MUNICH – A four-component imaging/biomarker screen was highly accurate for identifying silent myocardial infarction among asymptomatic patients with type 2 diabetes.

The screen is far more accurate than the current standards of invasive imaging or only looking for pathologic Q waves, Peter Swoboda, MD, said at the annual meeting of the European Association for the Study of Diabetes.

“By combining these four factors we came up with a tool that has a diagnostic area under the curve [AUC] of 0.85,” said Dr. Swoboda of Leeds (England) University. “This is far better than the 0.58 AUC that we have with Q waves only – a sensitivity of just 25%.”

The study was published online in June in the Journal of Clinical Endocrinology and Metabolism (JCEM 2016. doi: 10.1210/jc.2016-1318).

The screen employs noninvasive imaging and biomarkers to tap multiple clinical hallmarks of silent MI. The components are:

• electrocardiogram.

• echocardiography.

• biomarker assessment.

• cardiac magnetic resonance imaging, focusing on left ventricular ejection fraction and late gadolinium enhancement.

The study cohort comprised 100 patients with type 2 diabetes without known heart disease and with no new cardiac symptoms. They underwent cardiac MRI, a 12-lead electrocardiogram, echocardiography, and serum biomarker assessment. Late gadolinium enhancement identified evidence of silent MI in 17 patients (17%).

There were few differences in the clinical characteristics of those who had experienced MI and those who had not, Dr. Swoboda noted. There were no differences at all in diabetes-related measures, including disease duration or hemoglobin A_1c levels. Blood pressures were similar. Patients with MI were significantly older (65 vs. 60 years).

In cardiac-specific measures, left ventricular ejection fraction was similar, as was left ventricular mass, end diastolic volume, and left atrial volume. There were however, other very important differences, Dr. Swoboda noted.

Imaging included a measure called “feature tracking analysis,” which measured the peak global longitudinal strain, systolic strain rate, and early and late diastolic strain rates during contraction. This analysis noted a significant difference in global longitudinal strain between the MI and non-MI groups.

Ventricular filling velocities as measured by the E/A ratio on ECG were also significantly different between the MI and non-MI groups (0.75 vs. 0.89, respectively). ECG also found pathologic Q waves in significantly more MI patients (24% vs. 7%).

Finally, the serum biomarker panel showed a very strong increase in B-type natriuretic peptide (NT-proBNP) among MI patients, compared with non-MI patients (105 vs. 52 ng/L). There were no significant differences in the other biomarkers, including C-reactive protein and high-sensitive cardiac troponin.

Dr. Swoboda and his team then compiled these findings into a composite measure, assigning them optimum cutoff measures:

• Age older than 62 years.

• E/A ratio 0.72 or lower.

• Global longitudinal strain of at least 18.4%.

• NT-proBNP more than 29 ng/L.

The system resulted in a diagnostic accuracy AUC of 0.85 – significantly better than any of the AUCs generated by the individual components. All patients who scored 0 or 1 were free of MI. Among the 28 with a score of 2, only three had experienced a silent MI. Among the 21 with a score of 3, seven had experienced a silent MI and 14 had not. Among the 16 with a score of 4, seven had experienced a silent MI and nine had not.

While Dr. Swoboda called the screening method “simple” during discussion, a colleague in the audience disagreed with that.

“A simple test is something like a blood test only, not an MRI. Not imaging. That is expensive and takes time,” said Naveed Sattar, MD, of the University of Glasgow, Scotland. “However, I do think your data add more to the evidence that BNP can be a really valuable marker of cardiovascular risk in patients with diabetes.”

Dr. Sattar recently examined the value of cardiac serum biomarkers in predicting cardiovascular disease and mortality in nearly 100,000 people without a history of heart disease. In these subjects, he wrote, “NT-proBNP assessment strongly predicted first-onset heart failure and augmented coronary heart disease and stroke prediction, suggesting that NT-proBNP concentration assessment could be used to integrate heart failure into cardiovascular disease primary prevention.”

The paper appeared online in Lancet Diabetes in September (Lancet Diab. 2016. doi: 10.1016/S2213-8587[16]30196-6).

Dr. Swoboda agreed that data continue to support the increased use of NT-proBNP as a marker of heart disease.

“I think that in the future, diabetes medicine is moving toward individualized patient care, based on individualized risk factors. The future of assessing asymptomatic cardiac patients might be a combination of BNP and MRI.”

Dr. Swoboda had no financial disclosures. Some of Dr. Sattar’s coauthors reported relationships with pharmaceutical companies.

 

[email protected]

MUNICH – A four-component imaging/biomarker screen was highly accurate for identifying silent myocardial infarction among asymptomatic patients with type 2 diabetes.

The screen is far more accurate than the current standards of invasive imaging or only looking for pathologic Q waves, Peter Swoboda, MD, said at the annual meeting of the European Association for the Study of Diabetes.

“By combining these four factors we came up with a tool that has a diagnostic area under the curve [AUC] of 0.85,” said Dr. Swoboda of Leeds (England) University. “This is far better than the 0.58 AUC that we have with Q waves only – a sensitivity of just 25%.”

The study was published online in June in the Journal of Clinical Endocrinology and Metabolism (JCEM 2016. doi: 10.1210/jc.2016-1318).

The screen employs noninvasive imaging and biomarkers to tap multiple clinical hallmarks of silent MI. The components are:

• electrocardiogram.

• echocardiography.

• biomarker assessment.

• cardiac magnetic resonance imaging, focusing on left ventricular ejection fraction and late gadolinium enhancement.

The study cohort comprised 100 patients with type 2 diabetes without known heart disease and with no new cardiac symptoms. They underwent cardiac MRI, a 12-lead electrocardiogram, echocardiography, and serum biomarker assessment. Late gadolinium enhancement identified evidence of silent MI in 17 patients (17%).

There were few differences in the clinical characteristics of those who had experienced MI and those who had not, Dr. Swoboda noted. There were no differences at all in diabetes-related measures, including disease duration or hemoglobin A_1c levels. Blood pressures were similar. Patients with MI were significantly older (65 vs. 60 years).

In cardiac-specific measures, left ventricular ejection fraction was similar, as was left ventricular mass, end diastolic volume, and left atrial volume. There were however, other very important differences, Dr. Swoboda noted.

Imaging included a measure called “feature tracking analysis,” which measured the peak global longitudinal strain, systolic strain rate, and early and late diastolic strain rates during contraction. This analysis noted a significant difference in global longitudinal strain between the MI and non-MI groups.

Ventricular filling velocities as measured by the E/A ratio on ECG were also significantly different between the MI and non-MI groups (0.75 vs. 0.89, respectively). ECG also found pathologic Q waves in significantly more MI patients (24% vs. 7%).

Finally, the serum biomarker panel showed a very strong increase in B-type natriuretic peptide (NT-proBNP) among MI patients, compared with non-MI patients (105 vs. 52 ng/L). There were no significant differences in the other biomarkers, including C-reactive protein and high-sensitive cardiac troponin.

Dr. Swoboda and his team then compiled these findings into a composite measure, assigning them optimum cutoff measures:

• Age older than 62 years.

• E/A ratio 0.72 or lower.

• Global longitudinal strain of at least 18.4%.

• NT-proBNP more than 29 ng/L.

The system resulted in a diagnostic accuracy AUC of 0.85 – significantly better than any of the AUCs generated by the individual components. All patients who scored 0 or 1 were free of MI. Among the 28 with a score of 2, only three had experienced a silent MI. Among the 21 with a score of 3, seven had experienced a silent MI and 14 had not. Among the 16 with a score of 4, seven had experienced a silent MI and nine had not.

While Dr. Swoboda called the screening method “simple” during discussion, a colleague in the audience disagreed with that.

“A simple test is something like a blood test only, not an MRI. Not imaging. That is expensive and takes time,” said Naveed Sattar, MD, of the University of Glasgow, Scotland. “However, I do think your data add more to the evidence that BNP can be a really valuable marker of cardiovascular risk in patients with diabetes.”

Dr. Sattar recently examined the value of cardiac serum biomarkers in predicting cardiovascular disease and mortality in nearly 100,000 people without a history of heart disease. In these subjects, he wrote, “NT-proBNP assessment strongly predicted first-onset heart failure and augmented coronary heart disease and stroke prediction, suggesting that NT-proBNP concentration assessment could be used to integrate heart failure into cardiovascular disease primary prevention.”

The paper appeared online in Lancet Diabetes in September (Lancet Diab. 2016. doi: 10.1016/S2213-8587[16]30196-6).

Dr. Swoboda agreed that data continue to support the increased use of NT-proBNP as a marker of heart disease.

“I think that in the future, diabetes medicine is moving toward individualized patient care, based on individualized risk factors. The future of assessing asymptomatic cardiac patients might be a combination of BNP and MRI.”

Dr. Swoboda had no financial disclosures. Some of Dr. Sattar’s coauthors reported relationships with pharmaceutical companies.

 

[email protected]

MUNICH – A four-component imaging/biomarker screen was highly accurate for identifying silent myocardial infarction among asymptomatic patients with type 2 diabetes.

The screen is far more accurate than the current standards of invasive imaging or only looking for pathologic Q waves, Peter Swoboda, MD, said at the annual meeting of the European Association for the Study of Diabetes.

“By combining these four factors we came up with a tool that has a diagnostic area under the curve [AUC] of 0.85,” said Dr. Swoboda of Leeds (England) University. “This is far better than the 0.58 AUC that we have with Q waves only – a sensitivity of just 25%.”

The study was published online in June in the Journal of Clinical Endocrinology and Metabolism (JCEM 2016. doi: 10.1210/jc.2016-1318).

The screen employs noninvasive imaging and biomarkers to tap multiple clinical hallmarks of silent MI. The components are:

• electrocardiogram.

• echocardiography.

• biomarker assessment.

• cardiac magnetic resonance imaging, focusing on left ventricular ejection fraction and late gadolinium enhancement.

The study cohort comprised 100 patients with type 2 diabetes without known heart disease and with no new cardiac symptoms. They underwent cardiac MRI, a 12-lead electrocardiogram, echocardiography, and serum biomarker assessment. Late gadolinium enhancement identified evidence of silent MI in 17 patients (17%).

There were few differences in the clinical characteristics of those who had experienced MI and those who had not, Dr. Swoboda noted. There were no differences at all in diabetes-related measures, including disease duration or hemoglobin A_1c levels. Blood pressures were similar. Patients with MI were significantly older (65 vs. 60 years).

In cardiac-specific measures, left ventricular ejection fraction was similar, as was left ventricular mass, end diastolic volume, and left atrial volume. There were however, other very important differences, Dr. Swoboda noted.

Imaging included a measure called “feature tracking analysis,” which measured the peak global longitudinal strain, systolic strain rate, and early and late diastolic strain rates during contraction. This analysis noted a significant difference in global longitudinal strain between the MI and non-MI groups.

Ventricular filling velocities as measured by the E/A ratio on ECG were also significantly different between the MI and non-MI groups (0.75 vs. 0.89, respectively). ECG also found pathologic Q waves in significantly more MI patients (24% vs. 7%).

Finally, the serum biomarker panel showed a very strong increase in B-type natriuretic peptide (NT-proBNP) among MI patients, compared with non-MI patients (105 vs. 52 ng/L). There were no significant differences in the other biomarkers, including C-reactive protein and high-sensitive cardiac troponin.

Dr. Swoboda and his team then compiled these findings into a composite measure, assigning them optimum cutoff measures:

• Age older than 62 years.

• E/A ratio 0.72 or lower.

• Global longitudinal strain of at least 18.4%.

• NT-proBNP more than 29 ng/L.

The system resulted in a diagnostic accuracy AUC of 0.85 – significantly better than any of the AUCs generated by the individual components. All patients who scored 0 or 1 were free of MI. Among the 28 with a score of 2, only three had experienced a silent MI. Among the 21 with a score of 3, seven had experienced a silent MI and 14 had not. Among the 16 with a score of 4, seven had experienced a silent MI and nine had not.

While Dr. Swoboda called the screening method “simple” during discussion, a colleague in the audience disagreed with that.

“A simple test is something like a blood test only, not an MRI. Not imaging. That is expensive and takes time,” said Naveed Sattar, MD, of the University of Glasgow, Scotland. “However, I do think your data add more to the evidence that BNP can be a really valuable marker of cardiovascular risk in patients with diabetes.”

Dr. Sattar recently examined the value of cardiac serum biomarkers in predicting cardiovascular disease and mortality in nearly 100,000 people without a history of heart disease. In these subjects, he wrote, “NT-proBNP assessment strongly predicted first-onset heart failure and augmented coronary heart disease and stroke prediction, suggesting that NT-proBNP concentration assessment could be used to integrate heart failure into cardiovascular disease primary prevention.”

The paper appeared online in Lancet Diabetes in September (Lancet Diab. 2016. doi: 10.1016/S2213-8587[16]30196-6).

Dr. Swoboda agreed that data continue to support the increased use of NT-proBNP as a marker of heart disease.

“I think that in the future, diabetes medicine is moving toward individualized patient care, based on individualized risk factors. The future of assessing asymptomatic cardiac patients might be a combination of BNP and MRI.”

Dr. Swoboda had no financial disclosures. Some of Dr. Sattar’s coauthors reported relationships with pharmaceutical companies.

 

[email protected]

The nation’s ongoing opioid problem comes with staggering physical and emotional costs to patients and families. But the dollar cost to the health system has been harder to peg. Now a new report shows a more than 1,300 percent rise in spending by health insurers in a four-year period on patients with a diagnosis of opioid dependence or abuse.

From 2011 to 2015, insurers’ payments to hospitals, laboratories, treatment centers and other medical providers for these patients grew from $32 million to $446 million – a 1,375 percent increase.

While that’s a small portion of the overall spending on medical care in the United States, the rapid rise is cause for concern, says Robin Gelburd, president of Fair Health, a nonprofit databank that provides cost information to the health industry and consumers.

“That really shows the stress on the health system and the impact on the individuals,” said Gelburd.

The Fair Health study found a sharp difference in how much insurers spend on individual patients with such a diagnosis.

On average, insurers spend $3,435 a year on an individual patient, but for those with an opioid dependence or abuse diagnosis, that amount jumps to $19,333. Those numbers reflect what insurers actually paid. The report also includes data on what providers charged, amounts that are lowered by their contracts with insurers.

The study, set to be released Tuesday, builds on one Fair Health released in early August that found a 3,000 percent increase in the volume of insurance claims related to opioid dependence diagnoses between 2007 and 2014.

The latest study – part of a series – offers amounts associated with claims billed by providers and paid by insurers for the types of medical services used.

Both studies use de-identified claims data from insurers representing more than 150 million insured Americans who either have insurance through work or buy coverage on their own.

There have been other efforts by several researchers to quantify the cost of the opioid problem on the overall economy, estimated in the tens of billions of dollars.

The new report adds to the available data “that it’s not just the human cost associated with the opioid crisis that is enormous, but also that the economic costs are staggering,” said Dr. Andrew Kolodny, senior scientist at Brandeis University. He did not work on the study.

The surge in spending on patients with opioid diagnoses is likely a combination of factors, the report notes. As media attention focuses on drug dependency, more people may be seeking treatment. At the same time, prescription and illegal use of narcotics may also be increasing.

The study found that emergency room visits and laboratory tests accounted for much of the spending.

Based on claims volume, the fastest-growing set of services in terms of utilization were for alcohol or drug therapy. Lab tests, including checks for barbiturate or opioid use, were not far behind.

Researchers did not use 2015 data for lab test costs, noting that a change in billing codes was made that increased the number of categories – and, in some cases, appear to generate higher payments by insurers. It is too early to estimate the long-term effects of the change, Gelburd said.

The report gives some examples of the changes, however. For example, one billing code for a test on opiate use commonly brought in a $31 payment from insurers prior to the change. The two billing codes that replaced it now are commonly paid at $78 and $156.

The new billing codes may reflect new technology in testing, said Gelburd. She said some observers speculate that the rapid increase in lab spending might reflect that, with more patients in therapy, the tests are being used to ensure they are taking their proper medications and not abusing narcotics.

