Earlier this week, an airplane headed from Barcelona to Dusseldorf crashed into the French Alps, leaving 150 people dead. The black box recorder indicated that the copilot was left alone in the cockpit, the pilot was locked out and attempted to gain re-entry, and the flight was reprogrammed to cruise at an altitude of 100 feet, causing the plane to crash after an 8-minute descent. The evidence indicates a deliberate action on the part of the 27-year-old co-pilot, Andreas Lubitz.

With nothing to point to terrorism at this point, the investigation will include the question of whether or not the copilot suffered from a mental illness as a way of explaining his unexplainable actions. In short, was this a combination mass murder/suicide? Was there any way to predict that such an atrocity might happen? Are there measures that can be taken to ensure that it doesn’t happen again?

In the United States, treatment with any psychotropic medication has been a reason to ground a pilot permanently. In April 2010, the Federal Aviation Administration’s rules changed such that a pilot could fly if he’d been treated for mild to moderate depression with a selective serotonin reuptake inhibitor after 12 months. At that time, the FAA announced a 6-month amnesty period where a pilot could come forward about a diagnosis of depression that he had not previously felt comfortable disclosing. Presumably, other countries also have rules that ground pilots for mental illness.

So far, some reports in the media indicate that the copilot was not obviously suffering from a psychiatric disorder; all those who have been interviewed for these reports have expressed shock that Lubitz might have deliberately crashed the plane.

There also has been speculation in the media that a break in the copilot’s training 6 years ago was due to depression, and the mother of a school mate reportedly said that Lubitz had been treated for depression. Finally, investigators found a doctor’s note excusing Lubitz from work. At this point, the Wall Street Journal is reporting that he was being treated for depression. Apparently, he had shredded the note and flew on Tuesday, despite the written work excuse.

Still, all discussion of the copilot’s mental state is purely speculation. The media is noted for sensationalist reporting – and in efforts to get information out quickly, the details are often confused or simply wrong, sometimes to a remarkable extent. We don’t know if the work excuse was written by a psychiatrist or another type of physician; we don’t know if it was for a psychiatric condition, cancer, or simply strep throat.

What we’ve been told is that a copilot who was cleared to fly did so despite a work excuse from a physician, he did not disclose this condition to his employer, and he crashed a plane killing 150 people.

We might assume that the pilot suffered from some type of psychic distress – whether he met criteria for a mental disorder or not, it’s not normal to kill 150 people. If the pilot did have a history of depression and was being treated at the time of this week’s flight, then we may be left with a very unsatisfactory answer.

The anti-psychiatry activists will say that psychotropic medications caused Lubitz to crash the plane. Psychiatrists will be left with no great answer with such a scenario and will be left to say that whatever treatment he was receiving, it wasn’t enough. Certainly, the physician who told Lubitz to take off from work was right: He didn’t belong in a cockpit that day. Presumably, that physician would have done more had he been aware that the patient was about to commit a mass murder.

If the copilot does have a history of depression, but his current work excuse was for an unrelated condition, we might wonder if an untreated recurrence of depression played some role in his actions. One might speculate that the copilot could have been afraid to seek care at this time, perhaps because of a fear that he would lose his vocation.

Still, major depression can hardly explain such an act, and it is unfortunate that the press has already begun to run headlines linking this man’s alleged psychiatric diagnosis to a catastrophic mass murder. Somehow, “mental illness” gets used as an endpoint explanation for why such things happen; and short of a severe psychotic delusional system, it’s a very unsatisfying answer for an unprecedented act of violence.

The facts will unfold and perhaps we’ll learn a little more. We’ll find out what condition the copilot was being treated for and whether there were other stresses going on in his personal life. But people get depressed, take antidepressants, and deal with stress all the time.

It’s possible, if not likely, that we’ll never understand why this copilot decided to end the lives of so many people along with his own.

Dr. Miller is a coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work (Baltimore: The Johns Hopkins University, 2011).

Earlier this week, an airplane headed from Barcelona to Dusseldorf crashed into the French Alps, leaving 150 people dead. The black box recorder indicated that the copilot was left alone in the cockpit, the pilot was locked out and attempted to gain re-entry, and the flight was reprogrammed to cruise at an altitude of 100 feet, causing the plane to crash after an 8-minute descent. The evidence indicates a deliberate action on the part of the 27-year-old co-pilot, Andreas Lubitz.

With nothing to point to terrorism at this point, the investigation will include the question of whether or not the copilot suffered from a mental illness as a way of explaining his unexplainable actions. In short, was this a combination mass murder/suicide? Was there any way to predict that such an atrocity might happen? Are there measures that can be taken to ensure that it doesn’t happen again?

In the United States, treatment with any psychotropic medication has been a reason to ground a pilot permanently. In April 2010, the Federal Aviation Administration’s rules changed such that a pilot could fly if he’d been treated for mild to moderate depression with a selective serotonin reuptake inhibitor after 12 months. At that time, the FAA announced a 6-month amnesty period where a pilot could come forward about a diagnosis of depression that he had not previously felt comfortable disclosing. Presumably, other countries also have rules that ground pilots for mental illness.

So far, some reports in the media indicate that the copilot was not obviously suffering from a psychiatric disorder; all those who have been interviewed for these reports have expressed shock that Lubitz might have deliberately crashed the plane.

There also has been speculation in the media that a break in the copilot’s training 6 years ago was due to depression, and the mother of a school mate reportedly said that Lubitz had been treated for depression. Finally, investigators found a doctor’s note excusing Lubitz from work. At this point, the Wall Street Journal is reporting that he was being treated for depression. Apparently, he had shredded the note and flew on Tuesday, despite the written work excuse.

Still, all discussion of the copilot’s mental state is purely speculation. The media is noted for sensationalist reporting – and in efforts to get information out quickly, the details are often confused or simply wrong, sometimes to a remarkable extent. We don’t know if the work excuse was written by a psychiatrist or another type of physician; we don’t know if it was for a psychiatric condition, cancer, or simply strep throat.

What we’ve been told is that a copilot who was cleared to fly did so despite a work excuse from a physician, he did not disclose this condition to his employer, and he crashed a plane killing 150 people.

We might assume that the pilot suffered from some type of psychic distress – whether he met criteria for a mental disorder or not, it’s not normal to kill 150 people. If the pilot did have a history of depression and was being treated at the time of this week’s flight, then we may be left with a very unsatisfactory answer.

The anti-psychiatry activists will say that psychotropic medications caused Lubitz to crash the plane. Psychiatrists will be left with no great answer with such a scenario and will be left to say that whatever treatment he was receiving, it wasn’t enough. Certainly, the physician who told Lubitz to take off from work was right: He didn’t belong in a cockpit that day. Presumably, that physician would have done more had he been aware that the patient was about to commit a mass murder.

If the copilot does have a history of depression, but his current work excuse was for an unrelated condition, we might wonder if an untreated recurrence of depression played some role in his actions. One might speculate that the copilot could have been afraid to seek care at this time, perhaps because of a fear that he would lose his vocation.

Still, major depression can hardly explain such an act, and it is unfortunate that the press has already begun to run headlines linking this man’s alleged psychiatric diagnosis to a catastrophic mass murder. Somehow, “mental illness” gets used as an endpoint explanation for why such things happen; and short of a severe psychotic delusional system, it’s a very unsatisfying answer for an unprecedented act of violence.

The facts will unfold and perhaps we’ll learn a little more. We’ll find out what condition the copilot was being treated for and whether there were other stresses going on in his personal life. But people get depressed, take antidepressants, and deal with stress all the time.

It’s possible, if not likely, that we’ll never understand why this copilot decided to end the lives of so many people along with his own.

Dr. Miller is a coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work (Baltimore: The Johns Hopkins University, 2011).

