to stay if we needed to get out. These well-intentioned messages were appreciated—but each expression of concern reminded us that we were facing something big. We were fine, though. Prepared. And the storm could still bypass us or at least hit in a weakened state.

As Irma moved closer, the nervous energy in our little community began to rise. Some neighbors headed north several days before the predicted arrival, spending hours in traffic. We were glad we’d decided to shelter in place instead! Our decision was met with worried looks and wringing hands, which perplexed us. After all, we live about two miles from the Gulf of Mexico and 40-plus feet above sea level. My parents had moved to the area in 1978, and Dad always told us it was where people evacuated to, not from. No problem!

Except … then the mandatory evacuation notice was given. Uh oh! Time to revisit our “shelter in place” plan. What were the options again?

Plan A: Call a friend who lives three towns away in a non-evacuation zone. But her daughter gets evacuated every storm, so she, her husband, and their three dogs had already claimed the guest room.

Plan B: Call another friend in the next town over. She was happy to accommodate us! We planned to arrive the night before the predicted hit and wait out the storm there. The plan was foolproof ... until she also got a mandatory evacuation notice.

Plan C: Find a hotel in a safe area. No luck—all booked.

 

 

 

Admittedly, with each snag in our plans, our stress and anxiety increased. We began to question our initial decision to stay put. Had we missed our opportunity to get out of town?

Then, thankfully, the phone rang. Our friend’s daughter had miraculously secured us hotel rooms about 30 miles from our home.

The strangest thing about riding out a hurricane is that you have days of anticipation and action—you prepare—and then you just have to wait. In the confines of our “bunker,” we had naught to do but track the storm. For three days, local television stations aired only the weather; there was no respite from the red tracking markers. The endless barrage of information added to our already heightened stress levels. We wondered what we would face once we returned home. The thought of major damage sickened us.

Three days after Irma visited, we were cleared to head home. We were admittedly nervous to see what she had left behind—but incredibly, we found our house exactly as we had left it. We hugged each other, in tears. The surrounding damage ranged from minor to major, but thankfully, no one was injured. Neighbors who had fled town asked us to send pictures of their homes so they could see for themselves. The consensus: What was broken can be fixed; we are all thankful to have survived. In a way, I expected that to be the end of the story. But I was wrong.

In my February 2010 editorial, I addressed the aftermath of the earthquake that had struck Haiti the month before.1 Seven years later, 2.5 million Haitians are still in need of humanitarian aid, and 55,000 people are in camps and makeshift camps.2 You might be thinking, “An earthquake in Haiti is much different from a hurricane in the United States.” That may be true, but some victims of Hurricane Sandy are still trying to repair damage to their homes, five years later.3 So while Hurricanes Irma and Harvey—let alone Hurricane Sandy—are already off the front pages, the despair, emotional impact, and disbelief associated with the disasters endure. As one woman described, “You’re in complete shock. You’re trying to figure out, ‘Is this happening to me? Am I in some sort of dream I can’t wake up from?’”3

We are not people who are easily discouraged or quick to worry about things we can’t control. But this experience was very different: The sensory overload was unnerving, and the anxiety and stress linger. As a result, I have an entirely new perspective on the effect of disaster on mental health. The worst we suffered was four days without power, yet as I write this weeks later, I find myself in tears, reliving the fear and anxiety we felt during Irma’s wrath. We were ready for a hurricane, but not for the emotional turmoil that has followed.

Have you experienced a disaster, natural or otherwise, that left you shaken? Share your experience, and any advice you may have, with me at [email protected].

References

1. Onieal ME. When helping hands are tied. Clinician Reviews. 2010;20(2):C2, 18-20.
2. Cook J. 7 years after Haiti’s earthquake, millions still need aid. www.huffingtonpost.com/entry/haiti-earthquake-anniversary_us_5875108de4b02b5f858b3f9c. Accessed October 6, 2017.
3. Sandoval E, Marcius CR, Durkin E, Dillon N. Hurricane Sandy victims’ homes still uninhabitable nearly five years later. www.nydailynews.com/new-york/hurricane-sandy-victims-living-limbo-years-article-1.3463866. Accessed October 6, 2017.