But the spending might also reflect a growing use of very expensive urine and blood tests when less expensive ones would be sufficient, said Kolodny.

“I worry about profiteering,” said Kolodny. “We do need tests, but not the expensive ones. A lot of clinics are making extra money off these lab tests.”

The overall increase in spending across all types of medical services “is a societal issue,” said Gelburd, who says policymakers need to ensure that changes are made to address the problem.

“Are medical school curricula adjusting to recognize the growing need for these services? Are insurers increasing the number of providers in their networks to ensure sufficient access? Are consumers being educated? It’s an issue that has to be dealt with in all quadrants.”

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

The nation’s ongoing opioid problem comes with staggering physical and emotional costs to patients and families. But the dollar cost to the health system has been harder to peg. Now a new report shows a more than 1,300 percent rise in spending by health insurers in a four-year period on patients with a diagnosis of opioid dependence or abuse.

From 2011 to 2015, insurers’ payments to hospitals, laboratories, treatment centers and other medical providers for these patients grew from $32 million to $446 million – a 1,375 percent increase.

While that’s a small portion of the overall spending on medical care in the United States, the rapid rise is cause for concern, says Robin Gelburd, president of Fair Health, a nonprofit databank that provides cost information to the health industry and consumers.

“That really shows the stress on the health system and the impact on the individuals,” said Gelburd.

The Fair Health study found a sharp difference in how much insurers spend on individual patients with such a diagnosis.

On average, insurers spend $3,435 a year on an individual patient, but for those with an opioid dependence or abuse diagnosis, that amount jumps to $19,333. Those numbers reflect what insurers actually paid. The report also includes data on what providers charged, amounts that are lowered by their contracts with insurers.

The study, set to be released Tuesday, builds on one Fair Health released in early August that found a 3,000 percent increase in the volume of insurance claims related to opioid dependence diagnoses between 2007 and 2014.

The latest study – part of a series – offers amounts associated with claims billed by providers and paid by insurers for the types of medical services used.

Both studies use de-identified claims data from insurers representing more than 150 million insured Americans who either have insurance through work or buy coverage on their own.

There have been other efforts by several researchers to quantify the cost of the opioid problem on the overall economy, estimated in the tens of billions of dollars.

The new report adds to the available data “that it’s not just the human cost associated with the opioid crisis that is enormous, but also that the economic costs are staggering,” said Dr. Andrew Kolodny, senior scientist at Brandeis University. He did not work on the study.

The surge in spending on patients with opioid diagnoses is likely a combination of factors, the report notes. As media attention focuses on drug dependency, more people may be seeking treatment. At the same time, prescription and illegal use of narcotics may also be increasing.

The study found that emergency room visits and laboratory tests accounted for much of the spending.

Based on claims volume, the fastest-growing set of services in terms of utilization were for alcohol or drug therapy. Lab tests, including checks for barbiturate or opioid use, were not far behind.

Researchers did not use 2015 data for lab test costs, noting that a change in billing codes was made that increased the number of categories – and, in some cases, appear to generate higher payments by insurers. It is too early to estimate the long-term effects of the change, Gelburd said.

The report gives some examples of the changes, however. For example, one billing code for a test on opiate use commonly brought in a $31 payment from insurers prior to the change. The two billing codes that replaced it now are commonly paid at $78 and $156.

The new billing codes may reflect new technology in testing, said Gelburd. She said some observers speculate that the rapid increase in lab spending might reflect that, with more patients in therapy, the tests are being used to ensure they are taking their proper medications and not abusing narcotics.

But the spending might also reflect a growing use of very expensive urine and blood tests when less expensive ones would be sufficient, said Kolodny.

“I worry about profiteering,” said Kolodny. “We do need tests, but not the expensive ones. A lot of clinics are making extra money off these lab tests.”

The overall increase in spending across all types of medical services “is a societal issue,” said Gelburd, who says policymakers need to ensure that changes are made to address the problem.

“Are medical school curricula adjusting to recognize the growing need for these services? Are insurers increasing the number of providers in their networks to ensure sufficient access? Are consumers being educated? It’s an issue that has to be dealt with in all quadrants.”

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

The nation’s ongoing opioid problem comes with staggering physical and emotional costs to patients and families. But the dollar cost to the health system has been harder to peg. Now a new report shows a more than 1,300 percent rise in spending by health insurers in a four-year period on patients with a diagnosis of opioid dependence or abuse.

From 2011 to 2015, insurers’ payments to hospitals, laboratories, treatment centers and other medical providers for these patients grew from $32 million to $446 million – a 1,375 percent increase.

While that’s a small portion of the overall spending on medical care in the United States, the rapid rise is cause for concern, says Robin Gelburd, president of Fair Health, a nonprofit databank that provides cost information to the health industry and consumers.

“That really shows the stress on the health system and the impact on the individuals,” said Gelburd.

The Fair Health study found a sharp difference in how much insurers spend on individual patients with such a diagnosis.

On average, insurers spend $3,435 a year on an individual patient, but for those with an opioid dependence or abuse diagnosis, that amount jumps to $19,333. Those numbers reflect what insurers actually paid. The report also includes data on what providers charged, amounts that are lowered by their contracts with insurers.

The study, set to be released Tuesday, builds on one Fair Health released in early August that found a 3,000 percent increase in the volume of insurance claims related to opioid dependence diagnoses between 2007 and 2014.

The latest study – part of a series – offers amounts associated with claims billed by providers and paid by insurers for the types of medical services used.

Both studies use de-identified claims data from insurers representing more than 150 million insured Americans who either have insurance through work or buy coverage on their own.

There have been other efforts by several researchers to quantify the cost of the opioid problem on the overall economy, estimated in the tens of billions of dollars.

The new report adds to the available data “that it’s not just the human cost associated with the opioid crisis that is enormous, but also that the economic costs are staggering,” said Dr. Andrew Kolodny, senior scientist at Brandeis University. He did not work on the study.

The surge in spending on patients with opioid diagnoses is likely a combination of factors, the report notes. As media attention focuses on drug dependency, more people may be seeking treatment. At the same time, prescription and illegal use of narcotics may also be increasing.

The study found that emergency room visits and laboratory tests accounted for much of the spending.

Based on claims volume, the fastest-growing set of services in terms of utilization were for alcohol or drug therapy. Lab tests, including checks for barbiturate or opioid use, were not far behind.

Researchers did not use 2015 data for lab test costs, noting that a change in billing codes was made that increased the number of categories – and, in some cases, appear to generate higher payments by insurers. It is too early to estimate the long-term effects of the change, Gelburd said.

The report gives some examples of the changes, however. For example, one billing code for a test on opiate use commonly brought in a $31 payment from insurers prior to the change. The two billing codes that replaced it now are commonly paid at $78 and $156.

The new billing codes may reflect new technology in testing, said Gelburd. She said some observers speculate that the rapid increase in lab spending might reflect that, with more patients in therapy, the tests are being used to ensure they are taking their proper medications and not abusing narcotics.

But the spending might also reflect a growing use of very expensive urine and blood tests when less expensive ones would be sufficient, said Kolodny.

“I worry about profiteering,” said Kolodny. “We do need tests, but not the expensive ones. A lot of clinics are making extra money off these lab tests.”

The overall increase in spending across all types of medical services “is a societal issue,” said Gelburd, who says policymakers need to ensure that changes are made to address the problem.

“Are medical school curricula adjusting to recognize the growing need for these services? Are insurers increasing the number of providers in their networks to ensure sufficient access? Are consumers being educated? It’s an issue that has to be dealt with in all quadrants.”

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

ROME – There’s good news for the millions of patients living with a first-generation metallic drug-eluting stent for coronary revascularization implanted in years past: The devices perform reassuringly well a full decade after implantation, Lorenz Räber, MD, reported at the annual congress of the European Society of Cardiology.

That’s the key message of the SIRTAX VERY LATE study, the only randomized trial of first-generation drug-eluting stents (DES) that didn’t turn out the lights at a maximum of 5 years of follow-up. In fact, at the 10-year mark, SIRTAX VERY LATE shows that regardless of whether the first-generation DES was paclitaxel- or sirolimus-eluting, the risk of major adverse cardiac events due to device failure was substantially lower in the second half-decade than in the first 5 years after deployment, according to Dr. Räber of Bern (Switzerland) University Hospital.

Bruce Jancin/Frontline Medical News

More specifically, the cumulative risk of ischemia-driven target lesion revascularization was 14.6% at 5 years and 17.7% at 10 years, while the 5- and 10-year cumulative risks of definite stent thrombosis were 4.5% and 5.6%, respectively.

The annual risk of ischemia-driven target lesion revascularization dropped by 64%, from 1.8%/year during years 1-5 to 0.7% during years 6-10. Similarly, the annual risk of definite stent thrombosis fell from 0.67%/year to 0.23%/year after year 5, a 69% relative risk reduction. And importantly, these attenuations in risk occurred independent of age.

“The lower risk of late clinical events suggests stabilization of delayed arterial healing over time after first-generation DES implantation, with reduced chronic inflammation and neoatherosclerosis,” he said.

This is reassuring in light of the stormy history of the first-generation DES. Three years after the devices came on the U.S. market, the so-called ESC firestorm erupted. At the 2006 ESC congress, investigators presented meta-analyses suggesting the devices carried a possible late increased thrombotic risk beyond the then-recommended 3-6 months of prescribed dual-antiplatelet therapy. The use of these devices declined sharply in response, even though a Food and Drug Administration advisory panel charged with looking at the totality of evidence concluded that concerns about thrombosis didn’t outweigh the benefits of the first-generation DES over bare-metal stents.

The reductions in very late stent thrombosis and ischemia-driven target lesion revascularization beyond 5 years seen in the SIRTAX VERY LATE trial occurred despite the fact that only 15% of patients were on dual-antiplatelet therapy throughout the first 5 years and 11% were on dual-antiplatelet therapy afterwards, Dr. Räber noted.

“Our findings may have implications for secondary prevention after PCI with a first-generation DES, including the need for long-term antiplatelet therapy,” the cardiologist added.

The previously reported 5-year results of SIRTAX (the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization trial) showed a steady increase over time in late lumen loss and an ongoing risk of very late stent thrombosis (Circulation. 2011 Jun 21;123(24):2819-28). Much the same was seen at the 5-year mark in the other major trials of first-generation DES, including RAVEL, SIRIUS, and TAXUS.

However, all those studies ended at 5 years, leaving unanswered the key question of what happens later. Cardiologists have wondered if the first-generation DES they put in their patients years ago were associated with a continued steady climb in the risk of device-related adverse events, or if the risk plateaued or even dropped off. The SIRTAX VERY LATE study was conducted in order to provide answers.

SIRTAX included 1,012 Swiss patients randomized to coronary revascularization using a first-generation sirolimus- or paclitaxel-eluting stent in 2003-2004. Roughly half had stable coronary artery disease and half presented with acute coronary syndromes. The 10-year follow-up conducted in the SIRTAX VERY LATE study captured 895 (88%) of the original 1,012 subjects.

The cumulative incidence of major cardiac adverse events – a composite of cardiac death, MI, and ischemia-driven target lesion revascularization – was 20.8% at 5 years and 33.8% at 10 years. The rate was similar between years 1-5 and 6-10.

The cumulative all-cause mortality rate was 10.4% at 5 years and 24.2% at 10 years. The rate was 2.0%/year during years 1-5 and accelerated significantly to 3.1%/year in years 6-10. However, this increase appears to be largely due to the background impact of advancing age rather than to any effect of having a first-generation DES. The 5- and 10-year all-cause mortality rates in the age- and sex-matched general Swiss population are similar to those seen in SIRTAX VERY LATE, at 9.6% and 22.1%, respectively, the cardiologist observed.

The cumulative incidence of MI in the study population was 7% at 5 years and 9.7% at 10 years. Between years 1-5 the rate was 0.9%/year, dropping to 0.6%/year during years 6-10.

 

One of the useful potential purposes for the new SIRTAX VERY LATE follow-up data beyond 5 years is that the results could serve as a benchmark in evaluating the long-term safety and efficacy of the much newer drug-eluting fully bioresorbable vascular scaffolds, since the potential benefits of these new devices may not appear until relatively late, after the devices themselves have disappeared. SIRTAX VERY LATE sets the bar for stent-related adverse events 5 years or more after device implantation at an annual risk of less than 0.3%/year for stent thrombosis and less than 1%/year for ischemia-driven target lesion revascularization.

Session co-chair Hector Bueno, MD, drew attention to the fact that no significant differences in clinical outcomes were seen at either 5 or 10 years between the sirolimus- and paclitaxel-eluting stent recipients. That’s noteworthy because more than a decade ago when the primary endpoint of SIRTAX was reported, much was made of the finding that the 9-month rate of major adverse cardiac events was significantly lower in the sirolimus-eluting stent group (N Engl J Med. 2005 Aug 18;353[7]:653-62). Over time, any outcome differences between the two devices were erased, observed Dr. Bueno of Complutense University of Madrid.

The SIRTAX VERY LATE study was funded by grants from Bern University Hospital. Dr. Räber reported having no relevant financial interests.

Simultaneously with his presentation in Rome at ESC 2016, the study results were published online (Eur Heart J. 2016 Aug 30. doi: 10.1093/eurheartj/ehw343).

[email protected]

ROME – There’s good news for the millions of patients living with a first-generation metallic drug-eluting stent for coronary revascularization implanted in years past: The devices perform reassuringly well a full decade after implantation, Lorenz Räber, MD, reported at the annual congress of the European Society of Cardiology.

That’s the key message of the SIRTAX VERY LATE study, the only randomized trial of first-generation drug-eluting stents (DES) that didn’t turn out the lights at a maximum of 5 years of follow-up. In fact, at the 10-year mark, SIRTAX VERY LATE shows that regardless of whether the first-generation DES was paclitaxel- or sirolimus-eluting, the risk of major adverse cardiac events due to device failure was substantially lower in the second half-decade than in the first 5 years after deployment, according to Dr. Räber of Bern (Switzerland) University Hospital.

Bruce Jancin/Frontline Medical News

More specifically, the cumulative risk of ischemia-driven target lesion revascularization was 14.6% at 5 years and 17.7% at 10 years, while the 5- and 10-year cumulative risks of definite stent thrombosis were 4.5% and 5.6%, respectively.

The annual risk of ischemia-driven target lesion revascularization dropped by 64%, from 1.8%/year during years 1-5 to 0.7% during years 6-10. Similarly, the annual risk of definite stent thrombosis fell from 0.67%/year to 0.23%/year after year 5, a 69% relative risk reduction. And importantly, these attenuations in risk occurred independent of age.

“The lower risk of late clinical events suggests stabilization of delayed arterial healing over time after first-generation DES implantation, with reduced chronic inflammation and neoatherosclerosis,” he said.

This is reassuring in light of the stormy history of the first-generation DES. Three years after the devices came on the U.S. market, the so-called ESC firestorm erupted. At the 2006 ESC congress, investigators presented meta-analyses suggesting the devices carried a possible late increased thrombotic risk beyond the then-recommended 3-6 months of prescribed dual-antiplatelet therapy. The use of these devices declined sharply in response, even though a Food and Drug Administration advisory panel charged with looking at the totality of evidence concluded that concerns about thrombosis didn’t outweigh the benefits of the first-generation DES over bare-metal stents.

The reductions in very late stent thrombosis and ischemia-driven target lesion revascularization beyond 5 years seen in the SIRTAX VERY LATE trial occurred despite the fact that only 15% of patients were on dual-antiplatelet therapy throughout the first 5 years and 11% were on dual-antiplatelet therapy afterwards, Dr. Räber noted.

“Our findings may have implications for secondary prevention after PCI with a first-generation DES, including the need for long-term antiplatelet therapy,” the cardiologist added.

The previously reported 5-year results of SIRTAX (the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization trial) showed a steady increase over time in late lumen loss and an ongoing risk of very late stent thrombosis (Circulation. 2011 Jun 21;123(24):2819-28). Much the same was seen at the 5-year mark in the other major trials of first-generation DES, including RAVEL, SIRIUS, and TAXUS.