Earlier this week, an airplane headed from Barcelona to Dusseldorf crashed into the French Alps, leaving 150 people dead. The black box recorder indicated that the copilot was left alone in the cockpit, the pilot was locked out and attempted to gain re-entry, and the flight was reprogrammed to cruise at an altitude of 100 feet, causing the plane to crash after an 8-minute descent. The evidence indicates a deliberate action on the part of the 27-year-old co-pilot, Andreas Lubitz.

With nothing to point to terrorism at this point, the investigation will include the question of whether or not the copilot suffered from a mental illness as a way of explaining his unexplainable actions. In short, was this a combination mass murder/suicide? Was there any way to predict that such an atrocity might happen? Are there measures that can be taken to ensure that it doesn’t happen again?

In the United States, treatment with any psychotropic medication has been a reason to ground a pilot permanently. In April 2010, the Federal Aviation Administration’s rules changed such that a pilot could fly if he’d been treated for mild to moderate depression with a selective serotonin reuptake inhibitor after 12 months. At that time, the FAA announced a 6-month amnesty period where a pilot could come forward about a diagnosis of depression that he had not previously felt comfortable disclosing. Presumably, other countries also have rules that ground pilots for mental illness.

So far, some reports in the media indicate that the copilot was not obviously suffering from a psychiatric disorder; all those who have been interviewed for these reports have expressed shock that Lubitz might have deliberately crashed the plane.

There also has been speculation in the media that a break in the copilot’s training 6 years ago was due to depression, and the mother of a school mate reportedly said that Lubitz had been treated for depression. Finally, investigators found a doctor’s note excusing Lubitz from work. At this point, the Wall Street Journal is reporting that he was being treated for depression. Apparently, he had shredded the note and flew on Tuesday, despite the written work excuse.

Still, all discussion of the copilot’s mental state is purely speculation. The media is noted for sensationalist reporting – and in efforts to get information out quickly, the details are often confused or simply wrong, sometimes to a remarkable extent. We don’t know if the work excuse was written by a psychiatrist or another type of physician; we don’t know if it was for a psychiatric condition, cancer, or simply strep throat.

What we’ve been told is that a copilot who was cleared to fly did so despite a work excuse from a physician, he did not disclose this condition to his employer, and he crashed a plane killing 150 people.

We might assume that the pilot suffered from some type of psychic distress – whether he met criteria for a mental disorder or not, it’s not normal to kill 150 people. If the pilot did have a history of depression and was being treated at the time of this week’s flight, then we may be left with a very unsatisfactory answer.

The anti-psychiatry activists will say that psychotropic medications caused Lubitz to crash the plane. Psychiatrists will be left with no great answer with such a scenario and will be left to say that whatever treatment he was receiving, it wasn’t enough. Certainly, the physician who told Lubitz to take off from work was right: He didn’t belong in a cockpit that day. Presumably, that physician would have done more had he been aware that the patient was about to commit a mass murder.

If the copilot does have a history of depression, but his current work excuse was for an unrelated condition, we might wonder if an untreated recurrence of depression played some role in his actions. One might speculate that the copilot could have been afraid to seek care at this time, perhaps because of a fear that he would lose his vocation.

Still, major depression can hardly explain such an act, and it is unfortunate that the press has already begun to run headlines linking this man’s alleged psychiatric diagnosis to a catastrophic mass murder. Somehow, “mental illness” gets used as an endpoint explanation for why such things happen; and short of a severe psychotic delusional system, it’s a very unsatisfying answer for an unprecedented act of violence.

The facts will unfold and perhaps we’ll learn a little more. We’ll find out what condition the copilot was being treated for and whether there were other stresses going on in his personal life. But people get depressed, take antidepressants, and deal with stress all the time.

It’s possible, if not likely, that we’ll never understand why this copilot decided to end the lives of so many people along with his own.

Dr. Miller is a coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work (Baltimore: The Johns Hopkins University, 2011).

Red blood cells

Image courtesy of NHLBI

The US Food and Drug Administration (FDA) has granted orphan drug designation to AG-348 for the treatment of pyruvate kinase deficiency (PKD), a rare form of hemolytic anemia.

AG-348 is a small molecule allosteric activator of pyruvate kinase-R enzymes that directly targets the underlying metabolic defect in PKD.

The orphan designation will provide Agios Pharmaceuticals, the company developing AG-348, with certain benefits. These include market exclusivity upon regulatory approval and exemption from FDA application fees and tax credits for qualified clinical trials.

According to Agios, AG-348 exhibited favorable safety and pharmacokinetic profiles in a pair of phase 1 studies conducted in healthy volunteers.

Study investigators also observed dose-dependent changes in adenosine triphosphate (ATP) and 2,3-DPG blood levels, which are consistent with increased activity of the glycolytic pathway, the expected pharmacodynamic effect of AG-348.

Results from both studies were presented in a poster at the 2014 ASH Annual Meeting (abstract 4007*). One of the studies was a single ascending dose (SAD) study, and the other was a multiple ascending dose (MAD) study.

SAD study

In this study, healthy volunteers were randomized to receive AG-348 (n=36) or placebo (n=12). Patients were divided into 6 dosing cohorts: 30 mg, 120 mg, 360 mg, 700 mg, 1400 mg, and 2500 mg.

The maximum-tolerated dose of AG-348 was not reached, and there were no serious adverse events (AEs) or early withdrawals among AG-348-treated subjects. Overall, the rate of AEs was 33.3% in the placebo arm and 44.4% in the AG-348 arm.

The rate of AEs that were considered possibly treatment-related was 16.7% in the placebo arm and 30.6% in the AG-348 arm. The most common treatment-related AEs were headache (occurring in 16.7% and 11.1% of patients, respectively), nausea (0% and 13.9%, respectively), and vomiting (0% and 5.6%, respectively).

Exposure to AG-348, as measured by area under the concentration × time curve (AUC), increased in a dose-proportional manner after a single dose. And absorption was rapid (median T_max ranged from 0.77 to 4.07 hours), although T_max increased and there was a less-than-proportional increase in C_max at higher doses.

When AG-348 was administered from 30 mg to 360 mg, there was a dose-dependent decrease in blood 2,3-DPG levels over 24 hours—up to a 49% mean decrease. Increasing the dose beyond 360 mg did not result in additional decreases in 2,3-DPG levels. And levels returned to placebo levels after about 72 hours.

There were minimal increases in blood ATP levels after AG-348 treatment at any dose.

MAD study

At the time of the presentation, 2 cohorts of 8 subjects each (6 receiving AG-348 and 2 receiving placebo) had completed treatment in the MAD study. One cohort received drug or placebo at 120 mg BID, and the other received 360 mg BID.

The pharmacokinetic results for day 1 of this study were consistent with those of the SAD study. However, the C_max and AUC_0-Ʈ were lower on day 14 than day 1. Investigators said this suggests that multiple doses of AG-348 increase the rate of its own metabolism.

They also said the decrease in exposure observed on day 14 is consistent with preclinical data that suggest AG-348 is a moderate inducer of CYP3A4, which is the major route of the oxidative metabolism of AG-348.

As in the SAD study, the investigators observed decreases in 2,3-DPG blood levels after the first dose in cohorts 1 and 2—up to a 48% mean decrease from baseline for both doses. Concentrations returned to placebo levels between 48 and 72 hours after the last dose.

Unlike in the SAD study, patients in this study had increases in ATP—up to a 52% mean increase from baseline in both dosing cohorts. ATP levels remained elevated through 72 hours after the last dose.

The investigators said the results of these 2 studies have informed dose selection for the planned phase 2 study of AG-348 in PKD patients, which is expected to begin soon.

*Information in the abstract differs from that presented at the meeting.