References

1. Onieal ME. When helping hands are tied. Clinician Reviews. 2010;20(2):C2, 18-20.
2. Cook J. 7 years after Haiti’s earthquake, millions still need aid. www.huffingtonpost.com/entry/haiti-earthquake-anniversary_us_5875108de4b02b5f858b3f9c. Accessed October 6, 2017.
3. Sandoval E, Marcius CR, Durkin E, Dillon N. Hurricane Sandy victims’ homes still uninhabitable nearly five years later. www.nydailynews.com/new-york/hurricane-sandy-victims-living-limbo-years-article-1.3463866. Accessed October 6, 2017.

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New, persistent opioid use more common after bariatric surgery

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– Bariatric patients are nearly 50% more likely than general surgery patients to start using opioids after their procedures and continue taking the painkillers for a year, a new study finds.

It’s not clear why bariatric patients are at higher risk of continued opioid use, nor whether they are more likely to become addicted. Still, bariatric patients are a target for “intervention, enhanced education, early referral to specialists, protocols minimizing inpatient and outpatient narcotics, opioid-free operations, system-based interventions and prescribing guidelines,” says study lead author Sanjay Mohanty, MD, a surgery resident with the Henry Ford Health System, who spoke in a presentation at the annual clinical congress of the American College of Surgeons.

There’s been little research into opioid use among bariatric patients, said Dr. Mohanty. In 2013, a retrospective study found that 8% of 11,719 bariatric patients were chronic opioid users, and more than three-quarters of those remained so after 1 year. However, that study was completed in 2010 before the height of the opioid epidemic (JAMA. 2013;310(13):1369-76).

More recently, a 2017 study found that opioid use among 1,892 bariatric patients who weren’t using at baseline grew from 5.8% at 6 months to 14.2% at 7 years. The study tracked patients until January 2015 (Surg Obes Relat Dis. 2017 Aug;13 (8):1337-46).

Dr. Arthur Carlin
Opioid use after bariatric procedures is common, said the current study co-author Arthur M. Carlin, MD, FACS, FASMBS, vice-chairman of the Department of Surgery and division head of General Surgery with Henry Ford Health System, who spoke in an interview. Dr. Carlin, who’s also professor of Surgery at Wayne State University School of Medicine, said that he’s seen patients routinely take morphine via self-controlled drip in the hospital and be prescribed 20-30 pills to take home.

For the new study, researchers tracked 14,063 bariatric patients in the Michigan Bariatric Surgery Collaborative, a group of Michigan hospitals and health systems, from 2006-2017.

Of the patients, 73% were opioid-naive at baseline and 27% were users. At 1 year after procedure, overall use dropped slightly to 24%. However, 905 patients – 8.8% of the initial opioid-native group – were new and persistent opioid users.

According to Dr. Carlin, this is almost 50% higher than in patients after general surgical procedures.

These users were significantly more likely to be black (OR 1.67), less likely to have private insurance (0.76 OR), more likely to have income under $25,000 (OR 1.43), and more likely to have a mobility limitation (OR 1.78).

The researchers also found evidence linking a higher risk of new and persistent opioid use to lack of unemployment, depression, musculoskeletal disorders, tobacco use and gastric bypass procedures.

Why might bariatric patients in general be more susceptible to new and persistent opioid use? “We don’t know that answer,” Dr. Carlin said. “Maybe there’s some addiction transfer. Or maybe it’s something physiologic. We’re doing an operation on the gut, and that could have an impact on absorption.”

As for solutions, Dr. Carlin says “prescribe less, prescribe differently, be more patient-specific. We’re looking at different modalities to treat the pain such as nerve blocks during surgery, anti-inflammatories and muscle relaxants.”