However, all those studies ended at 5 years, leaving unanswered the key question of what happens later. Cardiologists have wondered if the first-generation DES they put in their patients years ago were associated with a continued steady climb in the risk of device-related adverse events, or if the risk plateaued or even dropped off. The SIRTAX VERY LATE study was conducted in order to provide answers.

SIRTAX included 1,012 Swiss patients randomized to coronary revascularization using a first-generation sirolimus- or paclitaxel-eluting stent in 2003-2004. Roughly half had stable coronary artery disease and half presented with acute coronary syndromes. The 10-year follow-up conducted in the SIRTAX VERY LATE study captured 895 (88%) of the original 1,012 subjects.

The cumulative incidence of major cardiac adverse events – a composite of cardiac death, MI, and ischemia-driven target lesion revascularization – was 20.8% at 5 years and 33.8% at 10 years. The rate was similar between years 1-5 and 6-10.

The cumulative all-cause mortality rate was 10.4% at 5 years and 24.2% at 10 years. The rate was 2.0%/year during years 1-5 and accelerated significantly to 3.1%/year in years 6-10. However, this increase appears to be largely due to the background impact of advancing age rather than to any effect of having a first-generation DES. The 5- and 10-year all-cause mortality rates in the age- and sex-matched general Swiss population are similar to those seen in SIRTAX VERY LATE, at 9.6% and 22.1%, respectively, the cardiologist observed.

The cumulative incidence of MI in the study population was 7% at 5 years and 9.7% at 10 years. Between years 1-5 the rate was 0.9%/year, dropping to 0.6%/year during years 6-10.

 

One of the useful potential purposes for the new SIRTAX VERY LATE follow-up data beyond 5 years is that the results could serve as a benchmark in evaluating the long-term safety and efficacy of the much newer drug-eluting fully bioresorbable vascular scaffolds, since the potential benefits of these new devices may not appear until relatively late, after the devices themselves have disappeared. SIRTAX VERY LATE sets the bar for stent-related adverse events 5 years or more after device implantation at an annual risk of less than 0.3%/year for stent thrombosis and less than 1%/year for ischemia-driven target lesion revascularization.

Session co-chair Hector Bueno, MD, drew attention to the fact that no significant differences in clinical outcomes were seen at either 5 or 10 years between the sirolimus- and paclitaxel-eluting stent recipients. That’s noteworthy because more than a decade ago when the primary endpoint of SIRTAX was reported, much was made of the finding that the 9-month rate of major adverse cardiac events was significantly lower in the sirolimus-eluting stent group (N Engl J Med. 2005 Aug 18;353[7]:653-62). Over time, any outcome differences between the two devices were erased, observed Dr. Bueno of Complutense University of Madrid.

The SIRTAX VERY LATE study was funded by grants from Bern University Hospital. Dr. Räber reported having no relevant financial interests.

Simultaneously with his presentation in Rome at ESC 2016, the study results were published online (Eur Heart J. 2016 Aug 30. doi: 10.1093/eurheartj/ehw343).

[email protected]

ROME – There’s good news for the millions of patients living with a first-generation metallic drug-eluting stent for coronary revascularization implanted in years past: The devices perform reassuringly well a full decade after implantation, Lorenz Räber, MD, reported at the annual congress of the European Society of Cardiology.

That’s the key message of the SIRTAX VERY LATE study, the only randomized trial of first-generation drug-eluting stents (DES) that didn’t turn out the lights at a maximum of 5 years of follow-up. In fact, at the 10-year mark, SIRTAX VERY LATE shows that regardless of whether the first-generation DES was paclitaxel- or sirolimus-eluting, the risk of major adverse cardiac events due to device failure was substantially lower in the second half-decade than in the first 5 years after deployment, according to Dr. Räber of Bern (Switzerland) University Hospital.

Bruce Jancin/Frontline Medical News

More specifically, the cumulative risk of ischemia-driven target lesion revascularization was 14.6% at 5 years and 17.7% at 10 years, while the 5- and 10-year cumulative risks of definite stent thrombosis were 4.5% and 5.6%, respectively.

The annual risk of ischemia-driven target lesion revascularization dropped by 64%, from 1.8%/year during years 1-5 to 0.7% during years 6-10. Similarly, the annual risk of definite stent thrombosis fell from 0.67%/year to 0.23%/year after year 5, a 69% relative risk reduction. And importantly, these attenuations in risk occurred independent of age.

“The lower risk of late clinical events suggests stabilization of delayed arterial healing over time after first-generation DES implantation, with reduced chronic inflammation and neoatherosclerosis,” he said.

This is reassuring in light of the stormy history of the first-generation DES. Three years after the devices came on the U.S. market, the so-called ESC firestorm erupted. At the 2006 ESC congress, investigators presented meta-analyses suggesting the devices carried a possible late increased thrombotic risk beyond the then-recommended 3-6 months of prescribed dual-antiplatelet therapy. The use of these devices declined sharply in response, even though a Food and Drug Administration advisory panel charged with looking at the totality of evidence concluded that concerns about thrombosis didn’t outweigh the benefits of the first-generation DES over bare-metal stents.

The reductions in very late stent thrombosis and ischemia-driven target lesion revascularization beyond 5 years seen in the SIRTAX VERY LATE trial occurred despite the fact that only 15% of patients were on dual-antiplatelet therapy throughout the first 5 years and 11% were on dual-antiplatelet therapy afterwards, Dr. Räber noted.

“Our findings may have implications for secondary prevention after PCI with a first-generation DES, including the need for long-term antiplatelet therapy,” the cardiologist added.

The previously reported 5-year results of SIRTAX (the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization trial) showed a steady increase over time in late lumen loss and an ongoing risk of very late stent thrombosis (Circulation. 2011 Jun 21;123(24):2819-28). Much the same was seen at the 5-year mark in the other major trials of first-generation DES, including RAVEL, SIRIUS, and TAXUS.

However, all those studies ended at 5 years, leaving unanswered the key question of what happens later. Cardiologists have wondered if the first-generation DES they put in their patients years ago were associated with a continued steady climb in the risk of device-related adverse events, or if the risk plateaued or even dropped off. The SIRTAX VERY LATE study was conducted in order to provide answers.

SIRTAX included 1,012 Swiss patients randomized to coronary revascularization using a first-generation sirolimus- or paclitaxel-eluting stent in 2003-2004. Roughly half had stable coronary artery disease and half presented with acute coronary syndromes. The 10-year follow-up conducted in the SIRTAX VERY LATE study captured 895 (88%) of the original 1,012 subjects.

The cumulative incidence of major cardiac adverse events – a composite of cardiac death, MI, and ischemia-driven target lesion revascularization – was 20.8% at 5 years and 33.8% at 10 years. The rate was similar between years 1-5 and 6-10.

The cumulative all-cause mortality rate was 10.4% at 5 years and 24.2% at 10 years. The rate was 2.0%/year during years 1-5 and accelerated significantly to 3.1%/year in years 6-10. However, this increase appears to be largely due to the background impact of advancing age rather than to any effect of having a first-generation DES. The 5- and 10-year all-cause mortality rates in the age- and sex-matched general Swiss population are similar to those seen in SIRTAX VERY LATE, at 9.6% and 22.1%, respectively, the cardiologist observed.

The cumulative incidence of MI in the study population was 7% at 5 years and 9.7% at 10 years. Between years 1-5 the rate was 0.9%/year, dropping to 0.6%/year during years 6-10.

 

One of the useful potential purposes for the new SIRTAX VERY LATE follow-up data beyond 5 years is that the results could serve as a benchmark in evaluating the long-term safety and efficacy of the much newer drug-eluting fully bioresorbable vascular scaffolds, since the potential benefits of these new devices may not appear until relatively late, after the devices themselves have disappeared. SIRTAX VERY LATE sets the bar for stent-related adverse events 5 years or more after device implantation at an annual risk of less than 0.3%/year for stent thrombosis and less than 1%/year for ischemia-driven target lesion revascularization.

Session co-chair Hector Bueno, MD, drew attention to the fact that no significant differences in clinical outcomes were seen at either 5 or 10 years between the sirolimus- and paclitaxel-eluting stent recipients. That’s noteworthy because more than a decade ago when the primary endpoint of SIRTAX was reported, much was made of the finding that the 9-month rate of major adverse cardiac events was significantly lower in the sirolimus-eluting stent group (N Engl J Med. 2005 Aug 18;353[7]:653-62). Over time, any outcome differences between the two devices were erased, observed Dr. Bueno of Complutense University of Madrid.

The SIRTAX VERY LATE study was funded by grants from Bern University Hospital. Dr. Räber reported having no relevant financial interests.

Simultaneously with his presentation in Rome at ESC 2016, the study results were published online (Eur Heart J. 2016 Aug 30. doi: 10.1093/eurheartj/ehw343).

[email protected]

Lowering LDL cholesterol level using statins appears to yield the same cardiovascular benefits in rheumatoid arthritis patients as in the general population, a study showed.

Cardiovascular (CV) disease is a common comorbidity in rheumatoid arthritis (RA) patients, who carry an estimated 50% increased risk of CV events or early mortality, compared with the general population. Yet epidemiologic studies have reported that RA patients generally have lower lipid levels than members of the general population, and studies assessing statin therapy in this patient population have yielded mixed results, said JaeJin An, PhD, of the department of pharmacy practice and administration, Western University of Health Sciences, Pomona, Calif., and her associates.

©Ugreen/thinkstockphotos.com

This may be because RA alters lipid metabolism in a complex manner, due to its associated systemic inflammation, the effects of RA drug therapy, and several genetic factors that characterize RA, they noted.

To assess the benefit of statin therapy for primary prevention in RA, the investigators performed a retrospective cohort study using the electronic medical records of adults enrolled in a single large California health care system. They focused on RA patients taking at least one disease-modifying antirheumatic drug who also had hyperlipidemia. In one cohort, 1,522 RA patients were matched for age and sex with 6,511 control subjects who were also in the health care system, and in a second cohort 1,746 RA patients were matched with 2,554 patients who had osteoarthritis (OA).

These study participants were followed for a median of 3-4 years for the development of MI, angina, stroke, transient ischemic attack, intermittent claudication, heart failure, or CV death. Lipid-lowering medications they were taking included atorvastatin, simvastatin, fluvastatin, lovastatin, rosuvastatin, and pravastatin. The study was supported by Bristol-Myers Squibb, maker of pravastatin.

Similar proportions of patients in the three study groups lowered their LDL-C level to clinically recommended levels based on their baseline CV risk: 79% of the RA group, 79% of the general control group, and 80% of the OA control group.

There were no differences in the link between lowering LDL-C level and improved CV outcomes among the three study groups. A reduction in LDL-C was associated with a 29% reduction in the risk of CV events in the RA group plus the general control group, and it was associated with a 50% reduction in the risk of CV events in the RA group plus the OA control group, the investigators reported (J Rheumatol. 2016 Sep 1. doi: 10.3899/jrheum.160110). In a further analysis of the data that adjusted for multiple CV risk factors, lowering LDL-C levels was associated with a similar degree of reduction in CV events in RA patients in the first cohort (hazard ratio, 0.68) and the second cohort (HR, 0.67).

“Our analyses further verified that having RA itself increased CV risk by 76% [compared with general control patients], even after adjusting for traditional risk factors such as age, sex, smoking, hypertension, and diabetes. These findings are consistent with previous findings, which suggest about a 50% higher risk of CV events and mortality among patients with RA relative to the general population,” Dr. An and her associates wrote.

Their results also are consistent with those of the recently reported TRACE-RA (Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Rheumatoid Arthritis) study, which found that lipid-lowering therapy with atorvastatin was associated with a 34% reduction in the primary composite CV endpoint in RA patients.

Bristol-Myers Squibb supported the study, and several coauthors are employees of the company.

[email protected]

Lowering LDL cholesterol level using statins appears to yield the same cardiovascular benefits in rheumatoid arthritis patients as in the general population, a study showed.

Cardiovascular (CV) disease is a common comorbidity in rheumatoid arthritis (RA) patients, who carry an estimated 50% increased risk of CV events or early mortality, compared with the general population. Yet epidemiologic studies have reported that RA patients generally have lower lipid levels than members of the general population, and studies assessing statin therapy in this patient population have yielded mixed results, said JaeJin An, PhD, of the department of pharmacy practice and administration, Western University of Health Sciences, Pomona, Calif., and her associates.

©Ugreen/thinkstockphotos.com

This may be because RA alters lipid metabolism in a complex manner, due to its associated systemic inflammation, the effects of RA drug therapy, and several genetic factors that characterize RA, they noted.

To assess the benefit of statin therapy for primary prevention in RA, the investigators performed a retrospective cohort study using the electronic medical records of adults enrolled in a single large California health care system. They focused on RA patients taking at least one disease-modifying antirheumatic drug who also had hyperlipidemia. In one cohort, 1,522 RA patients were matched for age and sex with 6,511 control subjects who were also in the health care system, and in a second cohort 1,746 RA patients were matched with 2,554 patients who had osteoarthritis (OA).

These study participants were followed for a median of 3-4 years for the development of MI, angina, stroke, transient ischemic attack, intermittent claudication, heart failure, or CV death. Lipid-lowering medications they were taking included atorvastatin, simvastatin, fluvastatin, lovastatin, rosuvastatin, and pravastatin. The study was supported by Bristol-Myers Squibb, maker of pravastatin.

Similar proportions of patients in the three study groups lowered their LDL-C level to clinically recommended levels based on their baseline CV risk: 79% of the RA group, 79% of the general control group, and 80% of the OA control group.

There were no differences in the link between lowering LDL-C level and improved CV outcomes among the three study groups. A reduction in LDL-C was associated with a 29% reduction in the risk of CV events in the RA group plus the general control group, and it was associated with a 50% reduction in the risk of CV events in the RA group plus the OA control group, the investigators reported (J Rheumatol. 2016 Sep 1. doi: 10.3899/jrheum.160110). In a further analysis of the data that adjusted for multiple CV risk factors, lowering LDL-C levels was associated with a similar degree of reduction in CV events in RA patients in the first cohort (hazard ratio, 0.68) and the second cohort (HR, 0.67).

“Our analyses further verified that having RA itself increased CV risk by 76% [compared with general control patients], even after adjusting for traditional risk factors such as age, sex, smoking, hypertension, and diabetes. These findings are consistent with previous findings, which suggest about a 50% higher risk of CV events and mortality among patients with RA relative to the general population,” Dr. An and her associates wrote.

Their results also are consistent with those of the recently reported TRACE-RA (Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Rheumatoid Arthritis) study, which found that lipid-lowering therapy with atorvastatin was associated with a 34% reduction in the primary composite CV endpoint in RA patients.

Bristol-Myers Squibb supported the study, and several coauthors are employees of the company.

[email protected]

Lowering LDL cholesterol level using statins appears to yield the same cardiovascular benefits in rheumatoid arthritis patients as in the general population, a study showed.

Cardiovascular (CV) disease is a common comorbidity in rheumatoid arthritis (RA) patients, who carry an estimated 50% increased risk of CV events or early mortality, compared with the general population. Yet epidemiologic studies have reported that RA patients generally have lower lipid levels than members of the general population, and studies assessing statin therapy in this patient population have yielded mixed results, said JaeJin An, PhD, of the department of pharmacy practice and administration, Western University of Health Sciences, Pomona, Calif., and her associates.

©Ugreen/thinkstockphotos.com

This may be because RA alters lipid metabolism in a complex manner, due to its associated systemic inflammation, the effects of RA drug therapy, and several genetic factors that characterize RA, they noted.

To assess the benefit of statin therapy for primary prevention in RA, the investigators performed a retrospective cohort study using the electronic medical records of adults enrolled in a single large California health care system. They focused on RA patients taking at least one disease-modifying antirheumatic drug who also had hyperlipidemia. In one cohort, 1,522 RA patients were matched for age and sex with 6,511 control subjects who were also in the health care system, and in a second cohort 1,746 RA patients were matched with 2,554 patients who had osteoarthritis (OA).