Red blood cells

Image courtesy of NHLBI

The US Food and Drug Administration (FDA) has granted orphan drug designation to AG-348 for the treatment of pyruvate kinase deficiency (PKD), a rare form of hemolytic anemia.

AG-348 is a small molecule allosteric activator of pyruvate kinase-R enzymes that directly targets the underlying metabolic defect in PKD.

The orphan designation will provide Agios Pharmaceuticals, the company developing AG-348, with certain benefits. These include market exclusivity upon regulatory approval and exemption from FDA application fees and tax credits for qualified clinical trials.

According to Agios, AG-348 exhibited favorable safety and pharmacokinetic profiles in a pair of phase 1 studies conducted in healthy volunteers.

Study investigators also observed dose-dependent changes in adenosine triphosphate (ATP) and 2,3-DPG blood levels, which are consistent with increased activity of the glycolytic pathway, the expected pharmacodynamic effect of AG-348.

Results from both studies were presented in a poster at the 2014 ASH Annual Meeting (abstract 4007*). One of the studies was a single ascending dose (SAD) study, and the other was a multiple ascending dose (MAD) study.

SAD study

In this study, healthy volunteers were randomized to receive AG-348 (n=36) or placebo (n=12). Patients were divided into 6 dosing cohorts: 30 mg, 120 mg, 360 mg, 700 mg, 1400 mg, and 2500 mg.

The maximum-tolerated dose of AG-348 was not reached, and there were no serious adverse events (AEs) or early withdrawals among AG-348-treated subjects. Overall, the rate of AEs was 33.3% in the placebo arm and 44.4% in the AG-348 arm.

The rate of AEs that were considered possibly treatment-related was 16.7% in the placebo arm and 30.6% in the AG-348 arm. The most common treatment-related AEs were headache (occurring in 16.7% and 11.1% of patients, respectively), nausea (0% and 13.9%, respectively), and vomiting (0% and 5.6%, respectively).

Exposure to AG-348, as measured by area under the concentration × time curve (AUC), increased in a dose-proportional manner after a single dose. And absorption was rapid (median T_max ranged from 0.77 to 4.07 hours), although T_max increased and there was a less-than-proportional increase in C_max at higher doses.

When AG-348 was administered from 30 mg to 360 mg, there was a dose-dependent decrease in blood 2,3-DPG levels over 24 hours—up to a 49% mean decrease. Increasing the dose beyond 360 mg did not result in additional decreases in 2,3-DPG levels. And levels returned to placebo levels after about 72 hours.

There were minimal increases in blood ATP levels after AG-348 treatment at any dose.

MAD study

At the time of the presentation, 2 cohorts of 8 subjects each (6 receiving AG-348 and 2 receiving placebo) had completed treatment in the MAD study. One cohort received drug or placebo at 120 mg BID, and the other received 360 mg BID.

The pharmacokinetic results for day 1 of this study were consistent with those of the SAD study. However, the C_max and AUC_0-Ʈ were lower on day 14 than day 1. Investigators said this suggests that multiple doses of AG-348 increase the rate of its own metabolism.

They also said the decrease in exposure observed on day 14 is consistent with preclinical data that suggest AG-348 is a moderate inducer of CYP3A4, which is the major route of the oxidative metabolism of AG-348.

As in the SAD study, the investigators observed decreases in 2,3-DPG blood levels after the first dose in cohorts 1 and 2—up to a 48% mean decrease from baseline for both doses. Concentrations returned to placebo levels between 48 and 72 hours after the last dose.

Unlike in the SAD study, patients in this study had increases in ATP—up to a 52% mean increase from baseline in both dosing cohorts. ATP levels remained elevated through 72 hours after the last dose.

The investigators said the results of these 2 studies have informed dose selection for the planned phase 2 study of AG-348 in PKD patients, which is expected to begin soon.

*Information in the abstract differs from that presented at the meeting.

Red blood cells

Image courtesy of NHLBI

The US Food and Drug Administration (FDA) has granted orphan drug designation to AG-348 for the treatment of pyruvate kinase deficiency (PKD), a rare form of hemolytic anemia.

AG-348 is a small molecule allosteric activator of pyruvate kinase-R enzymes that directly targets the underlying metabolic defect in PKD.

The orphan designation will provide Agios Pharmaceuticals, the company developing AG-348, with certain benefits. These include market exclusivity upon regulatory approval and exemption from FDA application fees and tax credits for qualified clinical trials.

According to Agios, AG-348 exhibited favorable safety and pharmacokinetic profiles in a pair of phase 1 studies conducted in healthy volunteers.

Study investigators also observed dose-dependent changes in adenosine triphosphate (ATP) and 2,3-DPG blood levels, which are consistent with increased activity of the glycolytic pathway, the expected pharmacodynamic effect of AG-348.

Results from both studies were presented in a poster at the 2014 ASH Annual Meeting (abstract 4007*). One of the studies was a single ascending dose (SAD) study, and the other was a multiple ascending dose (MAD) study.

SAD study

In this study, healthy volunteers were randomized to receive AG-348 (n=36) or placebo (n=12). Patients were divided into 6 dosing cohorts: 30 mg, 120 mg, 360 mg, 700 mg, 1400 mg, and 2500 mg.

The maximum-tolerated dose of AG-348 was not reached, and there were no serious adverse events (AEs) or early withdrawals among AG-348-treated subjects. Overall, the rate of AEs was 33.3% in the placebo arm and 44.4% in the AG-348 arm.

The rate of AEs that were considered possibly treatment-related was 16.7% in the placebo arm and 30.6% in the AG-348 arm. The most common treatment-related AEs were headache (occurring in 16.7% and 11.1% of patients, respectively), nausea (0% and 13.9%, respectively), and vomiting (0% and 5.6%, respectively).

Exposure to AG-348, as measured by area under the concentration × time curve (AUC), increased in a dose-proportional manner after a single dose. And absorption was rapid (median T_max ranged from 0.77 to 4.07 hours), although T_max increased and there was a less-than-proportional increase in C_max at higher doses.

When AG-348 was administered from 30 mg to 360 mg, there was a dose-dependent decrease in blood 2,3-DPG levels over 24 hours—up to a 49% mean decrease. Increasing the dose beyond 360 mg did not result in additional decreases in 2,3-DPG levels. And levels returned to placebo levels after about 72 hours.

There were minimal increases in blood ATP levels after AG-348 treatment at any dose.

MAD study

At the time of the presentation, 2 cohorts of 8 subjects each (6 receiving AG-348 and 2 receiving placebo) had completed treatment in the MAD study. One cohort received drug or placebo at 120 mg BID, and the other received 360 mg BID.

The pharmacokinetic results for day 1 of this study were consistent with those of the SAD study. However, the C_max and AUC_0-Ʈ were lower on day 14 than day 1. Investigators said this suggests that multiple doses of AG-348 increase the rate of its own metabolism.

They also said the decrease in exposure observed on day 14 is consistent with preclinical data that suggest AG-348 is a moderate inducer of CYP3A4, which is the major route of the oxidative metabolism of AG-348.

As in the SAD study, the investigators observed decreases in 2,3-DPG blood levels after the first dose in cohorts 1 and 2—up to a 48% mean decrease from baseline for both doses. Concentrations returned to placebo levels between 48 and 72 hours after the last dose.

Unlike in the SAD study, patients in this study had increases in ATP—up to a 52% mean increase from baseline in both dosing cohorts. ATP levels remained elevated through 72 hours after the last dose.

The investigators said the results of these 2 studies have informed dose selection for the planned phase 2 study of AG-348 in PKD patients, which is expected to begin soon.

*Information in the abstract differs from that presented at the meeting.