And if patients aren’t using opioids in the hospital and not having that much pain, he said, physicians don’t send any pills home with them.

The next steps should include research into links between opioids and perioperative complications and surgical outcomes, the researchers suggested.

Dr. Carlin and Dr. Mohanty report no relevant disclosures.
 

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– Bariatric patients are nearly 50% more likely than general surgery patients to start using opioids after their procedures and continue taking the painkillers for a year, a new study finds.

It’s not clear why bariatric patients are at higher risk of continued opioid use, nor whether they are more likely to become addicted. Still, bariatric patients are a target for “intervention, enhanced education, early referral to specialists, protocols minimizing inpatient and outpatient narcotics, opioid-free operations, system-based interventions and prescribing guidelines,” says study lead author Sanjay Mohanty, MD, a surgery resident with the Henry Ford Health System, who spoke in a presentation at the annual clinical congress of the American College of Surgeons.

There’s been little research into opioid use among bariatric patients, said Dr. Mohanty. In 2013, a retrospective study found that 8% of 11,719 bariatric patients were chronic opioid users, and more than three-quarters of those remained so after 1 year. However, that study was completed in 2010 before the height of the opioid epidemic (JAMA. 2013;310(13):1369-76).

More recently, a 2017 study found that opioid use among 1,892 bariatric patients who weren’t using at baseline grew from 5.8% at 6 months to 14.2% at 7 years. The study tracked patients until January 2015 (Surg Obes Relat Dis. 2017 Aug;13 (8):1337-46).

Dr. Arthur Carlin
Opioid use after bariatric procedures is common, said the current study co-author Arthur M. Carlin, MD, FACS, FASMBS, vice-chairman of the Department of Surgery and division head of General Surgery with Henry Ford Health System, who spoke in an interview. Dr. Carlin, who’s also professor of Surgery at Wayne State University School of Medicine, said that he’s seen patients routinely take morphine via self-controlled drip in the hospital and be prescribed 20-30 pills to take home.

For the new study, researchers tracked 14,063 bariatric patients in the Michigan Bariatric Surgery Collaborative, a group of Michigan hospitals and health systems, from 2006-2017.

Of the patients, 73% were opioid-naive at baseline and 27% were users. At 1 year after procedure, overall use dropped slightly to 24%. However, 905 patients – 8.8% of the initial opioid-native group – were new and persistent opioid users.

According to Dr. Carlin, this is almost 50% higher than in patients after general surgical procedures.

These users were significantly more likely to be black (OR 1.67), less likely to have private insurance (0.76 OR), more likely to have income under $25,000 (OR 1.43), and more likely to have a mobility limitation (OR 1.78).

The researchers also found evidence linking a higher risk of new and persistent opioid use to lack of unemployment, depression, musculoskeletal disorders, tobacco use and gastric bypass procedures.

Why might bariatric patients in general be more susceptible to new and persistent opioid use? “We don’t know that answer,” Dr. Carlin said. “Maybe there’s some addiction transfer. Or maybe it’s something physiologic. We’re doing an operation on the gut, and that could have an impact on absorption.”

As for solutions, Dr. Carlin says “prescribe less, prescribe differently, be more patient-specific. We’re looking at different modalities to treat the pain such as nerve blocks during surgery, anti-inflammatories and muscle relaxants.”

And if patients aren’t using opioids in the hospital and not having that much pain, he said, physicians don’t send any pills home with them.

The next steps should include research into links between opioids and perioperative complications and surgical outcomes, the researchers suggested.

Dr. Carlin and Dr. Mohanty report no relevant disclosures.
 

 

– Bariatric patients are nearly 50% more likely than general surgery patients to start using opioids after their procedures and continue taking the painkillers for a year, a new study finds.