These study participants were followed for a median of 3-4 years for the development of MI, angina, stroke, transient ischemic attack, intermittent claudication, heart failure, or CV death. Lipid-lowering medications they were taking included atorvastatin, simvastatin, fluvastatin, lovastatin, rosuvastatin, and pravastatin. The study was supported by Bristol-Myers Squibb, maker of pravastatin.

Similar proportions of patients in the three study groups lowered their LDL-C level to clinically recommended levels based on their baseline CV risk: 79% of the RA group, 79% of the general control group, and 80% of the OA control group.

There were no differences in the link between lowering LDL-C level and improved CV outcomes among the three study groups. A reduction in LDL-C was associated with a 29% reduction in the risk of CV events in the RA group plus the general control group, and it was associated with a 50% reduction in the risk of CV events in the RA group plus the OA control group, the investigators reported (J Rheumatol. 2016 Sep 1. doi: 10.3899/jrheum.160110). In a further analysis of the data that adjusted for multiple CV risk factors, lowering LDL-C levels was associated with a similar degree of reduction in CV events in RA patients in the first cohort (hazard ratio, 0.68) and the second cohort (HR, 0.67).

“Our analyses further verified that having RA itself increased CV risk by 76% [compared with general control patients], even after adjusting for traditional risk factors such as age, sex, smoking, hypertension, and diabetes. These findings are consistent with previous findings, which suggest about a 50% higher risk of CV events and mortality among patients with RA relative to the general population,” Dr. An and her associates wrote.

Their results also are consistent with those of the recently reported TRACE-RA (Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Rheumatoid Arthritis) study, which found that lipid-lowering therapy with atorvastatin was associated with a 34% reduction in the primary composite CV endpoint in RA patients.

Bristol-Myers Squibb supported the study, and several coauthors are employees of the company.

[email protected]

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

Federal health officials, pediatricians, and ob.gyns. are imploring Congress to pass an appropriations bill with sufficient money to fight the growing threat of the Zika virus.

“Funding for Zika research, for prevention, and for control efforts – including mosquito surveillance and control – is essentially all spent,” Beth P. Bell, MD, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said during a press conference. The Obama administration “has already transferred millions of dollars from other important programs to help with the Zika response, [but] without additional resources from Congress, critical public health work may not be accomplished.”

©franckreporter/Thinkstock

President Obama asked Congress in February to appropriate $1.9 billion to address all aspects of the Zika virus situation in the United States; partisan politics surrounding funding for Planned Parenthood have derailed passage of the legislation to date.

Without additional, specific funding, development of a Zika vaccine would be severely limited, and virtually no funds would be available to conduct multitiered studies that are critical for protecting both women and children from the virus’ devastating effects, Dr. Bell said. Additionally, money allocated to state health departments for the management of patients with Zika virus would no longer be available. Development of tests for early diagnosis would be slowed or halted altogether.

“Allowing this to happen needlessly puts the American people at risk, and will result in more Zika infections and potentially more babies being born with microcephaly and other birth defects,” Dr. Bell added. “Congress has come back from their recess, and we hope that they will do the right thing.”

The American Congress of Obstetricians and Gynecologists “continues to develop, update, and issue guidance on the risks, prevention, assessment, and treatment of the Zika virus,” primarily through its practice advisories and resources available jointly through the CDC, ACOG president Thomas Gellhaus, MD, said.

“The biggest impact Zika has is on babies, and they are our future,” said Karen Remley, MD, executive director and CEO of the American Academy of Pediatricians, adding that funding is crucial to continue monitoring children who have been born with birth defects, as the long-term development of these and other issues is new territory for doctors across the United States and its territories.

As Congress prepared to adjourn in advance of the primary elections, Senate Majority Leader Mitch McConnell noted that some progress is being made on Zika funding.

“We’ve made a lot of important progress already,” Sen. McConnell said Sept. 12 on the Senate floor. “I expect to move forward this week on a continuing resolution through Dec. 9 at last year’s enacted levels and include funds for Zika control and our veterans. Talks are continuing, and leaders from both parties will meet later this afternoon at the White House to discuss the progress and path forward.”

[email protected]

Federal health officials, pediatricians, and ob.gyns. are imploring Congress to pass an appropriations bill with sufficient money to fight the growing threat of the Zika virus.

“Funding for Zika research, for prevention, and for control efforts – including mosquito surveillance and control – is essentially all spent,” Beth P. Bell, MD, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said during a press conference. The Obama administration “has already transferred millions of dollars from other important programs to help with the Zika response, [but] without additional resources from Congress, critical public health work may not be accomplished.”

©franckreporter/Thinkstock

President Obama asked Congress in February to appropriate $1.9 billion to address all aspects of the Zika virus situation in the United States; partisan politics surrounding funding for Planned Parenthood have derailed passage of the legislation to date.

Without additional, specific funding, development of a Zika vaccine would be severely limited, and virtually no funds would be available to conduct multitiered studies that are critical for protecting both women and children from the virus’ devastating effects, Dr. Bell said. Additionally, money allocated to state health departments for the management of patients with Zika virus would no longer be available. Development of tests for early diagnosis would be slowed or halted altogether.

“Allowing this to happen needlessly puts the American people at risk, and will result in more Zika infections and potentially more babies being born with microcephaly and other birth defects,” Dr. Bell added. “Congress has come back from their recess, and we hope that they will do the right thing.”

The American Congress of Obstetricians and Gynecologists “continues to develop, update, and issue guidance on the risks, prevention, assessment, and treatment of the Zika virus,” primarily through its practice advisories and resources available jointly through the CDC, ACOG president Thomas Gellhaus, MD, said.

“The biggest impact Zika has is on babies, and they are our future,” said Karen Remley, MD, executive director and CEO of the American Academy of Pediatricians, adding that funding is crucial to continue monitoring children who have been born with birth defects, as the long-term development of these and other issues is new territory for doctors across the United States and its territories.

As Congress prepared to adjourn in advance of the primary elections, Senate Majority Leader Mitch McConnell noted that some progress is being made on Zika funding.

“We’ve made a lot of important progress already,” Sen. McConnell said Sept. 12 on the Senate floor. “I expect to move forward this week on a continuing resolution through Dec. 9 at last year’s enacted levels and include funds for Zika control and our veterans. Talks are continuing, and leaders from both parties will meet later this afternoon at the White House to discuss the progress and path forward.”

[email protected]

Federal health officials, pediatricians, and ob.gyns. are imploring Congress to pass an appropriations bill with sufficient money to fight the growing threat of the Zika virus.

“Funding for Zika research, for prevention, and for control efforts – including mosquito surveillance and control – is essentially all spent,” Beth P. Bell, MD, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said during a press conference. The Obama administration “has already transferred millions of dollars from other important programs to help with the Zika response, [but] without additional resources from Congress, critical public health work may not be accomplished.”

©franckreporter/Thinkstock

President Obama asked Congress in February to appropriate $1.9 billion to address all aspects of the Zika virus situation in the United States; partisan politics surrounding funding for Planned Parenthood have derailed passage of the legislation to date.

Without additional, specific funding, development of a Zika vaccine would be severely limited, and virtually no funds would be available to conduct multitiered studies that are critical for protecting both women and children from the virus’ devastating effects, Dr. Bell said. Additionally, money allocated to state health departments for the management of patients with Zika virus would no longer be available. Development of tests for early diagnosis would be slowed or halted altogether.

“Allowing this to happen needlessly puts the American people at risk, and will result in more Zika infections and potentially more babies being born with microcephaly and other birth defects,” Dr. Bell added. “Congress has come back from their recess, and we hope that they will do the right thing.”

The American Congress of Obstetricians and Gynecologists “continues to develop, update, and issue guidance on the risks, prevention, assessment, and treatment of the Zika virus,” primarily through its practice advisories and resources available jointly through the CDC, ACOG president Thomas Gellhaus, MD, said.

“The biggest impact Zika has is on babies, and they are our future,” said Karen Remley, MD, executive director and CEO of the American Academy of Pediatricians, adding that funding is crucial to continue monitoring children who have been born with birth defects, as the long-term development of these and other issues is new territory for doctors across the United States and its territories.

As Congress prepared to adjourn in advance of the primary elections, Senate Majority Leader Mitch McConnell noted that some progress is being made on Zika funding.

“We’ve made a lot of important progress already,” Sen. McConnell said Sept. 12 on the Senate floor. “I expect to move forward this week on a continuing resolution through Dec. 9 at last year’s enacted levels and include funds for Zika control and our veterans. Talks are continuing, and leaders from both parties will meet later this afternoon at the White House to discuss the progress and path forward.”

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Four of the 10 highest-spending lobbyers for the first half of 2016 were in the health sector, with Blue Cross/Blue Shield occupying the sector’s top spot by a relatively small margin, according to the Center for Responsive Politics.

The four health-sectors concerns filled spots 3-6 in the overall top 10. Blue Cross/Blue Shield spent almost $12.1 million on lobbying in the first half of the year, putting it just ahead of the Pharmaceutical Research and Manufacturers of America (PhRMA), which spent $11.8 million. The American Medical Association was next at $11.3 million, followed by the American Hospital Association at $10.9 million, the center reported on OpenSecrets.org.

After those four, the next-highest health-sector spender was Pfizer, which put up almost $6.2 million in lobbying – good for 18th place for the first half of 2016. The health sector itself was the highest spending of the 121 ranked, taking a $266 million bite out of the total $1.6 billion lobbying pie for the year so far, according to the center’s analysis of data downloaded from the Senate Office of Public Records on Aug. 9.

The perennial leading spender on lobbying, the U.S. Chamber of Commerce, was well ahead of second place, with its $52.3 million more than doubling the $21.4 million spent by the National Association of Realtors. The two groups have finished 1-2 in lobbying spending every year since 2012, and the Chamber of Commerce has been the leading spender since 2001, data on OpenSecrets show.

[email protected]

Four of the 10 highest-spending lobbyers for the first half of 2016 were in the health sector, with Blue Cross/Blue Shield occupying the sector’s top spot by a relatively small margin, according to the Center for Responsive Politics.

The four health-sectors concerns filled spots 3-6 in the overall top 10. Blue Cross/Blue Shield spent almost $12.1 million on lobbying in the first half of the year, putting it just ahead of the Pharmaceutical Research and Manufacturers of America (PhRMA), which spent $11.8 million. The American Medical Association was next at $11.3 million, followed by the American Hospital Association at $10.9 million, the center reported on OpenSecrets.org.

After those four, the next-highest health-sector spender was Pfizer, which put up almost $6.2 million in lobbying – good for 18th place for the first half of 2016. The health sector itself was the highest spending of the 121 ranked, taking a $266 million bite out of the total $1.6 billion lobbying pie for the year so far, according to the center’s analysis of data downloaded from the Senate Office of Public Records on Aug. 9.

The perennial leading spender on lobbying, the U.S. Chamber of Commerce, was well ahead of second place, with its $52.3 million more than doubling the $21.4 million spent by the National Association of Realtors. The two groups have finished 1-2 in lobbying spending every year since 2012, and the Chamber of Commerce has been the leading spender since 2001, data on OpenSecrets show.

[email protected]

Four of the 10 highest-spending lobbyers for the first half of 2016 were in the health sector, with Blue Cross/Blue Shield occupying the sector’s top spot by a relatively small margin, according to the Center for Responsive Politics.

The four health-sectors concerns filled spots 3-6 in the overall top 10. Blue Cross/Blue Shield spent almost $12.1 million on lobbying in the first half of the year, putting it just ahead of the Pharmaceutical Research and Manufacturers of America (PhRMA), which spent $11.8 million. The American Medical Association was next at $11.3 million, followed by the American Hospital Association at $10.9 million, the center reported on OpenSecrets.org.

After those four, the next-highest health-sector spender was Pfizer, which put up almost $6.2 million in lobbying – good for 18th place for the first half of 2016. The health sector itself was the highest spending of the 121 ranked, taking a $266 million bite out of the total $1.6 billion lobbying pie for the year so far, according to the center’s analysis of data downloaded from the Senate Office of Public Records on Aug. 9.

The perennial leading spender on lobbying, the U.S. Chamber of Commerce, was well ahead of second place, with its $52.3 million more than doubling the $21.4 million spent by the National Association of Realtors. The two groups have finished 1-2 in lobbying spending every year since 2012, and the Chamber of Commerce has been the leading spender since 2001, data on OpenSecrets show.

[email protected]

There is a paucity of literature on how mechanism of injury may be associated with patient retention. Failure to attend outpatient clinics is a form of noncompliance and a major obstacle to safe, effective, and efficient healthcare delivery. Noncompliance may lead to increased patient morbidity and carries substantial financial implications for the healthcare system.^1,2 In addition to these direct patient and healthcare issues, loss of patient follow-up or the belief of potential loss of follow-up of penetrating trauma patients may also significantly affect research studies. These patients often may be excluded from studies, even if they might otherwise meet inclusion criteria, because of concerns that they are unlikely to follow-up after leaving hospital. Is this myth or fact? To validate or to disprove this selection bias, we conducted a study in which we retrospectively evaluated long bone fractures caused by either penetrating or blunt trauma.

Methods

After obtaining Institutional Review Board approval for this study, we used the trauma database of an American College of Surgeons–verified level I trauma center in a major Midwest metropolitan area to compile a list of all cases of long bone fractures caused by penetrating trauma between 2006 and 2009 (N = 132). Gunshot wounds were the mechanism of injury for the penetrating trauma. We also compiled a list of control cases—long bone fractures caused by blunt trauma in patients demographically matched to the penetrating group patients on sex, race, and age (N = 104) (Table).

The mechanisms of blunt trauma included motor vehicle collisions, pedestrians struck by vehicles, falls, altercations, and crush injuries.

We retrospectively performed chart reviews to obtain patient follow-up data 3, 6, 9, and 12 months after injury from penetrating or blunt trauma. Patients scheduled to return on an as-needed basis were considered to have completed follow-up. The 2 groups were also statistically compared with respect to sex, race, age, surgical fixation, and history of tobacco, alcohol, or drug use.

SAS/STAT Version 8 (SAS Institute) was used to test the equality of survival functions (patient retention) for the penetrating and blunt trauma patient groups. A similar comparison was made for the categories of sex, race, and age. Pearson χ² test was used to compare the 12-month survival rates of the 2 treatment groups across sex and race. Binary logistic regression was used to compare the 12-month survival rates of the 2 treatment groups removing the effect of age. A comparison of the frequency distributions of the 2 treatment groups with respect to alcohol use, tobacco use, drug use, and surgical intervention was also performed. Power analysis showed power of more than 90% in detecting at least a 20% difference in the follow-up rates between the penetrating and blunt trauma groups based on our sample size.

Results

There was no statistically significant difference (P = .736) between the penetrating and blunt trauma patients in terms of follow-up within 1 year after injury. At 1 year, 103 (78%) of the 132 penetrating trauma patients and 83 (80%) of the 104 blunt trauma patients were lost to follow-up (Figure).

There was no statistically significant difference in the follow-up rates for sex (P = .12), race (P = .96), or age (P = .37). There was no statistically significant difference between the penetrating and blunt trauma groups with respect to sex (P = .54), race (P = .28), age (P = .18), tobacco use (P = .13), or alcohol use (P = .06). Of the 132 patients in the penetrating trauma group, 50 were African American men in their 20s. This demographic makes up 38% of all patients in the penetrating trauma group. The database of blunt trauma long bone fractures was used to demographically match the penetrating trauma group. The blunt trauma database had 1003 patients, from which 104 were matched to the penetrating trauma group. When matches were sought for the African American men in their 20s, only 21 were found in the blunt trauma database, and they were used (Table). There was a statistically significant difference between the 2 groups with respect to drug use (P = .02), with a higher prevalence in the penetrating trauma group (30.3% vs 17.31%). There was also a statistically significant difference between the 2 groups with respect to surgical fixation (P = .003), with a higher rate of surgery in the blunt trauma group (89% vs 75%). The blunt trauma group was demographically matched to the penetrating trauma group with the underlying criterion being long bone fracture. The specific long bone injury was not matched between the 2 groups. Evaluation of the data showed a higher percentage of upper extremity fractures in the penetrating trauma group (38%) than in the blunt trauma group (29%). On further inspection, we found that 21% of the penetrating trauma group had humerus fractures, for which only 48% underwent surgery. In comparison, only 5.8% of the blunt trauma group had humerus fractures, for which 83% underwent surgery. This variation in long bone distribution between the 2 groups explains our finding a higher propensity for surgical fixation in the blunt trauma group (89%) compared with the penetrating trauma group (75%).