Olympus, the manufacturer of the TJF-Q180V duodenoscope, has issued new, validated instructions for reprocessing this particular model, as part of the response to recent reports of a possible association between multidrug-resistant bacterial infections and improperly processed duodenoscopes, according to the Food and Drug Administration.

The new instructions, which replace the manual reprocessing instructions included in the original labeling, and validation data have been reviewed by the FDA as part of its ongoing review of the device. The agency “recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible,” according to an FDA statement. The instructions are provided in letters sent by Olympus to health care and other facilities that use this particular model.

“Key changes” have been made to the procedures for precleaning, manual cleaning, and manual high-level disinfection reprocessing procedures, the FDA said.

The TJF-Q180 V duodenoscope was the model used in four patients who had undergone an endoscopic retrograde cholangiopancreatography (ERCP) procedure between August 2014 and January 2015 with the same duodenoscope at Cedars-Sinai Medical Center in Los Angeles and had been infected with carbapenem-resistant Enterobacteriaceae (CRE). This outbreak was announced by the medical center in early March in a statement that said the infections occurred “despite the fact that Cedars-Sinai meticulously followed the disinfection procedure for duodenoscopes” recommended in instructions provided by Olympus and the FDA.

In February, the FDA first announced that the agency had received reports of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures with duodenoscopes, despite proper cleaning and disinfection of the devices and that the “complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.”

In the latest statement, the FDA said it “is closely monitoring the possible association between reprocessed duodenoscopes and the transmission of infectious agents,” including multidrug-resistant bacterial infections caused by CRE. If they are not properly reprocessed, the statement adds, “residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high-level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”

Adverse events associated with duodenoscopes should be reported to the FDA’s MedWatch Program at 800-332-1088 or www.accessdata.fda.gov/scripts/medwatch.

AGA Resource
Read more about AGA’s efforts and recommendations to stop duodenoscope infections here.

[email protected]

Olympus, the manufacturer of the TJF-Q180V duodenoscope, has issued new, validated instructions for reprocessing this particular model, as part of the response to recent reports of a possible association between multidrug-resistant bacterial infections and improperly processed duodenoscopes, according to the Food and Drug Administration.

The new instructions, which replace the manual reprocessing instructions included in the original labeling, and validation data have been reviewed by the FDA as part of its ongoing review of the device. The agency “recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible,” according to an FDA statement. The instructions are provided in letters sent by Olympus to health care and other facilities that use this particular model.

“Key changes” have been made to the procedures for precleaning, manual cleaning, and manual high-level disinfection reprocessing procedures, the FDA said.

The TJF-Q180 V duodenoscope was the model used in four patients who had undergone an endoscopic retrograde cholangiopancreatography (ERCP) procedure between August 2014 and January 2015 with the same duodenoscope at Cedars-Sinai Medical Center in Los Angeles and had been infected with carbapenem-resistant Enterobacteriaceae (CRE). This outbreak was announced by the medical center in early March in a statement that said the infections occurred “despite the fact that Cedars-Sinai meticulously followed the disinfection procedure for duodenoscopes” recommended in instructions provided by Olympus and the FDA.

In February, the FDA first announced that the agency had received reports of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures with duodenoscopes, despite proper cleaning and disinfection of the devices and that the “complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.”

In the latest statement, the FDA said it “is closely monitoring the possible association between reprocessed duodenoscopes and the transmission of infectious agents,” including multidrug-resistant bacterial infections caused by CRE. If they are not properly reprocessed, the statement adds, “residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high-level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”

Adverse events associated with duodenoscopes should be reported to the FDA’s MedWatch Program at 800-332-1088 or www.accessdata.fda.gov/scripts/medwatch.

AGA Resource
Read more about AGA’s efforts and recommendations to stop duodenoscope infections here.

[email protected]

Olympus, the manufacturer of the TJF-Q180V duodenoscope, has issued new, validated instructions for reprocessing this particular model, as part of the response to recent reports of a possible association between multidrug-resistant bacterial infections and improperly processed duodenoscopes, according to the Food and Drug Administration.

The new instructions, which replace the manual reprocessing instructions included in the original labeling, and validation data have been reviewed by the FDA as part of its ongoing review of the device. The agency “recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible,” according to an FDA statement. The instructions are provided in letters sent by Olympus to health care and other facilities that use this particular model.

“Key changes” have been made to the procedures for precleaning, manual cleaning, and manual high-level disinfection reprocessing procedures, the FDA said.

The TJF-Q180 V duodenoscope was the model used in four patients who had undergone an endoscopic retrograde cholangiopancreatography (ERCP) procedure between August 2014 and January 2015 with the same duodenoscope at Cedars-Sinai Medical Center in Los Angeles and had been infected with carbapenem-resistant Enterobacteriaceae (CRE). This outbreak was announced by the medical center in early March in a statement that said the infections occurred “despite the fact that Cedars-Sinai meticulously followed the disinfection procedure for duodenoscopes” recommended in instructions provided by Olympus and the FDA.

In February, the FDA first announced that the agency had received reports of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures with duodenoscopes, despite proper cleaning and disinfection of the devices and that the “complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.”

In the latest statement, the FDA said it “is closely monitoring the possible association between reprocessed duodenoscopes and the transmission of infectious agents,” including multidrug-resistant bacterial infections caused by CRE. If they are not properly reprocessed, the statement adds, “residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high-level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”

Adverse events associated with duodenoscopes should be reported to the FDA’s MedWatch Program at 800-332-1088 or www.accessdata.fda.gov/scripts/medwatch.

AGA Resource
Read more about AGA’s efforts and recommendations to stop duodenoscope infections here.

[email protected]

Hip replacement is becoming more common among middle-aged Americans at the same time as the number of surgeons who perform the procedure is declining, Dr. Alexander S. McLawhorn said at the annual meeting of the American Academy of Orthopaedic Surgeons in Las Vegas.

In 2011, patients aged 45-64 years underwent 42.3% of the hip replacements performed, compared with 33.9% in 2002. The number of replacements performed rose from approximately 68,000 in 2002 to 128,000 in 2011, an increase of 89.2%, compared with an increase of 37.0% among those aged 65 years and older, according to data from the Nationwide Inpatient Sample.

This “observed growth was best explained by an expansion of the middle-aged population in the United States. This particular age group is projected to continue expanding, and as such the demand for [hip replacement] in this active group of patients will likely continue to rise as well,” Dr. McLawhorn of the Hospital for Special Surgery, New York, said in a written statement.

According to membership data from the AAOS, however, the number of physicians performing hip replacements declined by almost 29% from 2002 to 2011, which will “increase the future revision burden” on those surgeons who are still doing the procedure, the investigators said.

Dr. McLawhorn had no conflicts to report, but one of his associates disclosed relationships with Ethicon, the Knee Society, Medtronic, Mekanika, and Zimmer.

[email protected]

Hip replacement is becoming more common among middle-aged Americans at the same time as the number of surgeons who perform the procedure is declining, Dr. Alexander S. McLawhorn said at the annual meeting of the American Academy of Orthopaedic Surgeons in Las Vegas.

In 2011, patients aged 45-64 years underwent 42.3% of the hip replacements performed, compared with 33.9% in 2002. The number of replacements performed rose from approximately 68,000 in 2002 to 128,000 in 2011, an increase of 89.2%, compared with an increase of 37.0% among those aged 65 years and older, according to data from the Nationwide Inpatient Sample.

This “observed growth was best explained by an expansion of the middle-aged population in the United States. This particular age group is projected to continue expanding, and as such the demand for [hip replacement] in this active group of patients will likely continue to rise as well,” Dr. McLawhorn of the Hospital for Special Surgery, New York, said in a written statement.

According to membership data from the AAOS, however, the number of physicians performing hip replacements declined by almost 29% from 2002 to 2011, which will “increase the future revision burden” on those surgeons who are still doing the procedure, the investigators said.