It’s not clear why bariatric patients are at higher risk of continued opioid use, nor whether they are more likely to become addicted. Still, bariatric patients are a target for “intervention, enhanced education, early referral to specialists, protocols minimizing inpatient and outpatient narcotics, opioid-free operations, system-based interventions and prescribing guidelines,” says study lead author Sanjay Mohanty, MD, a surgery resident with the Henry Ford Health System, who spoke in a presentation at the annual clinical congress of the American College of Surgeons.

There’s been little research into opioid use among bariatric patients, said Dr. Mohanty. In 2013, a retrospective study found that 8% of 11,719 bariatric patients were chronic opioid users, and more than three-quarters of those remained so after 1 year. However, that study was completed in 2010 before the height of the opioid epidemic (JAMA. 2013;310(13):1369-76).

More recently, a 2017 study found that opioid use among 1,892 bariatric patients who weren’t using at baseline grew from 5.8% at 6 months to 14.2% at 7 years. The study tracked patients until January 2015 (Surg Obes Relat Dis. 2017 Aug;13 (8):1337-46).

Dr. Arthur Carlin
Opioid use after bariatric procedures is common, said the current study co-author Arthur M. Carlin, MD, FACS, FASMBS, vice-chairman of the Department of Surgery and division head of General Surgery with Henry Ford Health System, who spoke in an interview. Dr. Carlin, who’s also professor of Surgery at Wayne State University School of Medicine, said that he’s seen patients routinely take morphine via self-controlled drip in the hospital and be prescribed 20-30 pills to take home.

For the new study, researchers tracked 14,063 bariatric patients in the Michigan Bariatric Surgery Collaborative, a group of Michigan hospitals and health systems, from 2006-2017.

Of the patients, 73% were opioid-naive at baseline and 27% were users. At 1 year after procedure, overall use dropped slightly to 24%. However, 905 patients – 8.8% of the initial opioid-native group – were new and persistent opioid users.

According to Dr. Carlin, this is almost 50% higher than in patients after general surgical procedures.

These users were significantly more likely to be black (OR 1.67), less likely to have private insurance (0.76 OR), more likely to have income under $25,000 (OR 1.43), and more likely to have a mobility limitation (OR 1.78).

The researchers also found evidence linking a higher risk of new and persistent opioid use to lack of unemployment, depression, musculoskeletal disorders, tobacco use and gastric bypass procedures.

Why might bariatric patients in general be more susceptible to new and persistent opioid use? “We don’t know that answer,” Dr. Carlin said. “Maybe there’s some addiction transfer. Or maybe it’s something physiologic. We’re doing an operation on the gut, and that could have an impact on absorption.”

As for solutions, Dr. Carlin says “prescribe less, prescribe differently, be more patient-specific. We’re looking at different modalities to treat the pain such as nerve blocks during surgery, anti-inflammatories and muscle relaxants.”

And if patients aren’t using opioids in the hospital and not having that much pain, he said, physicians don’t send any pills home with them.

The next steps should include research into links between opioids and perioperative complications and surgical outcomes, the researchers suggested.

Dr. Carlin and Dr. Mohanty report no relevant disclosures.
 

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Key clinical point: It’s common for opioid-naive bariatric patients to begin using opioids after surgery and continuing at 1 year.

Major finding: At 1 year after surgery, 8.8% of the 73% of bariatric patients who were opioid-naive were new and persistent opioid users.

Data source: 14,063 Michigan bariatric patients tracked from 2006-2017.

Disclosures: The study authors report no relevant disclosures.

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FDA grants 510k clearance for glucose monitoring system

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OptiScan Biomedical Corporation announced Oct. 18 that the Food and Drug Administration has granted 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System.

The clearance allows the device to be used for monitoring plasma glucose levels and determining dysglycemia in surgical intensive care unit (SICU) patients. It is a bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.