 

Discussion

Trauma outcomes historically have been difficult to determine because of lack of patient follow-up. In a simulation series, Zelle and colleagues³ found that the turning point from significant to nonsignificant varied from 15% to 75% loss of follow-up, thus compromising the validity of a study. They and others have emphasized the importance of establishing research protocols to minimize follow-up loss and eliminate reporting bias, ensure randomization, and report accurate outcomes.^3-7

Very few have tried to investigate factors associated with failure to follow up after trauma.^1,2,4 Leukhardt and colleagues⁴ evaluated the medical services that trauma patients follow up with most often. Orthopedic surgery had the largest portion of follow-up visits (37%), followed by the trauma surgery clinic and the emergency department (19% each). The authors also found that penetrating trauma patients were more likely to follow up, though more than 90% of the authors’ patients had blunt trauma. Although our study did not support their finding, it does call into question the commonly held belief that penetrating trauma patients are less likely to follow up, as our study found no difference in follow-up between penetrating and blunt trauma patients.

One of the most interesting findings in this retrospective study is that almost 80% of patients were lost to follow-up regardless of mechanism of injury. Most prospective studies try to reduce loss to follow-up to below 10%. This difference may be attributable to having a dedicated research team and the resources required to ensure follow-up of research patients to improve follow-up beyond baseline values. At our institution, 13 prospective studies (most multicenter) are currently enrolling patients, and the worst loss to follow-up has been 30%. The majority of the studies have loss to follow-up of 15% or less. This low rate represents a significant difference from the 80% “baseline” clinical loss to follow-up for the blunt and penetrating trauma patients treated at our institution, based on the findings of this study. We have been improving follow-up by having dedicated research coordinators call patients to remind them of their appointments (all clinic patients who are not research patients receive a recorded reminder); by having the hospital agree that research patients can be seen without charge (by the facility or the physician), which helps defray costs to the patient; and by excluding patients the principal investigator thinks are unlikely to follow up. Patients unlikely to follow up are routinely excluded by all centers that enroll in prospective studies. Although it is difficult to quantitate, this factor may play a large role in reducing loss to follow-up. Penetrating trauma patients historically routinely biased investigators to exclude them from studies, regardless of whether being considered unlikely to follow-up was an exclusion criterion. Our study results suggest this bias may not be valid.

Our study evaluated the role of mechanism of injury, penetrating or blunt trauma, and the respective orthopedic follow-up. There was no statistically significant difference in the 1-year follow-up rate based on the mechanism of injury. Our study was conducted with a well-matched control group that eliminated potential confounding variables, such as sex, race, age, tobacco use, and alcohol use. Although the prevalence of drug use was higher in the penetrating trauma group, patient retention seemed not to be affected by it. Surprisingly, patient loss to follow-up was extremely high (almost 80%) for both the penetrating and blunt trauma patient groups at the 1-year mark. Our findings call into question the commonly accepted theory that patients with penetrating injuries are less likely to follow up, at least in an academic level I trauma center population. We suggest that the commonly held belief that penetrating trauma patients are less likely to follow up may not be valid and that, when prospective studies are designed, it may not be appropriate to exclude penetrating trauma patients on this basis alone.

The primary limitation of this study is that it was performed at a single institution. Eighty-five percent of blunt trauma patients and 93% of penetrating trauma patients live in the county that is predominantly served by our institution, and electronic medical records from all major hospitals in the metropolitan area are linked, suggesting that the large majority of patients lost to follow-up do not seek further medical care, at least not from local facilities in our metropolitan area. A prospective multicenter study is being designed to help us gain a better understanding of the variables that affect musculoskeletal trauma patient follow-up and learn interventional strategies that can be used to improve patient retention.

Dr. Turner is an Orthopedic Surgeon, Rockwood Clinic, Spokane, Washington. Dr. Turner was a resident at the time the article was written. Dr. Hiatt is an Anesthesia Resident, University of Louisville Department of Anesthesiology and Perioperative Medicine, Louisville, Kentucky. Dr. Mullis is Chief of the Orthopaedic Trauma Service, Eskenazi Health, and Professor & Program Director, Indiana University School of Medicine Department of Orthopaedics, Indianapolis, Indiana.

Acknowledgments: This study was first reported in a poster presentation at the annual meeting of the Orthopaedic Trauma Association, October 2013, Phoenix, Arizona.

The authors gratefully acknowledge and thank Jyoti Sarkar, PhD, for his assistance with statistical analysis and manuscript preparation.

Am J Orthop. 2016;45(6):E331-E334. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

There is a paucity of literature on how mechanism of injury may be associated with patient retention. Failure to attend outpatient clinics is a form of noncompliance and a major obstacle to safe, effective, and efficient healthcare delivery. Noncompliance may lead to increased patient morbidity and carries substantial financial implications for the healthcare system.^1,2 In addition to these direct patient and healthcare issues, loss of patient follow-up or the belief of potential loss of follow-up of penetrating trauma patients may also significantly affect research studies. These patients often may be excluded from studies, even if they might otherwise meet inclusion criteria, because of concerns that they are unlikely to follow-up after leaving hospital. Is this myth or fact? To validate or to disprove this selection bias, we conducted a study in which we retrospectively evaluated long bone fractures caused by either penetrating or blunt trauma.

Methods

After obtaining Institutional Review Board approval for this study, we used the trauma database of an American College of Surgeons–verified level I trauma center in a major Midwest metropolitan area to compile a list of all cases of long bone fractures caused by penetrating trauma between 2006 and 2009 (N = 132). Gunshot wounds were the mechanism of injury for the penetrating trauma. We also compiled a list of control cases—long bone fractures caused by blunt trauma in patients demographically matched to the penetrating group patients on sex, race, and age (N = 104) (Table).

The mechanisms of blunt trauma included motor vehicle collisions, pedestrians struck by vehicles, falls, altercations, and crush injuries.

We retrospectively performed chart reviews to obtain patient follow-up data 3, 6, 9, and 12 months after injury from penetrating or blunt trauma. Patients scheduled to return on an as-needed basis were considered to have completed follow-up. The 2 groups were also statistically compared with respect to sex, race, age, surgical fixation, and history of tobacco, alcohol, or drug use.

SAS/STAT Version 8 (SAS Institute) was used to test the equality of survival functions (patient retention) for the penetrating and blunt trauma patient groups. A similar comparison was made for the categories of sex, race, and age. Pearson χ² test was used to compare the 12-month survival rates of the 2 treatment groups across sex and race. Binary logistic regression was used to compare the 12-month survival rates of the 2 treatment groups removing the effect of age. A comparison of the frequency distributions of the 2 treatment groups with respect to alcohol use, tobacco use, drug use, and surgical intervention was also performed. Power analysis showed power of more than 90% in detecting at least a 20% difference in the follow-up rates between the penetrating and blunt trauma groups based on our sample size.

Results

There was no statistically significant difference (P = .736) between the penetrating and blunt trauma patients in terms of follow-up within 1 year after injury. At 1 year, 103 (78%) of the 132 penetrating trauma patients and 83 (80%) of the 104 blunt trauma patients were lost to follow-up (Figure).

There was no statistically significant difference in the follow-up rates for sex (P = .12), race (P = .96), or age (P = .37). There was no statistically significant difference between the penetrating and blunt trauma groups with respect to sex (P = .54), race (P = .28), age (P = .18), tobacco use (P = .13), or alcohol use (P = .06). Of the 132 patients in the penetrating trauma group, 50 were African American men in their 20s. This demographic makes up 38% of all patients in the penetrating trauma group. The database of blunt trauma long bone fractures was used to demographically match the penetrating trauma group. The blunt trauma database had 1003 patients, from which 104 were matched to the penetrating trauma group. When matches were sought for the African American men in their 20s, only 21 were found in the blunt trauma database, and they were used (Table). There was a statistically significant difference between the 2 groups with respect to drug use (P = .02), with a higher prevalence in the penetrating trauma group (30.3% vs 17.31%). There was also a statistically significant difference between the 2 groups with respect to surgical fixation (P = .003), with a higher rate of surgery in the blunt trauma group (89% vs 75%). The blunt trauma group was demographically matched to the penetrating trauma group with the underlying criterion being long bone fracture. The specific long bone injury was not matched between the 2 groups. Evaluation of the data showed a higher percentage of upper extremity fractures in the penetrating trauma group (38%) than in the blunt trauma group (29%). On further inspection, we found that 21% of the penetrating trauma group had humerus fractures, for which only 48% underwent surgery. In comparison, only 5.8% of the blunt trauma group had humerus fractures, for which 83% underwent surgery. This variation in long bone distribution between the 2 groups explains our finding a higher propensity for surgical fixation in the blunt trauma group (89%) compared with the penetrating trauma group (75%).

 

Discussion

Trauma outcomes historically have been difficult to determine because of lack of patient follow-up. In a simulation series, Zelle and colleagues³ found that the turning point from significant to nonsignificant varied from 15% to 75% loss of follow-up, thus compromising the validity of a study. They and others have emphasized the importance of establishing research protocols to minimize follow-up loss and eliminate reporting bias, ensure randomization, and report accurate outcomes.^3-7

Very few have tried to investigate factors associated with failure to follow up after trauma.^1,2,4 Leukhardt and colleagues⁴ evaluated the medical services that trauma patients follow up with most often. Orthopedic surgery had the largest portion of follow-up visits (37%), followed by the trauma surgery clinic and the emergency department (19% each). The authors also found that penetrating trauma patients were more likely to follow up, though more than 90% of the authors’ patients had blunt trauma. Although our study did not support their finding, it does call into question the commonly held belief that penetrating trauma patients are less likely to follow up, as our study found no difference in follow-up between penetrating and blunt trauma patients.

One of the most interesting findings in this retrospective study is that almost 80% of patients were lost to follow-up regardless of mechanism of injury. Most prospective studies try to reduce loss to follow-up to below 10%. This difference may be attributable to having a dedicated research team and the resources required to ensure follow-up of research patients to improve follow-up beyond baseline values. At our institution, 13 prospective studies (most multicenter) are currently enrolling patients, and the worst loss to follow-up has been 30%. The majority of the studies have loss to follow-up of 15% or less. This low rate represents a significant difference from the 80% “baseline” clinical loss to follow-up for the blunt and penetrating trauma patients treated at our institution, based on the findings of this study. We have been improving follow-up by having dedicated research coordinators call patients to remind them of their appointments (all clinic patients who are not research patients receive a recorded reminder); by having the hospital agree that research patients can be seen without charge (by the facility or the physician), which helps defray costs to the patient; and by excluding patients the principal investigator thinks are unlikely to follow up. Patients unlikely to follow up are routinely excluded by all centers that enroll in prospective studies. Although it is difficult to quantitate, this factor may play a large role in reducing loss to follow-up. Penetrating trauma patients historically routinely biased investigators to exclude them from studies, regardless of whether being considered unlikely to follow-up was an exclusion criterion. Our study results suggest this bias may not be valid.

Our study evaluated the role of mechanism of injury, penetrating or blunt trauma, and the respective orthopedic follow-up. There was no statistically significant difference in the 1-year follow-up rate based on the mechanism of injury. Our study was conducted with a well-matched control group that eliminated potential confounding variables, such as sex, race, age, tobacco use, and alcohol use. Although the prevalence of drug use was higher in the penetrating trauma group, patient retention seemed not to be affected by it. Surprisingly, patient loss to follow-up was extremely high (almost 80%) for both the penetrating and blunt trauma patient groups at the 1-year mark. Our findings call into question the commonly accepted theory that patients with penetrating injuries are less likely to follow up, at least in an academic level I trauma center population. We suggest that the commonly held belief that penetrating trauma patients are less likely to follow up may not be valid and that, when prospective studies are designed, it may not be appropriate to exclude penetrating trauma patients on this basis alone.

The primary limitation of this study is that it was performed at a single institution. Eighty-five percent of blunt trauma patients and 93% of penetrating trauma patients live in the county that is predominantly served by our institution, and electronic medical records from all major hospitals in the metropolitan area are linked, suggesting that the large majority of patients lost to follow-up do not seek further medical care, at least not from local facilities in our metropolitan area. A prospective multicenter study is being designed to help us gain a better understanding of the variables that affect musculoskeletal trauma patient follow-up and learn interventional strategies that can be used to improve patient retention.

Dr. Turner is an Orthopedic Surgeon, Rockwood Clinic, Spokane, Washington. Dr. Turner was a resident at the time the article was written. Dr. Hiatt is an Anesthesia Resident, University of Louisville Department of Anesthesiology and Perioperative Medicine, Louisville, Kentucky. Dr. Mullis is Chief of the Orthopaedic Trauma Service, Eskenazi Health, and Professor & Program Director, Indiana University School of Medicine Department of Orthopaedics, Indianapolis, Indiana.

Acknowledgments: This study was first reported in a poster presentation at the annual meeting of the Orthopaedic Trauma Association, October 2013, Phoenix, Arizona.

The authors gratefully acknowledge and thank Jyoti Sarkar, PhD, for his assistance with statistical analysis and manuscript preparation.

Am J Orthop. 2016;45(6):E331-E334. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

There is a paucity of literature on how mechanism of injury may be associated with patient retention. Failure to attend outpatient clinics is a form of noncompliance and a major obstacle to safe, effective, and efficient healthcare delivery. Noncompliance may lead to increased patient morbidity and carries substantial financial implications for the healthcare system.^1,2 In addition to these direct patient and healthcare issues, loss of patient follow-up or the belief of potential loss of follow-up of penetrating trauma patients may also significantly affect research studies. These patients often may be excluded from studies, even if they might otherwise meet inclusion criteria, because of concerns that they are unlikely to follow-up after leaving hospital. Is this myth or fact? To validate or to disprove this selection bias, we conducted a study in which we retrospectively evaluated long bone fractures caused by either penetrating or blunt trauma.

Methods

After obtaining Institutional Review Board approval for this study, we used the trauma database of an American College of Surgeons–verified level I trauma center in a major Midwest metropolitan area to compile a list of all cases of long bone fractures caused by penetrating trauma between 2006 and 2009 (N = 132). Gunshot wounds were the mechanism of injury for the penetrating trauma. We also compiled a list of control cases—long bone fractures caused by blunt trauma in patients demographically matched to the penetrating group patients on sex, race, and age (N = 104) (Table).

The mechanisms of blunt trauma included motor vehicle collisions, pedestrians struck by vehicles, falls, altercations, and crush injuries.

We retrospectively performed chart reviews to obtain patient follow-up data 3, 6, 9, and 12 months after injury from penetrating or blunt trauma. Patients scheduled to return on an as-needed basis were considered to have completed follow-up. The 2 groups were also statistically compared with respect to sex, race, age, surgical fixation, and history of tobacco, alcohol, or drug use.

SAS/STAT Version 8 (SAS Institute) was used to test the equality of survival functions (patient retention) for the penetrating and blunt trauma patient groups. A similar comparison was made for the categories of sex, race, and age. Pearson χ² test was used to compare the 12-month survival rates of the 2 treatment groups across sex and race. Binary logistic regression was used to compare the 12-month survival rates of the 2 treatment groups removing the effect of age. A comparison of the frequency distributions of the 2 treatment groups with respect to alcohol use, tobacco use, drug use, and surgical intervention was also performed. Power analysis showed power of more than 90% in detecting at least a 20% difference in the follow-up rates between the penetrating and blunt trauma groups based on our sample size.

Results

There was no statistically significant difference (P = .736) between the penetrating and blunt trauma patients in terms of follow-up within 1 year after injury. At 1 year, 103 (78%) of the 132 penetrating trauma patients and 83 (80%) of the 104 blunt trauma patients were lost to follow-up (Figure).