Dr. McLawhorn had no conflicts to report, but one of his associates disclosed relationships with Ethicon, the Knee Society, Medtronic, Mekanika, and Zimmer.

[email protected]

Hip replacement is becoming more common among middle-aged Americans at the same time as the number of surgeons who perform the procedure is declining, Dr. Alexander S. McLawhorn said at the annual meeting of the American Academy of Orthopaedic Surgeons in Las Vegas.

In 2011, patients aged 45-64 years underwent 42.3% of the hip replacements performed, compared with 33.9% in 2002. The number of replacements performed rose from approximately 68,000 in 2002 to 128,000 in 2011, an increase of 89.2%, compared with an increase of 37.0% among those aged 65 years and older, according to data from the Nationwide Inpatient Sample.

This “observed growth was best explained by an expansion of the middle-aged population in the United States. This particular age group is projected to continue expanding, and as such the demand for [hip replacement] in this active group of patients will likely continue to rise as well,” Dr. McLawhorn of the Hospital for Special Surgery, New York, said in a written statement.

According to membership data from the AAOS, however, the number of physicians performing hip replacements declined by almost 29% from 2002 to 2011, which will “increase the future revision burden” on those surgeons who are still doing the procedure, the investigators said.

Dr. McLawhorn had no conflicts to report, but one of his associates disclosed relationships with Ethicon, the Knee Society, Medtronic, Mekanika, and Zimmer.

[email protected]

LAS VEGAS—While women may have their first total joint replacement (TJR) at an older age, they are less likely to have complications related to their surgery or require revision surgery, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). The findings contradict the theory that TJR is underutilized in female patients because they have worse outcomes than men.

Researchers reviewed patient databases from an Ontario hospital for first-time primary total hip replacement (THR) and total knee replacement (TKR) patients between 2002 and 2009. There were 37,881 THR surgeries (53.8% female) and 59,564 TKR surgeries (60.5% female). Women who underwent THR were significantly older than males (70 years vs. 65 years); however, there was no difference in age between male and female patients undergoing TKR (median age 68 years for both). A greater proportion of female patients undergoing TJR were defined as frail (6.6% vs. 3.5% for THR; and, 6.7% vs. 4% for TKR).

Following surgery, men were:

• 15% more likely to return to the emergency department within 30 days of hospital discharge following either THR or TKR.

• 60% and 70% more likely to have an acute myocardial infarction within 3 months following THR and TKR, respectively.

• 50% more likely to require a revision arthroplasty within 2 years of TKR.

• 25% more likely to be readmitted to the hospital and 70% more likely to experience an infection or revision surgery within 2 years of TKR, compared to women.

“Despite the fact that women have a higher prevalence of advanced hip and knee arthritis, prior research indicates that North American women with arthritis are less likely to receive joint replacement than men,” said lead study author Bheeshma Ravi, MD, PhD, an orthopedic surgery resident at the University of Toronto. “One possible explanation is that women are less often offered or accept surgery because their risk of serious complications following surgery is greater than that of men.

“In this study, we found that while overall rates of serious complications were low for both groups, they were lower for women than for men for both hip and knee replacement, particularly the latter” said Dr. Ravi. “Thus, the previously documented sex difference utilization of TJR cannot be explained by differential risks of complications following surgery.”

LAS VEGAS—While women may have their first total joint replacement (TJR) at an older age, they are less likely to have complications related to their surgery or require revision surgery, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). The findings contradict the theory that TJR is underutilized in female patients because they have worse outcomes than men.

Researchers reviewed patient databases from an Ontario hospital for first-time primary total hip replacement (THR) and total knee replacement (TKR) patients between 2002 and 2009. There were 37,881 THR surgeries (53.8% female) and 59,564 TKR surgeries (60.5% female). Women who underwent THR were significantly older than males (70 years vs. 65 years); however, there was no difference in age between male and female patients undergoing TKR (median age 68 years for both). A greater proportion of female patients undergoing TJR were defined as frail (6.6% vs. 3.5% for THR; and, 6.7% vs. 4% for TKR).

Following surgery, men were:

• 15% more likely to return to the emergency department within 30 days of hospital discharge following either THR or TKR.

• 60% and 70% more likely to have an acute myocardial infarction within 3 months following THR and TKR, respectively.

• 50% more likely to require a revision arthroplasty within 2 years of TKR.

• 25% more likely to be readmitted to the hospital and 70% more likely to experience an infection or revision surgery within 2 years of TKR, compared to women.

“Despite the fact that women have a higher prevalence of advanced hip and knee arthritis, prior research indicates that North American women with arthritis are less likely to receive joint replacement than men,” said lead study author Bheeshma Ravi, MD, PhD, an orthopedic surgery resident at the University of Toronto. “One possible explanation is that women are less often offered or accept surgery because their risk of serious complications following surgery is greater than that of men.

“In this study, we found that while overall rates of serious complications were low for both groups, they were lower for women than for men for both hip and knee replacement, particularly the latter” said Dr. Ravi. “Thus, the previously documented sex difference utilization of TJR cannot be explained by differential risks of complications following surgery.”

LAS VEGAS—While women may have their first total joint replacement (TJR) at an older age, they are less likely to have complications related to their surgery or require revision surgery, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). The findings contradict the theory that TJR is underutilized in female patients because they have worse outcomes than men.

Researchers reviewed patient databases from an Ontario hospital for first-time primary total hip replacement (THR) and total knee replacement (TKR) patients between 2002 and 2009. There were 37,881 THR surgeries (53.8% female) and 59,564 TKR surgeries (60.5% female). Women who underwent THR were significantly older than males (70 years vs. 65 years); however, there was no difference in age between male and female patients undergoing TKR (median age 68 years for both). A greater proportion of female patients undergoing TJR were defined as frail (6.6% vs. 3.5% for THR; and, 6.7% vs. 4% for TKR).

Following surgery, men were:

• 15% more likely to return to the emergency department within 30 days of hospital discharge following either THR or TKR.

• 60% and 70% more likely to have an acute myocardial infarction within 3 months following THR and TKR, respectively.

• 50% more likely to require a revision arthroplasty within 2 years of TKR.

• 25% more likely to be readmitted to the hospital and 70% more likely to experience an infection or revision surgery within 2 years of TKR, compared to women.

“Despite the fact that women have a higher prevalence of advanced hip and knee arthritis, prior research indicates that North American women with arthritis are less likely to receive joint replacement than men,” said lead study author Bheeshma Ravi, MD, PhD, an orthopedic surgery resident at the University of Toronto. “One possible explanation is that women are less often offered or accept surgery because their risk of serious complications following surgery is greater than that of men.

“In this study, we found that while overall rates of serious complications were low for both groups, they were lower for women than for men for both hip and knee replacement, particularly the latter” said Dr. Ravi. “Thus, the previously documented sex difference utilization of TJR cannot be explained by differential risks of complications following surgery.”

LAS VEGAS—Black and Hispanic patients were 62% and 50%, respectively, more likely to be readmitted to the hospital within 30 days after total joint replacement (TJR) surgery compared to white patients, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). In addition, Medicaid patients were 40% more likely to be readmitted to the hospital than patients with private insurance. Poorer outcomes, due in part to patient comorbidities, may reflect limited access to primary care, insufficient patient-doctor communication, researchers suggest.

Disparities in the provision of health care services have long been documented, including that black patients utilize hip and total knee replacement at rates nearly 40% less than white patients, despite having comparable or higher rates of osteoarthritis.

In this study, researchers analyzed 5 years of data—demographic (including race/ethnicity), clinical, and billing—on nearly 53,000 patients admitted to Connecticut hospitals for TJR from 2008 to 2012. The average patient age was 67 years, and the vast majority of patients were white (87%), covered by Medicare (56.7%), and female (61%).