In a multi-center clinical trial in 160 surgical intensive care unit patients, results found the OptiScanner 5000 to be safe and accurate for use in patients in the SICU. The study results also showed the ability of the device to combine accurate plasma glucose measurement with the convenience of continuous, real-time bedside monitoring, and alarms which notify clinicians of excursions from the desired glucose range.

It is estimated that roughly 20% of ICU patients have pre-existing diabetes and an additional 40- to- 60% of ICU patients suffer from “stress hyperglycemia” or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control.

“There is a broad consensus in the medical community regarding the need for automated, continuous and highly accurate glucose monitoring in the ICU and my experience with the OptiScanner 5000 indicates that this device will play a critical role in delivering this enhanced level of care. I look forward to implementing this technology as soon as possible,” said Grant V. Bochicchio, MD, MPH, FACS, chief of acute and critical care surgery, and Harry Edison Professor of Surgery, Washington University School of Medicine, in a press release.

Read the full press release here.

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OptiScan Biomedical Corporation announced Oct. 18 that the Food and Drug Administration has granted 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System.

The clearance allows the device to be used for monitoring plasma glucose levels and determining dysglycemia in surgical intensive care unit (SICU) patients. It is a bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.

In a multi-center clinical trial in 160 surgical intensive care unit patients, results found the OptiScanner 5000 to be safe and accurate for use in patients in the SICU. The study results also showed the ability of the device to combine accurate plasma glucose measurement with the convenience of continuous, real-time bedside monitoring, and alarms which notify clinicians of excursions from the desired glucose range.

It is estimated that roughly 20% of ICU patients have pre-existing diabetes and an additional 40- to- 60% of ICU patients suffer from “stress hyperglycemia” or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control.

“There is a broad consensus in the medical community regarding the need for automated, continuous and highly accurate glucose monitoring in the ICU and my experience with the OptiScanner 5000 indicates that this device will play a critical role in delivering this enhanced level of care. I look forward to implementing this technology as soon as possible,” said Grant V. Bochicchio, MD, MPH, FACS, chief of acute and critical care surgery, and Harry Edison Professor of Surgery, Washington University School of Medicine, in a press release.

Read the full press release here.

 

OptiScan Biomedical Corporation announced Oct. 18 that the Food and Drug Administration has granted 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System.

The clearance allows the device to be used for monitoring plasma glucose levels and determining dysglycemia in surgical intensive care unit (SICU) patients. It is a bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.

In a multi-center clinical trial in 160 surgical intensive care unit patients, results found the OptiScanner 5000 to be safe and accurate for use in patients in the SICU. The study results also showed the ability of the device to combine accurate plasma glucose measurement with the convenience of continuous, real-time bedside monitoring, and alarms which notify clinicians of excursions from the desired glucose range.

It is estimated that roughly 20% of ICU patients have pre-existing diabetes and an additional 40- to- 60% of ICU patients suffer from “stress hyperglycemia” or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control.

“There is a broad consensus in the medical community regarding the need for automated, continuous and highly accurate glucose monitoring in the ICU and my experience with the OptiScanner 5000 indicates that this device will play a critical role in delivering this enhanced level of care. I look forward to implementing this technology as soon as possible,” said Grant V. Bochicchio, MD, MPH, FACS, chief of acute and critical care surgery, and Harry Edison Professor of Surgery, Washington University School of Medicine, in a press release.

Read the full press release here.

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Type of headwear worn during surgery had no impact on SSI rates

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– Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

Dr. Shanu Kothari
“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

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– Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

Dr. Shanu Kothari
“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

 

– Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

Dr. Shanu Kothari
“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

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Key clinical point: Surgeon preference should dictate choice of headwear in the OR.

Major finding: There was no significant difference in the rate of SSI, regardless of whether a skull cap or a bouffant cap was used during surgery.

Study details: Re-examination of a prospective, randomized non-inferiority trial of 1,543 patients, on the impact of hair removal on surgical site infection rates.

Disclosures: Dr. Kothari reporting having no relevant disclosures.

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