There was no statistically significant difference in the follow-up rates for sex (P = .12), race (P = .96), or age (P = .37). There was no statistically significant difference between the penetrating and blunt trauma groups with respect to sex (P = .54), race (P = .28), age (P = .18), tobacco use (P = .13), or alcohol use (P = .06). Of the 132 patients in the penetrating trauma group, 50 were African American men in their 20s. This demographic makes up 38% of all patients in the penetrating trauma group. The database of blunt trauma long bone fractures was used to demographically match the penetrating trauma group. The blunt trauma database had 1003 patients, from which 104 were matched to the penetrating trauma group. When matches were sought for the African American men in their 20s, only 21 were found in the blunt trauma database, and they were used (Table). There was a statistically significant difference between the 2 groups with respect to drug use (P = .02), with a higher prevalence in the penetrating trauma group (30.3% vs 17.31%). There was also a statistically significant difference between the 2 groups with respect to surgical fixation (P = .003), with a higher rate of surgery in the blunt trauma group (89% vs 75%). The blunt trauma group was demographically matched to the penetrating trauma group with the underlying criterion being long bone fracture. The specific long bone injury was not matched between the 2 groups. Evaluation of the data showed a higher percentage of upper extremity fractures in the penetrating trauma group (38%) than in the blunt trauma group (29%). On further inspection, we found that 21% of the penetrating trauma group had humerus fractures, for which only 48% underwent surgery. In comparison, only 5.8% of the blunt trauma group had humerus fractures, for which 83% underwent surgery. This variation in long bone distribution between the 2 groups explains our finding a higher propensity for surgical fixation in the blunt trauma group (89%) compared with the penetrating trauma group (75%).

 

Discussion

Trauma outcomes historically have been difficult to determine because of lack of patient follow-up. In a simulation series, Zelle and colleagues³ found that the turning point from significant to nonsignificant varied from 15% to 75% loss of follow-up, thus compromising the validity of a study. They and others have emphasized the importance of establishing research protocols to minimize follow-up loss and eliminate reporting bias, ensure randomization, and report accurate outcomes.^3-7

Very few have tried to investigate factors associated with failure to follow up after trauma.^1,2,4 Leukhardt and colleagues⁴ evaluated the medical services that trauma patients follow up with most often. Orthopedic surgery had the largest portion of follow-up visits (37%), followed by the trauma surgery clinic and the emergency department (19% each). The authors also found that penetrating trauma patients were more likely to follow up, though more than 90% of the authors’ patients had blunt trauma. Although our study did not support their finding, it does call into question the commonly held belief that penetrating trauma patients are less likely to follow up, as our study found no difference in follow-up between penetrating and blunt trauma patients.

One of the most interesting findings in this retrospective study is that almost 80% of patients were lost to follow-up regardless of mechanism of injury. Most prospective studies try to reduce loss to follow-up to below 10%. This difference may be attributable to having a dedicated research team and the resources required to ensure follow-up of research patients to improve follow-up beyond baseline values. At our institution, 13 prospective studies (most multicenter) are currently enrolling patients, and the worst loss to follow-up has been 30%. The majority of the studies have loss to follow-up of 15% or less. This low rate represents a significant difference from the 80% “baseline” clinical loss to follow-up for the blunt and penetrating trauma patients treated at our institution, based on the findings of this study. We have been improving follow-up by having dedicated research coordinators call patients to remind them of their appointments (all clinic patients who are not research patients receive a recorded reminder); by having the hospital agree that research patients can be seen without charge (by the facility or the physician), which helps defray costs to the patient; and by excluding patients the principal investigator thinks are unlikely to follow up. Patients unlikely to follow up are routinely excluded by all centers that enroll in prospective studies. Although it is difficult to quantitate, this factor may play a large role in reducing loss to follow-up. Penetrating trauma patients historically routinely biased investigators to exclude them from studies, regardless of whether being considered unlikely to follow-up was an exclusion criterion. Our study results suggest this bias may not be valid.

Our study evaluated the role of mechanism of injury, penetrating or blunt trauma, and the respective orthopedic follow-up. There was no statistically significant difference in the 1-year follow-up rate based on the mechanism of injury. Our study was conducted with a well-matched control group that eliminated potential confounding variables, such as sex, race, age, tobacco use, and alcohol use. Although the prevalence of drug use was higher in the penetrating trauma group, patient retention seemed not to be affected by it. Surprisingly, patient loss to follow-up was extremely high (almost 80%) for both the penetrating and blunt trauma patient groups at the 1-year mark. Our findings call into question the commonly accepted theory that patients with penetrating injuries are less likely to follow up, at least in an academic level I trauma center population. We suggest that the commonly held belief that penetrating trauma patients are less likely to follow up may not be valid and that, when prospective studies are designed, it may not be appropriate to exclude penetrating trauma patients on this basis alone.

The primary limitation of this study is that it was performed at a single institution. Eighty-five percent of blunt trauma patients and 93% of penetrating trauma patients live in the county that is predominantly served by our institution, and electronic medical records from all major hospitals in the metropolitan area are linked, suggesting that the large majority of patients lost to follow-up do not seek further medical care, at least not from local facilities in our metropolitan area. A prospective multicenter study is being designed to help us gain a better understanding of the variables that affect musculoskeletal trauma patient follow-up and learn interventional strategies that can be used to improve patient retention.

Dr. Turner is an Orthopedic Surgeon, Rockwood Clinic, Spokane, Washington. Dr. Turner was a resident at the time the article was written. Dr. Hiatt is an Anesthesia Resident, University of Louisville Department of Anesthesiology and Perioperative Medicine, Louisville, Kentucky. Dr. Mullis is Chief of the Orthopaedic Trauma Service, Eskenazi Health, and Professor & Program Director, Indiana University School of Medicine Department of Orthopaedics, Indianapolis, Indiana.

Acknowledgments: This study was first reported in a poster presentation at the annual meeting of the Orthopaedic Trauma Association, October 2013, Phoenix, Arizona.

The authors gratefully acknowledge and thank Jyoti Sarkar, PhD, for his assistance with statistical analysis and manuscript preparation.

Am J Orthop. 2016;45(6):E331-E334. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

ANNAPOLIS, MD. – Three novel treatments for gonorrhea, currently in late stages of development, could give clinicians an edge in the fight against antibacterial resistance, according to a federal health official.

The pathogen Neisseria gonorrhoeae is already showing signs of besting first-line therapy ceftriaxone in Japan and parts of Europe, said Carolyn Deal, PhD, chief of the sexually transmitted diseases branch at the National Institute of Allergy and Infectious Diseases (NIAID). And the Centers for Disease Control and Prevention lists N. gonorrhoeae among its “urgent” antibiotic resistance threats.

“I think we have a new superbug,” Dr. Deal said at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “In my opinion, it’s just a matter of time in this country.”

But three agents in late-stage clinical trials for uncomplicated urogenital gonorrhea offer promise in fighting the gram-negative bacteria, according to Dr. Deal. The first is solithromycin, manufactured by Cempra. The company has a phase III study underway to compare a single dose of oral solithromycin with intramuscular ceftriaxone plus oral azithromycin for urogenital gonorrhea.

The other two drugs are first-in-class antibacterial agents. In partnership with the NIAID, the company Entasis recently completed a phase II study of zoliflodacin, an oral agent in a novel class of topoisomerase inhibitors. A phase III trial is expected to begin in 2017, also in partnership with the NIAID, according to an Entasis document. The third agent is gepotidacin, a novel triazaacenaphthylene antibacterial agent currently being investigated by GlaxoSmithKline in a phase II study.

Centers for Disease Control and Prevention

Because N. gonorrhoeae poses such an urgent threat, waiting to develop a vaccine is less feasible than working with companies to develop additional antibacterial agents, Dr. Deal said. But taking a compound out of the basic research lab and having enough data to get into the investigational new drug phase is a significant investment, she said, so pharmaceutical manufacturers look for as many indications for a drug as possible.

For instance, solithromycin was initially investigated for community-acquired pneumonia. Gepotidacin initially was developed in partnership with the NIAID and the Biomedical Advanced Research and Development Authority in case of an anthrax attack, Dr. Deal said. “The Entasis product is the only one specifically developed for Neisseria gonorrhoeae,” she said.

One reason that two of the drugs in the pipeline include N. gonorrhoeae as an indication is that the Food and Drug Administration has issued guidance on developing drugs in the area of uncomplicated gonorrhea. That guidance is lacking for nasopharyngeal and rectal gonorrhea, leaving a “vacuum” in the pipeline, Dr. Deal said. “Many of us have come to the conclusion that developing vaccines is the only real long-term solution.”

[email protected]

On Twitter @whitneymcknight

ANNAPOLIS, MD. – Three novel treatments for gonorrhea, currently in late stages of development, could give clinicians an edge in the fight against antibacterial resistance, according to a federal health official.

The pathogen Neisseria gonorrhoeae is already showing signs of besting first-line therapy ceftriaxone in Japan and parts of Europe, said Carolyn Deal, PhD, chief of the sexually transmitted diseases branch at the National Institute of Allergy and Infectious Diseases (NIAID). And the Centers for Disease Control and Prevention lists N. gonorrhoeae among its “urgent” antibiotic resistance threats.

“I think we have a new superbug,” Dr. Deal said at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “In my opinion, it’s just a matter of time in this country.”

But three agents in late-stage clinical trials for uncomplicated urogenital gonorrhea offer promise in fighting the gram-negative bacteria, according to Dr. Deal. The first is solithromycin, manufactured by Cempra. The company has a phase III study underway to compare a single dose of oral solithromycin with intramuscular ceftriaxone plus oral azithromycin for urogenital gonorrhea.

The other two drugs are first-in-class antibacterial agents. In partnership with the NIAID, the company Entasis recently completed a phase II study of zoliflodacin, an oral agent in a novel class of topoisomerase inhibitors. A phase III trial is expected to begin in 2017, also in partnership with the NIAID, according to an Entasis document. The third agent is gepotidacin, a novel triazaacenaphthylene antibacterial agent currently being investigated by GlaxoSmithKline in a phase II study.

Centers for Disease Control and Prevention

Because N. gonorrhoeae poses such an urgent threat, waiting to develop a vaccine is less feasible than working with companies to develop additional antibacterial agents, Dr. Deal said. But taking a compound out of the basic research lab and having enough data to get into the investigational new drug phase is a significant investment, she said, so pharmaceutical manufacturers look for as many indications for a drug as possible.

For instance, solithromycin was initially investigated for community-acquired pneumonia. Gepotidacin initially was developed in partnership with the NIAID and the Biomedical Advanced Research and Development Authority in case of an anthrax attack, Dr. Deal said. “The Entasis product is the only one specifically developed for Neisseria gonorrhoeae,” she said.

One reason that two of the drugs in the pipeline include N. gonorrhoeae as an indication is that the Food and Drug Administration has issued guidance on developing drugs in the area of uncomplicated gonorrhea. That guidance is lacking for nasopharyngeal and rectal gonorrhea, leaving a “vacuum” in the pipeline, Dr. Deal said. “Many of us have come to the conclusion that developing vaccines is the only real long-term solution.”

[email protected]

On Twitter @whitneymcknight

ANNAPOLIS, MD. – Three novel treatments for gonorrhea, currently in late stages of development, could give clinicians an edge in the fight against antibacterial resistance, according to a federal health official.

The pathogen Neisseria gonorrhoeae is already showing signs of besting first-line therapy ceftriaxone in Japan and parts of Europe, said Carolyn Deal, PhD, chief of the sexually transmitted diseases branch at the National Institute of Allergy and Infectious Diseases (NIAID). And the Centers for Disease Control and Prevention lists N. gonorrhoeae among its “urgent” antibiotic resistance threats.

“I think we have a new superbug,” Dr. Deal said at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “In my opinion, it’s just a matter of time in this country.”

But three agents in late-stage clinical trials for uncomplicated urogenital gonorrhea offer promise in fighting the gram-negative bacteria, according to Dr. Deal. The first is solithromycin, manufactured by Cempra. The company has a phase III study underway to compare a single dose of oral solithromycin with intramuscular ceftriaxone plus oral azithromycin for urogenital gonorrhea.

The other two drugs are first-in-class antibacterial agents. In partnership with the NIAID, the company Entasis recently completed a phase II study of zoliflodacin, an oral agent in a novel class of topoisomerase inhibitors. A phase III trial is expected to begin in 2017, also in partnership with the NIAID, according to an Entasis document. The third agent is gepotidacin, a novel triazaacenaphthylene antibacterial agent currently being investigated by GlaxoSmithKline in a phase II study.

Centers for Disease Control and Prevention

Because N. gonorrhoeae poses such an urgent threat, waiting to develop a vaccine is less feasible than working with companies to develop additional antibacterial agents, Dr. Deal said. But taking a compound out of the basic research lab and having enough data to get into the investigational new drug phase is a significant investment, she said, so pharmaceutical manufacturers look for as many indications for a drug as possible.

For instance, solithromycin was initially investigated for community-acquired pneumonia. Gepotidacin initially was developed in partnership with the NIAID and the Biomedical Advanced Research and Development Authority in case of an anthrax attack, Dr. Deal said. “The Entasis product is the only one specifically developed for Neisseria gonorrhoeae,” she said.

One reason that two of the drugs in the pipeline include N. gonorrhoeae as an indication is that the Food and Drug Administration has issued guidance on developing drugs in the area of uncomplicated gonorrhea. That guidance is lacking for nasopharyngeal and rectal gonorrhea, leaving a “vacuum” in the pipeline, Dr. Deal said. “Many of us have come to the conclusion that developing vaccines is the only real long-term solution.”

[email protected]

On Twitter @whitneymcknight

As the United States becomes increasingly diverse, with predictions that by 2045 minorities will comprise 50% or more of the population,¹ the demographics of the orthopedic surgery population will also likely diversify. It is important that orthopedic surgeons shift in their diversity as well. Lack of diversity in orthopedics (women and racial minorities are underrepresented) relative to the national population and other surgical specialties and their training programs is well documented.^2-8

More concerning, the diversity of orthopedic residents does not compare favorably with that of medical school attendees.^4,9 The difference suggests the greatest loss of potential diversity occurs during the transition from medical school to residency. A national study demonstrated that instruction in musculoskeletal medicine led to an increase in application rates nationally.¹⁰ However, the authors of that study stated they were unexpectedly limited by its large size—they could not validate the accuracy of curriculum data and could not differentiate between a 1-day required experience and a 4-week rotation.

In the present study, which accounted for curricular factors, we compared our medical students’ application rates to orthopedics residencies based on sex and race before and after introduction of a required third-year musculoskeletal clerkship. We hypothesized that making the curriculum a requirement would increase the number of applicants and increase the diversity of applicants in terms of both women and underrepresented minorities. This hypothesis was based on the rationale that these groups might not consider an orthopedics residency without first being directly exposed to orthopedics. We also wanted to determine what factors influenced applicants to choose orthopedic surgery.

Methods

Curriculum

Before 2006, third-year students spent 3 months completing a surgery clerkship. Some students interested in orthopedic surgery would have to wait until their fourth year to complete an elective in orthopedic surgery, and uninterested students would not be exposed at all. Starting in 2006, 1 month of the third-year surgery clerkship was required to be completed in musculoskeletal surgery: orthopedic surgery, plastic surgery, or neurosurgical spine. Plastic surgery was an option, as it exposed students to hand surgery and flap reconstruction.

The orthopedic surgery curriculum included two 2-week experiences with an orthopedic surgeon (Table 1), twice-weekly lectures by orthopedics faculty, weekly physical examination sessions, and 3 or 4 nights of call.

During the 12-year study period, overall teaching hours in the preclinical curriculum did not change, and there were no other structural changes to the preclinical or clinical curriculum. The orthopedics department increased its faculty from 23 in 2000 to 34 in 2012. Number of female faculty increased from 1 to 3, representing a 4% to 9% increase in department faculty. Throughout the 12 years, there were no underrepresented minority faculty. Total number of residents increased from 26 in 2000 to 30 in 2012. Number of female residents varied year to year, from a low of 3 in the period 2003–2004 to a high of 11 in the period 2009–2010. Number of underrepresented minority residents varied yearly as well, from 1 to 2.