The overall 30-day readmission rate for patients was 5.2%. The most common reasons for readmission were postoperative infection (8%), infection and inflammatory reaction due to internal joint prosthesis (6%), hematoma complications during a procedure (3%), and dislocation of a prosthetic joint (3%). Among the other study findings:

• Readmission rates were 83.5 per thousand for black patients, 78.9 for Hispanic patients, and 53.3 for white patients.

• Longer length of hospital stay was significantly associated with increased odds of readmission.

• When controlling for comorbidities and type of insurance coverage, the readmission rate for Hispanic patients dropped 44%, and for black patients, 38%. Black patients remained significantly more likely than white patients to be readmitted following surgery, after controlling for comorbidities.

• Patients covered by Medicare were 30% more likely to be readmitted within 30 days following discharge compared to patients covered by private insurance, and Medicaid patients were 40% more likely.

Recent research using national data on Medicare suggests that community-based factors, such as availability of general practitioners in the area, may be as or more important than hospital factors in determining readmission rates, and that patients may have few options other than hospital care for both urgent and non-urgent conditions related to their surgery or other conditions.

“Using an all-payer database, our study shows that black patients who undergo total knee replacement may have poorer outcomes,” said lead study author and orthopedic surgeon Courtland Lewis, MD. “After controlling for two key variables implicated in race and ethnic disparities in hospital readmission—preoperative comorbidities and type of insurance coverage—black patients still have a 35% higher likelihood of all-cause, 30-day readmission compared to white patients.

“Our ongoing research in this area is focused on other factors, such as the patient’s connection to primary care and patient-provider communication, that may explain this troubling finding,” said Dr. Lewis.

LAS VEGAS—Black and Hispanic patients were 62% and 50%, respectively, more likely to be readmitted to the hospital within 30 days after total joint replacement (TJR) surgery compared to white patients, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). In addition, Medicaid patients were 40% more likely to be readmitted to the hospital than patients with private insurance. Poorer outcomes, due in part to patient comorbidities, may reflect limited access to primary care, insufficient patient-doctor communication, researchers suggest.

Disparities in the provision of health care services have long been documented, including that black patients utilize hip and total knee replacement at rates nearly 40% less than white patients, despite having comparable or higher rates of osteoarthritis.

In this study, researchers analyzed 5 years of data—demographic (including race/ethnicity), clinical, and billing—on nearly 53,000 patients admitted to Connecticut hospitals for TJR from 2008 to 2012. The average patient age was 67 years, and the vast majority of patients were white (87%), covered by Medicare (56.7%), and female (61%).

The overall 30-day readmission rate for patients was 5.2%. The most common reasons for readmission were postoperative infection (8%), infection and inflammatory reaction due to internal joint prosthesis (6%), hematoma complications during a procedure (3%), and dislocation of a prosthetic joint (3%). Among the other study findings:

• Readmission rates were 83.5 per thousand for black patients, 78.9 for Hispanic patients, and 53.3 for white patients.

• Longer length of hospital stay was significantly associated with increased odds of readmission.

• When controlling for comorbidities and type of insurance coverage, the readmission rate for Hispanic patients dropped 44%, and for black patients, 38%. Black patients remained significantly more likely than white patients to be readmitted following surgery, after controlling for comorbidities.

• Patients covered by Medicare were 30% more likely to be readmitted within 30 days following discharge compared to patients covered by private insurance, and Medicaid patients were 40% more likely.

Recent research using national data on Medicare suggests that community-based factors, such as availability of general practitioners in the area, may be as or more important than hospital factors in determining readmission rates, and that patients may have few options other than hospital care for both urgent and non-urgent conditions related to their surgery or other conditions.

“Using an all-payer database, our study shows that black patients who undergo total knee replacement may have poorer outcomes,” said lead study author and orthopedic surgeon Courtland Lewis, MD. “After controlling for two key variables implicated in race and ethnic disparities in hospital readmission—preoperative comorbidities and type of insurance coverage—black patients still have a 35% higher likelihood of all-cause, 30-day readmission compared to white patients.

“Our ongoing research in this area is focused on other factors, such as the patient’s connection to primary care and patient-provider communication, that may explain this troubling finding,” said Dr. Lewis.

LAS VEGAS—Black and Hispanic patients were 62% and 50%, respectively, more likely to be readmitted to the hospital within 30 days after total joint replacement (TJR) surgery compared to white patients, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). In addition, Medicaid patients were 40% more likely to be readmitted to the hospital than patients with private insurance. Poorer outcomes, due in part to patient comorbidities, may reflect limited access to primary care, insufficient patient-doctor communication, researchers suggest.

Disparities in the provision of health care services have long been documented, including that black patients utilize hip and total knee replacement at rates nearly 40% less than white patients, despite having comparable or higher rates of osteoarthritis.

In this study, researchers analyzed 5 years of data—demographic (including race/ethnicity), clinical, and billing—on nearly 53,000 patients admitted to Connecticut hospitals for TJR from 2008 to 2012. The average patient age was 67 years, and the vast majority of patients were white (87%), covered by Medicare (56.7%), and female (61%).

The overall 30-day readmission rate for patients was 5.2%. The most common reasons for readmission were postoperative infection (8%), infection and inflammatory reaction due to internal joint prosthesis (6%), hematoma complications during a procedure (3%), and dislocation of a prosthetic joint (3%). Among the other study findings:

• Readmission rates were 83.5 per thousand for black patients, 78.9 for Hispanic patients, and 53.3 for white patients.

• Longer length of hospital stay was significantly associated with increased odds of readmission.

• When controlling for comorbidities and type of insurance coverage, the readmission rate for Hispanic patients dropped 44%, and for black patients, 38%. Black patients remained significantly more likely than white patients to be readmitted following surgery, after controlling for comorbidities.

• Patients covered by Medicare were 30% more likely to be readmitted within 30 days following discharge compared to patients covered by private insurance, and Medicaid patients were 40% more likely.

Recent research using national data on Medicare suggests that community-based factors, such as availability of general practitioners in the area, may be as or more important than hospital factors in determining readmission rates, and that patients may have few options other than hospital care for both urgent and non-urgent conditions related to their surgery or other conditions.

“Using an all-payer database, our study shows that black patients who undergo total knee replacement may have poorer outcomes,” said lead study author and orthopedic surgeon Courtland Lewis, MD. “After controlling for two key variables implicated in race and ethnic disparities in hospital readmission—preoperative comorbidities and type of insurance coverage—black patients still have a 35% higher likelihood of all-cause, 30-day readmission compared to white patients.

“Our ongoing research in this area is focused on other factors, such as the patient’s connection to primary care and patient-provider communication, that may explain this troubling finding,” said Dr. Lewis.

LAS VEGAS—The number of total hip replacements (THRs) nearly doubled among middle-age patients between 2002 and 2011, primarily due to the expansion of the middle-age population in the United States, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). Continued growth in utilization of hip replacement surgery in patients ages 45 to 64 years, an increase in revision surgeries for this population as they age, and a nearly 30% decline in the number of surgeons who perform THR could have significant implications for future health care costs, THR demand, and access, researchers said.

The researchers used the Nationwide Inpatient Sample (NIS) to identify primary THRs performed between 2002 and 2011 in patients ages 45 to 64 years, as well as related hospital charges. Population data and projections were obtained from the US Census Bureau and surgeon workforce estimates from the AAOS.

In 2011, 42.3% of THRs were performed in patients ages 45 to 64 years compared to 33.9% in 2002. Utilization of THR in this age group increased 89.2% from 2002 to 2011, from approximately 68,000 THRs in 2002 to 128,000 THRs in 2011. The overall population increased 21.3%. In addition, the authors found that:

• Growth of THR utilization in the 45- to 64-year-old age group grew 2.4 times faster than it did in the Medicare-aged population (age > 65 years).