Data Collection

After this study was granted exempt status by our Institutional Review Board, we obtained student data from our registrar. Data included graduation year, self-identified sex and race, exposure to orthopedic surgery during clerkships, and matching residency specialty. National data were obtained from the Electronic Residency Application Service for the periods 2002–2007 and 2009–2012. These data included all US allopathic medical students’ self-identified sex and race, and applied-to primary residency specialty. National data from 2008 and national data on sex differences in orthopedic applications from 2009 were not available.

Graduates who matched into orthopedic surgery were asked to complete an anonymous survey on what influenced their decision to apply to orthopedic surgery and when this decision was made. Our goal with the survey was to substantiate or refute the conclusion that application rates depended on third-year exposure to musculoskeletal medicine.

Statistical Methods

Students were divided into 2 groups: precurriculum (graduated within 7-year period, 2000–2006) and postcurriculum (graduated within 6-year period, 2007–2012). A 2-sample test for proportions was used to compare percentage of total students who applied to orthopedics in each group. In the group of students who applied to orthopedics, we compared precurriculum and postcurriculum proportions of women and underrepresented minorities (non-white, non-Asian). We also compared these proportions with national data (using 2-sample tests for proportions) to determine if any change in diversity of our institution’s applicants was mirroring a national trend. Our definition of underrepresented minority was based on work that showed that the proportion of Asian matriculants in medical school and the proportion of applicants to orthopedics are higher than their respective national proportions.⁵ Survey data are reported descriptively. Statistical significance was defined with a 2-tailed α of 0.05 for all tests.

 

Results

Over the 2000–2012 period, 1507 students from our institution successfully applied to residency programs: 792 in the precurriculum group and 715 in the postcurriculum group. Of these students, 91 successfully applied to orthopedic surgery: 48 in the precurriculum group (applied before introduction of the required clerkship) and 43 in the postcurriculum group (applied afterward).

Each cohort represented 6% of the total number of students. Table 2 lists the groups’ demographics.

Over the 2002–2012 period, 10,100 US allopathic medical students applied to orthopedic residency programs: 4769 students between 2002 and 2006 and 5331 students between 2007 and 2012.

Table 3 lists these groups’ demographics.

Before the musculoskeletal clerkship was required, 317 (40%) of the 792 precurriculum students were exposed to orthopedics during their third year. During this period, 42 of the 48 orthopedic surgery applicants completed an orthopedic surgery rotation during their third year of medical school. After the clerkship was required, 465 (65%) of the 715 postcurriculum students were exposed to orthopedics during their third year, including all 43 orthopedic surgery applicants (100% of students were exposed to musculoskeletal surgery, including plastic surgery and neurologic spine). The 25% increase in exposure to orthopedic surgery during the third year was statistically significant (P < .0001), but there was no resultant increase in overall percentage of students applying to orthopedic residencies (6% in each case; P = .98).

Over the 12-year study period, the proportion of female medical students at our institution declined from 50% (395/792) to 46% (328/715) (P = .13). However, there was an 81% relative increase, from 17% (8/48) before introduction of the clerkship to 30% (13/43) afterward, in the proportion of female applicants to orthopedic surgery. This contrasted with national data showing the percentage of female applicants to orthopedic surgery remained stable from 2002–2006 (14%, 675/4758) to 2007–2012 (15%, 643/4277). Before the clerkship was required, the proportion of female applicants from our institution was similar to national rates (P = .50). Afterward, our institution produced a significantly higher proportion of female applicants compared with the national proportion (P = .026).

Over the 12-year period, our self-identified underrepresented minority medical student population increased significantly (P = .02), from 13% (103/792) to 17% (124/715). The relative proportion of underrepresented minority orthopedic surgery applicants increased by 101%, from 10% (5/48) before the clerkship was required to 21% (9/43) afterward. Nationally, over the same period, underrepresented minorities’ orthopedic surgery application rates increased significantly (P < .001), from 16% (763/4769) to 19% (1002/5331). The proportion of underrepresented racial minorities that applied did not differ significantly between our institution and nationally for the years either before (P = .97) or after (P = .68) introduction of the curriculum.

Surveys were completed by 58 (64%) of 91 graduates (21 women, 70 men). Respondents’ characteristics are listed in Table 4.

Eighteen (86%) of the 21 female graduates completed the survey: 6 (75%) of 8 precurriculum and 12 (92%) of 13 postcurriculum. Only 5 (36%) of 14 underrepresented minorities completed the survey, all postcurriculum. Of the 28 precurriculum respondents, 22 (79%) decided to apply to orthopedic surgery during their third or fourth year, and this was true for 25 (83%) of 30 postcurriculum respondents. Of all 58 respondents, 51 (88%) indicated that their third-year rotation in musculoskeletal medicine influenced their choice of specialty. Specifically, 3 precurriculum respondents (1 female) had no interest in orthopedic surgery until their third-year experience. By contrast, 7 postcurriculum students (5 females/minorities) had no prior interest in orthopedics—they chose to pursue the specialty after their orthopedic rotation.

Discussion

Orthopedic surgery needs a more diverse workforce^11-17 in order to better mirror the population served, bring care to underserved areas,^18-26 and provide better training environments.²⁷ Several hypotheses about the lack of diversity have been posited: stereotypes about the specialty,^28-31 lack of interest among minority medical students, and lack of exposure to the specialty.^5,6,32,33

Lack of exposure deserves scrutiny, as a large proportion of medical students who choose to apply to orthopedic surgery make their decision before entering medical school, which is not typical.³³ Such a finding suggests that exposure to orthopedic surgery is lacking, especially given that an orthopedic surgery rotation is usually not required during the clinical years. The idea that increased exposure to orthopedics affects application patterns is logical, as clinical exposure has been shown to play a role in medical students’ choice of specialty.³⁴

Exposure helps in several key areas. Firsthand experience can help dispel stereotypes, such as the idea that success in orthopedic surgery depends on physical strength and that only former athletes pursue orthopedics.^28-31 Authors have also reported on a perceived negative bias against women: Orthopedics is an “old boys’ network”; women will not fit in and need not apply; the orthopedic lifestyle is difficult and not conducive to a satisfying personal life.⁹ Requiring exposure ensures that all students, but especially women, can gain firsthand experience that can show these stereotypes to be false. Beyond dispelling these stereotypes, exposure to orthopedic surgery is essential for women, as studies have shown that clinical rotations play a larger role in determining specialty choice for women compared to men,³³ and this would be particularly critical for specialties they may not be initially considering.

A national study found that requiring an orthopedic/musculoskeletal clerkship led to a 12% relative increase in the application rate, from 5.1% to 5.7%, and to an increase in applicant diversity (race, sex).¹⁰ However, the investigators could not determine individual reasons for specialty choice or the exact nature of each institution’s musculoskeletal curriculum. Confirming these factors, we found an 81% increase in number of female applicants and a 101% increase in number of underrepresented minority applicants after introduction of the required third-year musculoskeletal surgery clerkship at our institution.

We were unable to replicate the 12% relative increase in the overall application rate; our orthopedic surgery match rate remained 6%. Our findings cannot directly explain this, but we have several hypotheses. First, whereas other studies measured the application rate, we measured the successful match rate, given our data structure. This difference in data definition could account for some of the discrepancy. Second, we did not account for individuals’ academic success, and career counseling is paramount in decisions regarding residency specialties. It is possible we are substituting qualified female and underrepresented minority candidates for less-than-qualified male applicants. Third, the 25% increase in medical student exposure to orthopedic surgery led to a corresponding increase in number of orthopedic faculty providing undergraduate medical education. Some of these faculty could have been inexperienced in undergraduate medical education, and thus the teaching environment may not have been optimal.

Our study had several limitations. First, our institution has limited racial diversity. Over the past 12 years, only 15% of our students have been underrepresented minorities. (Nationally, the proportion is closer to 18%.) This may have limited the ability of our orthopedic rotation to affect the proportion of underrepresented minority applicants. Second, this study involved medical students at only one institution, which limits generalizability of findings. Third, we were unable to obtain records specifying which faculty and residents interacted with which medical students, and the increased number of female faculty and residents coinciding with the curriculum change may also be a factor. However, we expect that, without the curriculum change, these students would have had smaller odds of interacting with these potential female role models in orthopedics, negating any affect they may have had. Last, although we contacted former students to ask about their reasons for choosing the orthopedics residency, those findings are limited by a potential respondent selection bias.

The qualities and characteristics of successful orthopedic surgeons, as presented in both medical and lay cultures, are subject to numerous stereotypes. By increasing medical student exposure to orthopedics during the third year of medical school, we are giving a larger proportion of our students direct clinical experience in a field they may not have been considering. This exposure allows students to interact with mentors who can be positive role models—orthopedic surgeons who are dispelling stereotypes. By increasing medical student exposure and reaching students who may not have been considering orthopedics, we have increased diversity among our applicants. Third-year medical students’ exposure to orthopedic surgery is essential in promoting a more diverse workforce.

Am J Orthop. 2016;45(6):E347-E351. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

As the United States becomes increasingly diverse, with predictions that by 2045 minorities will comprise 50% or more of the population,¹ the demographics of the orthopedic surgery population will also likely diversify. It is important that orthopedic surgeons shift in their diversity as well. Lack of diversity in orthopedics (women and racial minorities are underrepresented) relative to the national population and other surgical specialties and their training programs is well documented.^2-8

More concerning, the diversity of orthopedic residents does not compare favorably with that of medical school attendees.^4,9 The difference suggests the greatest loss of potential diversity occurs during the transition from medical school to residency. A national study demonstrated that instruction in musculoskeletal medicine led to an increase in application rates nationally.¹⁰ However, the authors of that study stated they were unexpectedly limited by its large size—they could not validate the accuracy of curriculum data and could not differentiate between a 1-day required experience and a 4-week rotation.

In the present study, which accounted for curricular factors, we compared our medical students’ application rates to orthopedics residencies based on sex and race before and after introduction of a required third-year musculoskeletal clerkship. We hypothesized that making the curriculum a requirement would increase the number of applicants and increase the diversity of applicants in terms of both women and underrepresented minorities. This hypothesis was based on the rationale that these groups might not consider an orthopedics residency without first being directly exposed to orthopedics. We also wanted to determine what factors influenced applicants to choose orthopedic surgery.

Methods

Curriculum

Before 2006, third-year students spent 3 months completing a surgery clerkship. Some students interested in orthopedic surgery would have to wait until their fourth year to complete an elective in orthopedic surgery, and uninterested students would not be exposed at all. Starting in 2006, 1 month of the third-year surgery clerkship was required to be completed in musculoskeletal surgery: orthopedic surgery, plastic surgery, or neurosurgical spine. Plastic surgery was an option, as it exposed students to hand surgery and flap reconstruction.

The orthopedic surgery curriculum included two 2-week experiences with an orthopedic surgeon (Table 1), twice-weekly lectures by orthopedics faculty, weekly physical examination sessions, and 3 or 4 nights of call.

During the 12-year study period, overall teaching hours in the preclinical curriculum did not change, and there were no other structural changes to the preclinical or clinical curriculum. The orthopedics department increased its faculty from 23 in 2000 to 34 in 2012. Number of female faculty increased from 1 to 3, representing a 4% to 9% increase in department faculty. Throughout the 12 years, there were no underrepresented minority faculty. Total number of residents increased from 26 in 2000 to 30 in 2012. Number of female residents varied year to year, from a low of 3 in the period 2003–2004 to a high of 11 in the period 2009–2010. Number of underrepresented minority residents varied yearly as well, from 1 to 2.

Data Collection

After this study was granted exempt status by our Institutional Review Board, we obtained student data from our registrar. Data included graduation year, self-identified sex and race, exposure to orthopedic surgery during clerkships, and matching residency specialty. National data were obtained from the Electronic Residency Application Service for the periods 2002–2007 and 2009–2012. These data included all US allopathic medical students’ self-identified sex and race, and applied-to primary residency specialty. National data from 2008 and national data on sex differences in orthopedic applications from 2009 were not available.

Graduates who matched into orthopedic surgery were asked to complete an anonymous survey on what influenced their decision to apply to orthopedic surgery and when this decision was made. Our goal with the survey was to substantiate or refute the conclusion that application rates depended on third-year exposure to musculoskeletal medicine.

Statistical Methods

Students were divided into 2 groups: precurriculum (graduated within 7-year period, 2000–2006) and postcurriculum (graduated within 6-year period, 2007–2012). A 2-sample test for proportions was used to compare percentage of total students who applied to orthopedics in each group. In the group of students who applied to orthopedics, we compared precurriculum and postcurriculum proportions of women and underrepresented minorities (non-white, non-Asian). We also compared these proportions with national data (using 2-sample tests for proportions) to determine if any change in diversity of our institution’s applicants was mirroring a national trend. Our definition of underrepresented minority was based on work that showed that the proportion of Asian matriculants in medical school and the proportion of applicants to orthopedics are higher than their respective national proportions.⁵ Survey data are reported descriptively. Statistical significance was defined with a 2-tailed α of 0.05 for all tests.

 

Results

Over the 2000–2012 period, 1507 students from our institution successfully applied to residency programs: 792 in the precurriculum group and 715 in the postcurriculum group. Of these students, 91 successfully applied to orthopedic surgery: 48 in the precurriculum group (applied before introduction of the required clerkship) and 43 in the postcurriculum group (applied afterward).

Each cohort represented 6% of the total number of students. Table 2 lists the groups’ demographics.

Over the 2002–2012 period, 10,100 US allopathic medical students applied to orthopedic residency programs: 4769 students between 2002 and 2006 and 5331 students between 2007 and 2012.

Table 3 lists these groups’ demographics.

Before the musculoskeletal clerkship was required, 317 (40%) of the 792 precurriculum students were exposed to orthopedics during their third year. During this period, 42 of the 48 orthopedic surgery applicants completed an orthopedic surgery rotation during their third year of medical school. After the clerkship was required, 465 (65%) of the 715 postcurriculum students were exposed to orthopedics during their third year, including all 43 orthopedic surgery applicants (100% of students were exposed to musculoskeletal surgery, including plastic surgery and neurologic spine). The 25% increase in exposure to orthopedic surgery during the third year was statistically significant (P < .0001), but there was no resultant increase in overall percentage of students applying to orthopedic residencies (6% in each case; P = .98).

Over the 12-year study period, the proportion of female medical students at our institution declined from 50% (395/792) to 46% (328/715) (P = .13). However, there was an 81% relative increase, from 17% (8/48) before introduction of the clerkship to 30% (13/43) afterward, in the proportion of female applicants to orthopedic surgery. This contrasted with national data showing the percentage of female applicants to orthopedic surgery remained stable from 2002–2006 (14%, 675/4758) to 2007–2012 (15%, 643/4277). Before the clerkship was required, the proportion of female applicants from our institution was similar to national rates (P = .50). Afterward, our institution produced a significantly higher proportion of female applicants compared with the national proportion (P = .026).

Over the 12-year period, our self-identified underrepresented minority medical student population increased significantly (P = .02), from 13% (103/792) to 17% (124/715). The relative proportion of underrepresented minority orthopedic surgery applicants increased by 101%, from 10% (5/48) before the clerkship was required to 21% (9/43) afterward. Nationally, over the same period, underrepresented minorities’ orthopedic surgery application rates increased significantly (P < .001), from 16% (763/4769) to 19% (1002/5331). The proportion of underrepresented racial minorities that applied did not differ significantly between our institution and nationally for the years either before (P = .97) or after (P = .68) introduction of the curriculum.

Surveys were completed by 58 (64%) of 91 graduates (21 women, 70 men). Respondents’ characteristics are listed in Table 4.