• A rise in the prevalence of obesity, a known risk factor for hip osteoarthritis, among middle-age Americans was not significantly associated with increased THR utilization.

• Mean hospital charges in the THR 45- to 64-year-old age group declined 5.7% from 2002 to 2011, and declined 2.5% in the Medicare population (age > 65 years).

• Mean physician reimbursement per THR, in 2011 US dollars, declined 26.2% over the same period.

• Concurrently, the number of physicians reporting that they performed THR surgeries declined 28.2%.

“The purpose of this study was to identify potential drivers of THR utilization in the middle-age patient segment,” said lead study author Alexander S. McLawhorn, MD, MBA, an orthopedic surgery resident at the Hospital for Special Surgery in New York City. “Our multivariable statistical model suggested that the observed growth was best explained by an expansion of the middle-age population in the US. This particular age group is projected to continue expanding, and as such the demand for THR in this active group of patients will likely continue to rise as well. Our results underscore concerns about consumption of premium-priced implants in younger patients and the future revision burden this trend implies in the face of a dwindling number of physicians who specialize in hip arthroplasty surgery.”

LAS VEGAS—The number of total hip replacements (THRs) nearly doubled among middle-age patients between 2002 and 2011, primarily due to the expansion of the middle-age population in the United States, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). Continued growth in utilization of hip replacement surgery in patients ages 45 to 64 years, an increase in revision surgeries for this population as they age, and a nearly 30% decline in the number of surgeons who perform THR could have significant implications for future health care costs, THR demand, and access, researchers said.

The researchers used the Nationwide Inpatient Sample (NIS) to identify primary THRs performed between 2002 and 2011 in patients ages 45 to 64 years, as well as related hospital charges. Population data and projections were obtained from the US Census Bureau and surgeon workforce estimates from the AAOS.

In 2011, 42.3% of THRs were performed in patients ages 45 to 64 years compared to 33.9% in 2002. Utilization of THR in this age group increased 89.2% from 2002 to 2011, from approximately 68,000 THRs in 2002 to 128,000 THRs in 2011. The overall population increased 21.3%. In addition, the authors found that:

• Growth of THR utilization in the 45- to 64-year-old age group grew 2.4 times faster than it did in the Medicare-aged population (age > 65 years).

• A rise in the prevalence of obesity, a known risk factor for hip osteoarthritis, among middle-age Americans was not significantly associated with increased THR utilization.

• Mean hospital charges in the THR 45- to 64-year-old age group declined 5.7% from 2002 to 2011, and declined 2.5% in the Medicare population (age > 65 years).

• Mean physician reimbursement per THR, in 2011 US dollars, declined 26.2% over the same period.

• Concurrently, the number of physicians reporting that they performed THR surgeries declined 28.2%.

“The purpose of this study was to identify potential drivers of THR utilization in the middle-age patient segment,” said lead study author Alexander S. McLawhorn, MD, MBA, an orthopedic surgery resident at the Hospital for Special Surgery in New York City. “Our multivariable statistical model suggested that the observed growth was best explained by an expansion of the middle-age population in the US. This particular age group is projected to continue expanding, and as such the demand for THR in this active group of patients will likely continue to rise as well. Our results underscore concerns about consumption of premium-priced implants in younger patients and the future revision burden this trend implies in the face of a dwindling number of physicians who specialize in hip arthroplasty surgery.”

LAS VEGAS—The number of total hip replacements (THRs) nearly doubled among middle-age patients between 2002 and 2011, primarily due to the expansion of the middle-age population in the United States, according to a study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). Continued growth in utilization of hip replacement surgery in patients ages 45 to 64 years, an increase in revision surgeries for this population as they age, and a nearly 30% decline in the number of surgeons who perform THR could have significant implications for future health care costs, THR demand, and access, researchers said.

The researchers used the Nationwide Inpatient Sample (NIS) to identify primary THRs performed between 2002 and 2011 in patients ages 45 to 64 years, as well as related hospital charges. Population data and projections were obtained from the US Census Bureau and surgeon workforce estimates from the AAOS.

In 2011, 42.3% of THRs were performed in patients ages 45 to 64 years compared to 33.9% in 2002. Utilization of THR in this age group increased 89.2% from 2002 to 2011, from approximately 68,000 THRs in 2002 to 128,000 THRs in 2011. The overall population increased 21.3%. In addition, the authors found that:

• Growth of THR utilization in the 45- to 64-year-old age group grew 2.4 times faster than it did in the Medicare-aged population (age > 65 years).

• A rise in the prevalence of obesity, a known risk factor for hip osteoarthritis, among middle-age Americans was not significantly associated with increased THR utilization.

• Mean hospital charges in the THR 45- to 64-year-old age group declined 5.7% from 2002 to 2011, and declined 2.5% in the Medicare population (age > 65 years).

• Mean physician reimbursement per THR, in 2011 US dollars, declined 26.2% over the same period.

• Concurrently, the number of physicians reporting that they performed THR surgeries declined 28.2%.

“The purpose of this study was to identify potential drivers of THR utilization in the middle-age patient segment,” said lead study author Alexander S. McLawhorn, MD, MBA, an orthopedic surgery resident at the Hospital for Special Surgery in New York City. “Our multivariable statistical model suggested that the observed growth was best explained by an expansion of the middle-age population in the US. This particular age group is projected to continue expanding, and as such the demand for THR in this active group of patients will likely continue to rise as well. Our results underscore concerns about consumption of premium-priced implants in younger patients and the future revision burden this trend implies in the face of a dwindling number of physicians who specialize in hip arthroplasty surgery.”

Use of long-acting reversible contraception (LARC) has increased nearly 5-fold in the last decade, reported the Centers for Disease Control and Prevention (CDC) in a National Center for Health Statistics (NCHS) Data Brief on the trends in LARC use among US women aged 15 to 44.¹ 

Data from the National Survey of Family Growth indicate that LARCs, which include intrauterine devices (IUDs) and subdermal hormonal implants, are gaining popularity because of their high efficacy in preventing unintended pregnancies. LARCs have demonstrated greater efficacy in preventing unintended pregnancy among all women compared with other contraceptive methods, including the oral contraceptive pill and the transdermal patch.

Age-related trends
For women aged 15 to 44, LARC use doubled between 2002 (1.5%) and the period 2006–2010 (3.8%) and then nearly doubled again for 2011–2013 (7.2%). IUD use increased 83% from the 2006–2010 period (3.5%) to the 2011–2013 period (6.4%). Implant use tripled from 2002 (0.3%) to the 2011–2013 period (0.8%).

LARC use was higher among women aged 25 to 34 than among women aged 15 to 24. The difference in LARC use was not statistically significant between women aged 25 to 34 and women aged 35 to 44.

•  LARC use increased nearly 4-fold for women aged 15 to 24 between 2002 (0.6%) and 2006–2010 (2.3%), and doubled again for 2011–2013 (5.0%).
• LARC use almost doubled among women aged 25 to 34 from 2006–2010 to 2011–2013 (5.3% to 11.1%).
• LARC use tripled between 2002 (1.1%) and 2006–2010 (3.8%) for women aged 35 to 44, and increased to 5.3% in 2011–2013.

Patterns of use by race
Although LARC use tripled for non-Hispanic white women and increased 4-fold for non-Hispanic black women between 2002 and 2006–2010, use among Hispanic women declined 10% during this period. LARC use increased by 129% among Hispanic women and by 128% among non-Hispanic white women from 2006–2010 to 2011–2013. Use of LARCs in non-Hispanic black women increased by 30% during this same period.

Parous vs nulliparous women
Women who have had at least one birth use LARC at a higher rate than women who have had no previous births. During the period 2011–2013, rate of use was 3 times greater among parous (11.0%) women compared with nulliparous (2.8%) women.

• Among parous women, LARC use increased from 2.4% in 2002 to 6.3% in 2006–2010, and to 10.6% in 2011–2013.
• In nulliparous women, LARC use increased 10-fold between 2006–2010 and 2011–2013.

For additional information, visit the NCHS Data Brief at http://www.cdc.gov/nchs/data/databriefs/db188.htm

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Use of long-acting reversible contraception (LARC) has increased nearly 5-fold in the last decade, reported the Centers for Disease Control and Prevention (CDC) in a National Center for Health Statistics (NCHS) Data Brief on the trends in LARC use among US women aged 15 to 44.¹ 

Data from the National Survey of Family Growth indicate that LARCs, which include intrauterine devices (IUDs) and subdermal hormonal implants, are gaining popularity because of their high efficacy in preventing unintended pregnancies. LARCs have demonstrated greater efficacy in preventing unintended pregnancy among all women compared with other contraceptive methods, including the oral contraceptive pill and the transdermal patch.

Age-related trends
For women aged 15 to 44, LARC use doubled between 2002 (1.5%) and the period 2006–2010 (3.8%) and then nearly doubled again for 2011–2013 (7.2%). IUD use increased 83% from the 2006–2010 period (3.5%) to the 2011–2013 period (6.4%). Implant use tripled from 2002 (0.3%) to the 2011–2013 period (0.8%).

LARC use was higher among women aged 25 to 34 than among women aged 15 to 24. The difference in LARC use was not statistically significant between women aged 25 to 34 and women aged 35 to 44.

•  LARC use increased nearly 4-fold for women aged 15 to 24 between 2002 (0.6%) and 2006–2010 (2.3%), and doubled again for 2011–2013 (5.0%).
• LARC use almost doubled among women aged 25 to 34 from 2006–2010 to 2011–2013 (5.3% to 11.1%).
• LARC use tripled between 2002 (1.1%) and 2006–2010 (3.8%) for women aged 35 to 44, and increased to 5.3% in 2011–2013.

Patterns of use by race
Although LARC use tripled for non-Hispanic white women and increased 4-fold for non-Hispanic black women between 2002 and 2006–2010, use among Hispanic women declined 10% during this period. LARC use increased by 129% among Hispanic women and by 128% among non-Hispanic white women from 2006–2010 to 2011–2013. Use of LARCs in non-Hispanic black women increased by 30% during this same period.

Parous vs nulliparous women
Women who have had at least one birth use LARC at a higher rate than women who have had no previous births. During the period 2011–2013, rate of use was 3 times greater among parous (11.0%) women compared with nulliparous (2.8%) women.

• Among parous women, LARC use increased from 2.4% in 2002 to 6.3% in 2006–2010, and to 10.6% in 2011–2013.
• In nulliparous women, LARC use increased 10-fold between 2006–2010 and 2011–2013.

For additional information, visit the NCHS Data Brief at http://www.cdc.gov/nchs/data/databriefs/db188.htm

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Use of long-acting reversible contraception (LARC) has increased nearly 5-fold in the last decade, reported the Centers for Disease Control and Prevention (CDC) in a National Center for Health Statistics (NCHS) Data Brief on the trends in LARC use among US women aged 15 to 44.¹ 

Data from the National Survey of Family Growth indicate that LARCs, which include intrauterine devices (IUDs) and subdermal hormonal implants, are gaining popularity because of their high efficacy in preventing unintended pregnancies. LARCs have demonstrated greater efficacy in preventing unintended pregnancy among all women compared with other contraceptive methods, including the oral contraceptive pill and the transdermal patch.

Age-related trends
For women aged 15 to 44, LARC use doubled between 2002 (1.5%) and the period 2006–2010 (3.8%) and then nearly doubled again for 2011–2013 (7.2%). IUD use increased 83% from the 2006–2010 period (3.5%) to the 2011–2013 period (6.4%). Implant use tripled from 2002 (0.3%) to the 2011–2013 period (0.8%).

LARC use was higher among women aged 25 to 34 than among women aged 15 to 24. The difference in LARC use was not statistically significant between women aged 25 to 34 and women aged 35 to 44.

•  LARC use increased nearly 4-fold for women aged 15 to 24 between 2002 (0.6%) and 2006–2010 (2.3%), and doubled again for 2011–2013 (5.0%).
• LARC use almost doubled among women aged 25 to 34 from 2006–2010 to 2011–2013 (5.3% to 11.1%).
• LARC use tripled between 2002 (1.1%) and 2006–2010 (3.8%) for women aged 35 to 44, and increased to 5.3% in 2011–2013.

Patterns of use by race
Although LARC use tripled for non-Hispanic white women and increased 4-fold for non-Hispanic black women between 2002 and 2006–2010, use among Hispanic women declined 10% during this period. LARC use increased by 129% among Hispanic women and by 128% among non-Hispanic white women from 2006–2010 to 2011–2013. Use of LARCs in non-Hispanic black women increased by 30% during this same period.

Parous vs nulliparous women
Women who have had at least one birth use LARC at a higher rate than women who have had no previous births. During the period 2011–2013, rate of use was 3 times greater among parous (11.0%) women compared with nulliparous (2.8%) women.

• Among parous women, LARC use increased from 2.4% in 2002 to 6.3% in 2006–2010, and to 10.6% in 2011–2013.
• In nulliparous women, LARC use increased 10-fold between 2006–2010 and 2011–2013.

For additional information, visit the NCHS Data Brief at http://www.cdc.gov/nchs/data/databriefs/db188.htm

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The National Heart, Lung, and Blood Institute offers an online resource you can use to reinforce what you’ve taught your patients about the need for adequate sleep. “Your Guide to Healthy Sleep” can be downloaded from http://www.nhlbi.nih.gov/files/docs/public/sleep/healthy_sleep.pdf. It describes the beneficial effects of sleep on an individual’s mood, memory, hormones, and heart; explains common sleep disorders and where to find treatment for them; and dispels the Top 10 Sleep Myths.

The National Heart, Lung, and Blood Institute offers an online resource you can use to reinforce what you’ve taught your patients about the need for adequate sleep. “Your Guide to Healthy Sleep” can be downloaded from http://www.nhlbi.nih.gov/files/docs/public/sleep/healthy_sleep.pdf. It describes the beneficial effects of sleep on an individual’s mood, memory, hormones, and heart; explains common sleep disorders and where to find treatment for them; and dispels the Top 10 Sleep Myths.

The National Heart, Lung, and Blood Institute offers an online resource you can use to reinforce what you’ve taught your patients about the need for adequate sleep. “Your Guide to Healthy Sleep” can be downloaded from http://www.nhlbi.nih.gov/files/docs/public/sleep/healthy_sleep.pdf. It describes the beneficial effects of sleep on an individual’s mood, memory, hormones, and heart; explains common sleep disorders and where to find treatment for them; and dispels the Top 10 Sleep Myths.

The Centers for Disease Control and Prevention has updated its online hepatitis C fact sheet. “Hepatitis C: General Information” is available at http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. It explains what hepatitis C is, how it’s spread, who should get tested, and how it can be prevented.

The Centers for Disease Control and Prevention has updated its online hepatitis C fact sheet. “Hepatitis C: General Information” is available at http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. It explains what hepatitis C is, how it’s spread, who should get tested, and how it can be prevented.

The Centers for Disease Control and Prevention has updated its online hepatitis C fact sheet. “Hepatitis C: General Information” is available at http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. It explains what hepatitis C is, how it’s spread, who should get tested, and how it can be prevented.