Eighteen (86%) of the 21 female graduates completed the survey: 6 (75%) of 8 precurriculum and 12 (92%) of 13 postcurriculum. Only 5 (36%) of 14 underrepresented minorities completed the survey, all postcurriculum. Of the 28 precurriculum respondents, 22 (79%) decided to apply to orthopedic surgery during their third or fourth year, and this was true for 25 (83%) of 30 postcurriculum respondents. Of all 58 respondents, 51 (88%) indicated that their third-year rotation in musculoskeletal medicine influenced their choice of specialty. Specifically, 3 precurriculum respondents (1 female) had no interest in orthopedic surgery until their third-year experience. By contrast, 7 postcurriculum students (5 females/minorities) had no prior interest in orthopedics—they chose to pursue the specialty after their orthopedic rotation.

Discussion

Orthopedic surgery needs a more diverse workforce^11-17 in order to better mirror the population served, bring care to underserved areas,^18-26 and provide better training environments.²⁷ Several hypotheses about the lack of diversity have been posited: stereotypes about the specialty,^28-31 lack of interest among minority medical students, and lack of exposure to the specialty.^5,6,32,33

Lack of exposure deserves scrutiny, as a large proportion of medical students who choose to apply to orthopedic surgery make their decision before entering medical school, which is not typical.³³ Such a finding suggests that exposure to orthopedic surgery is lacking, especially given that an orthopedic surgery rotation is usually not required during the clinical years. The idea that increased exposure to orthopedics affects application patterns is logical, as clinical exposure has been shown to play a role in medical students’ choice of specialty.³⁴

Exposure helps in several key areas. Firsthand experience can help dispel stereotypes, such as the idea that success in orthopedic surgery depends on physical strength and that only former athletes pursue orthopedics.^28-31 Authors have also reported on a perceived negative bias against women: Orthopedics is an “old boys’ network”; women will not fit in and need not apply; the orthopedic lifestyle is difficult and not conducive to a satisfying personal life.⁹ Requiring exposure ensures that all students, but especially women, can gain firsthand experience that can show these stereotypes to be false. Beyond dispelling these stereotypes, exposure to orthopedic surgery is essential for women, as studies have shown that clinical rotations play a larger role in determining specialty choice for women compared to men,³³ and this would be particularly critical for specialties they may not be initially considering.

A national study found that requiring an orthopedic/musculoskeletal clerkship led to a 12% relative increase in the application rate, from 5.1% to 5.7%, and to an increase in applicant diversity (race, sex).¹⁰ However, the investigators could not determine individual reasons for specialty choice or the exact nature of each institution’s musculoskeletal curriculum. Confirming these factors, we found an 81% increase in number of female applicants and a 101% increase in number of underrepresented minority applicants after introduction of the required third-year musculoskeletal surgery clerkship at our institution.

We were unable to replicate the 12% relative increase in the overall application rate; our orthopedic surgery match rate remained 6%. Our findings cannot directly explain this, but we have several hypotheses. First, whereas other studies measured the application rate, we measured the successful match rate, given our data structure. This difference in data definition could account for some of the discrepancy. Second, we did not account for individuals’ academic success, and career counseling is paramount in decisions regarding residency specialties. It is possible we are substituting qualified female and underrepresented minority candidates for less-than-qualified male applicants. Third, the 25% increase in medical student exposure to orthopedic surgery led to a corresponding increase in number of orthopedic faculty providing undergraduate medical education. Some of these faculty could have been inexperienced in undergraduate medical education, and thus the teaching environment may not have been optimal.

Our study had several limitations. First, our institution has limited racial diversity. Over the past 12 years, only 15% of our students have been underrepresented minorities. (Nationally, the proportion is closer to 18%.) This may have limited the ability of our orthopedic rotation to affect the proportion of underrepresented minority applicants. Second, this study involved medical students at only one institution, which limits generalizability of findings. Third, we were unable to obtain records specifying which faculty and residents interacted with which medical students, and the increased number of female faculty and residents coinciding with the curriculum change may also be a factor. However, we expect that, without the curriculum change, these students would have had smaller odds of interacting with these potential female role models in orthopedics, negating any affect they may have had. Last, although we contacted former students to ask about their reasons for choosing the orthopedics residency, those findings are limited by a potential respondent selection bias.

The qualities and characteristics of successful orthopedic surgeons, as presented in both medical and lay cultures, are subject to numerous stereotypes. By increasing medical student exposure to orthopedics during the third year of medical school, we are giving a larger proportion of our students direct clinical experience in a field they may not have been considering. This exposure allows students to interact with mentors who can be positive role models—orthopedic surgeons who are dispelling stereotypes. By increasing medical student exposure and reaching students who may not have been considering orthopedics, we have increased diversity among our applicants. Third-year medical students’ exposure to orthopedic surgery is essential in promoting a more diverse workforce.

Am J Orthop. 2016;45(6):E347-E351. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

As the United States becomes increasingly diverse, with predictions that by 2045 minorities will comprise 50% or more of the population,¹ the demographics of the orthopedic surgery population will also likely diversify. It is important that orthopedic surgeons shift in their diversity as well. Lack of diversity in orthopedics (women and racial minorities are underrepresented) relative to the national population and other surgical specialties and their training programs is well documented.^2-8

More concerning, the diversity of orthopedic residents does not compare favorably with that of medical school attendees.^4,9 The difference suggests the greatest loss of potential diversity occurs during the transition from medical school to residency. A national study demonstrated that instruction in musculoskeletal medicine led to an increase in application rates nationally.¹⁰ However, the authors of that study stated they were unexpectedly limited by its large size—they could not validate the accuracy of curriculum data and could not differentiate between a 1-day required experience and a 4-week rotation.

In the present study, which accounted for curricular factors, we compared our medical students’ application rates to orthopedics residencies based on sex and race before and after introduction of a required third-year musculoskeletal clerkship. We hypothesized that making the curriculum a requirement would increase the number of applicants and increase the diversity of applicants in terms of both women and underrepresented minorities. This hypothesis was based on the rationale that these groups might not consider an orthopedics residency without first being directly exposed to orthopedics. We also wanted to determine what factors influenced applicants to choose orthopedic surgery.

Methods

Curriculum

Before 2006, third-year students spent 3 months completing a surgery clerkship. Some students interested in orthopedic surgery would have to wait until their fourth year to complete an elective in orthopedic surgery, and uninterested students would not be exposed at all. Starting in 2006, 1 month of the third-year surgery clerkship was required to be completed in musculoskeletal surgery: orthopedic surgery, plastic surgery, or neurosurgical spine. Plastic surgery was an option, as it exposed students to hand surgery and flap reconstruction.

The orthopedic surgery curriculum included two 2-week experiences with an orthopedic surgeon (Table 1), twice-weekly lectures by orthopedics faculty, weekly physical examination sessions, and 3 or 4 nights of call.

During the 12-year study period, overall teaching hours in the preclinical curriculum did not change, and there were no other structural changes to the preclinical or clinical curriculum. The orthopedics department increased its faculty from 23 in 2000 to 34 in 2012. Number of female faculty increased from 1 to 3, representing a 4% to 9% increase in department faculty. Throughout the 12 years, there were no underrepresented minority faculty. Total number of residents increased from 26 in 2000 to 30 in 2012. Number of female residents varied year to year, from a low of 3 in the period 2003–2004 to a high of 11 in the period 2009–2010. Number of underrepresented minority residents varied yearly as well, from 1 to 2.

Data Collection

After this study was granted exempt status by our Institutional Review Board, we obtained student data from our registrar. Data included graduation year, self-identified sex and race, exposure to orthopedic surgery during clerkships, and matching residency specialty. National data were obtained from the Electronic Residency Application Service for the periods 2002–2007 and 2009–2012. These data included all US allopathic medical students’ self-identified sex and race, and applied-to primary residency specialty. National data from 2008 and national data on sex differences in orthopedic applications from 2009 were not available.

Graduates who matched into orthopedic surgery were asked to complete an anonymous survey on what influenced their decision to apply to orthopedic surgery and when this decision was made. Our goal with the survey was to substantiate or refute the conclusion that application rates depended on third-year exposure to musculoskeletal medicine.

Statistical Methods

Students were divided into 2 groups: precurriculum (graduated within 7-year period, 2000–2006) and postcurriculum (graduated within 6-year period, 2007–2012). A 2-sample test for proportions was used to compare percentage of total students who applied to orthopedics in each group. In the group of students who applied to orthopedics, we compared precurriculum and postcurriculum proportions of women and underrepresented minorities (non-white, non-Asian). We also compared these proportions with national data (using 2-sample tests for proportions) to determine if any change in diversity of our institution’s applicants was mirroring a national trend. Our definition of underrepresented minority was based on work that showed that the proportion of Asian matriculants in medical school and the proportion of applicants to orthopedics are higher than their respective national proportions.⁵ Survey data are reported descriptively. Statistical significance was defined with a 2-tailed α of 0.05 for all tests.

 

Results

Over the 2000–2012 period, 1507 students from our institution successfully applied to residency programs: 792 in the precurriculum group and 715 in the postcurriculum group. Of these students, 91 successfully applied to orthopedic surgery: 48 in the precurriculum group (applied before introduction of the required clerkship) and 43 in the postcurriculum group (applied afterward).

Each cohort represented 6% of the total number of students. Table 2 lists the groups’ demographics.

Over the 2002–2012 period, 10,100 US allopathic medical students applied to orthopedic residency programs: 4769 students between 2002 and 2006 and 5331 students between 2007 and 2012.

Table 3 lists these groups’ demographics.

Before the musculoskeletal clerkship was required, 317 (40%) of the 792 precurriculum students were exposed to orthopedics during their third year. During this period, 42 of the 48 orthopedic surgery applicants completed an orthopedic surgery rotation during their third year of medical school. After the clerkship was required, 465 (65%) of the 715 postcurriculum students were exposed to orthopedics during their third year, including all 43 orthopedic surgery applicants (100% of students were exposed to musculoskeletal surgery, including plastic surgery and neurologic spine). The 25% increase in exposure to orthopedic surgery during the third year was statistically significant (P < .0001), but there was no resultant increase in overall percentage of students applying to orthopedic residencies (6% in each case; P = .98).

Over the 12-year study period, the proportion of female medical students at our institution declined from 50% (395/792) to 46% (328/715) (P = .13). However, there was an 81% relative increase, from 17% (8/48) before introduction of the clerkship to 30% (13/43) afterward, in the proportion of female applicants to orthopedic surgery. This contrasted with national data showing the percentage of female applicants to orthopedic surgery remained stable from 2002–2006 (14%, 675/4758) to 2007–2012 (15%, 643/4277). Before the clerkship was required, the proportion of female applicants from our institution was similar to national rates (P = .50). Afterward, our institution produced a significantly higher proportion of female applicants compared with the national proportion (P = .026).

Over the 12-year period, our self-identified underrepresented minority medical student population increased significantly (P = .02), from 13% (103/792) to 17% (124/715). The relative proportion of underrepresented minority orthopedic surgery applicants increased by 101%, from 10% (5/48) before the clerkship was required to 21% (9/43) afterward. Nationally, over the same period, underrepresented minorities’ orthopedic surgery application rates increased significantly (P < .001), from 16% (763/4769) to 19% (1002/5331). The proportion of underrepresented racial minorities that applied did not differ significantly between our institution and nationally for the years either before (P = .97) or after (P = .68) introduction of the curriculum.

Surveys were completed by 58 (64%) of 91 graduates (21 women, 70 men). Respondents’ characteristics are listed in Table 4.

Eighteen (86%) of the 21 female graduates completed the survey: 6 (75%) of 8 precurriculum and 12 (92%) of 13 postcurriculum. Only 5 (36%) of 14 underrepresented minorities completed the survey, all postcurriculum. Of the 28 precurriculum respondents, 22 (79%) decided to apply to orthopedic surgery during their third or fourth year, and this was true for 25 (83%) of 30 postcurriculum respondents. Of all 58 respondents, 51 (88%) indicated that their third-year rotation in musculoskeletal medicine influenced their choice of specialty. Specifically, 3 precurriculum respondents (1 female) had no interest in orthopedic surgery until their third-year experience. By contrast, 7 postcurriculum students (5 females/minorities) had no prior interest in orthopedics—they chose to pursue the specialty after their orthopedic rotation.

Discussion

Orthopedic surgery needs a more diverse workforce^11-17 in order to better mirror the population served, bring care to underserved areas,^18-26 and provide better training environments.²⁷ Several hypotheses about the lack of diversity have been posited: stereotypes about the specialty,^28-31 lack of interest among minority medical students, and lack of exposure to the specialty.^5,6,32,33

Lack of exposure deserves scrutiny, as a large proportion of medical students who choose to apply to orthopedic surgery make their decision before entering medical school, which is not typical.³³ Such a finding suggests that exposure to orthopedic surgery is lacking, especially given that an orthopedic surgery rotation is usually not required during the clinical years. The idea that increased exposure to orthopedics affects application patterns is logical, as clinical exposure has been shown to play a role in medical students’ choice of specialty.³⁴

Exposure helps in several key areas. Firsthand experience can help dispel stereotypes, such as the idea that success in orthopedic surgery depends on physical strength and that only former athletes pursue orthopedics.^28-31 Authors have also reported on a perceived negative bias against women: Orthopedics is an “old boys’ network”; women will not fit in and need not apply; the orthopedic lifestyle is difficult and not conducive to a satisfying personal life.⁹ Requiring exposure ensures that all students, but especially women, can gain firsthand experience that can show these stereotypes to be false. Beyond dispelling these stereotypes, exposure to orthopedic surgery is essential for women, as studies have shown that clinical rotations play a larger role in determining specialty choice for women compared to men,³³ and this would be particularly critical for specialties they may not be initially considering.

A national study found that requiring an orthopedic/musculoskeletal clerkship led to a 12% relative increase in the application rate, from 5.1% to 5.7%, and to an increase in applicant diversity (race, sex).¹⁰ However, the investigators could not determine individual reasons for specialty choice or the exact nature of each institution’s musculoskeletal curriculum. Confirming these factors, we found an 81% increase in number of female applicants and a 101% increase in number of underrepresented minority applicants after introduction of the required third-year musculoskeletal surgery clerkship at our institution.

We were unable to replicate the 12% relative increase in the overall application rate; our orthopedic surgery match rate remained 6%. Our findings cannot directly explain this, but we have several hypotheses. First, whereas other studies measured the application rate, we measured the successful match rate, given our data structure. This difference in data definition could account for some of the discrepancy. Second, we did not account for individuals’ academic success, and career counseling is paramount in decisions regarding residency specialties. It is possible we are substituting qualified female and underrepresented minority candidates for less-than-qualified male applicants. Third, the 25% increase in medical student exposure to orthopedic surgery led to a corresponding increase in number of orthopedic faculty providing undergraduate medical education. Some of these faculty could have been inexperienced in undergraduate medical education, and thus the teaching environment may not have been optimal.

Our study had several limitations. First, our institution has limited racial diversity. Over the past 12 years, only 15% of our students have been underrepresented minorities. (Nationally, the proportion is closer to 18%.) This may have limited the ability of our orthopedic rotation to affect the proportion of underrepresented minority applicants. Second, this study involved medical students at only one institution, which limits generalizability of findings. Third, we were unable to obtain records specifying which faculty and residents interacted with which medical students, and the increased number of female faculty and residents coinciding with the curriculum change may also be a factor. However, we expect that, without the curriculum change, these students would have had smaller odds of interacting with these potential female role models in orthopedics, negating any affect they may have had. Last, although we contacted former students to ask about their reasons for choosing the orthopedics residency, those findings are limited by a potential respondent selection bias.

The qualities and characteristics of successful orthopedic surgeons, as presented in both medical and lay cultures, are subject to numerous stereotypes. By increasing medical student exposure to orthopedics during the third year of medical school, we are giving a larger proportion of our students direct clinical experience in a field they may not have been considering. This exposure allows students to interact with mentors who can be positive role models—orthopedic surgeons who are dispelling stereotypes. By increasing medical student exposure and reaching students who may not have been considering orthopedics, we have increased diversity among our applicants. Third-year medical students’ exposure to orthopedic surgery is essential in promoting a more diverse workforce.

Am J Orthop. 2016;45(6):E347-E351. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.