Photo by Daniel Gay

The US Food and Drug Administration (FDA) has released a revised guidance on testing donated blood and blood components for Zika virus.

The revised guidance states that it is no longer necessary to screen every donation individually.

Pooled donations can be tested for Zika virus in most cases, although, in areas where there is an increased risk of mosquito-borne transmission of Zika, donations should be tested individually.

The FDA said the revised guidance is a result of careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee.

“When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Now, given the significant decrease in cases of Zika virus infection in the US and its territories, we are moving away from testing each individual donation to testing pooled donations. This is usually more cost-effective and less burdensome for blood establishments. However, the FDA will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

The FDA’s revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing of individual units of blood donated in US states and territories.

The revised guidance explains that, to comply with applicable testing regulations, blood establishments must continue to test all donated whole blood and blood components for Zika virus using a nucleic acid test.

However, in many cases, pooled testing of donations using an FDA-licensed screening test is a sufficient method for complying with these regulations. If there is an increased risk of local mosquito-borne transmission of Zika virus in a specific area, donations should be tested individually.

As an alternative to pooled or individual testing, blood establishments can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.

The FDA said these recommendations will continue to ensure the safety of the US blood supply by reducing the risk of Zika virus transmission while also reducing the burden of testing for blood establishments.

Photo by Daniel Gay

The US Food and Drug Administration (FDA) has released a revised guidance on testing donated blood and blood components for Zika virus.

The revised guidance states that it is no longer necessary to screen every donation individually.

Pooled donations can be tested for Zika virus in most cases, although, in areas where there is an increased risk of mosquito-borne transmission of Zika, donations should be tested individually.

The FDA said the revised guidance is a result of careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee.

“When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Now, given the significant decrease in cases of Zika virus infection in the US and its territories, we are moving away from testing each individual donation to testing pooled donations. This is usually more cost-effective and less burdensome for blood establishments. However, the FDA will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

The FDA’s revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing of individual units of blood donated in US states and territories.

The revised guidance explains that, to comply with applicable testing regulations, blood establishments must continue to test all donated whole blood and blood components for Zika virus using a nucleic acid test.

However, in many cases, pooled testing of donations using an FDA-licensed screening test is a sufficient method for complying with these regulations. If there is an increased risk of local mosquito-borne transmission of Zika virus in a specific area, donations should be tested individually.

As an alternative to pooled or individual testing, blood establishments can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.

The FDA said these recommendations will continue to ensure the safety of the US blood supply by reducing the risk of Zika virus transmission while also reducing the burden of testing for blood establishments.

Photo by Daniel Gay

The US Food and Drug Administration (FDA) has released a revised guidance on testing donated blood and blood components for Zika virus.

The revised guidance states that it is no longer necessary to screen every donation individually.

Pooled donations can be tested for Zika virus in most cases, although, in areas where there is an increased risk of mosquito-borne transmission of Zika, donations should be tested individually.

The FDA said the revised guidance is a result of careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee.

“When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Now, given the significant decrease in cases of Zika virus infection in the US and its territories, we are moving away from testing each individual donation to testing pooled donations. This is usually more cost-effective and less burdensome for blood establishments. However, the FDA will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

The FDA’s revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing of individual units of blood donated in US states and territories.

The revised guidance explains that, to comply with applicable testing regulations, blood establishments must continue to test all donated whole blood and blood components for Zika virus using a nucleic acid test.

However, in many cases, pooled testing of donations using an FDA-licensed screening test is a sufficient method for complying with these regulations. If there is an increased risk of local mosquito-borne transmission of Zika virus in a specific area, donations should be tested individually.

As an alternative to pooled or individual testing, blood establishments can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.

The FDA said these recommendations will continue to ensure the safety of the US blood supply by reducing the risk of Zika virus transmission while also reducing the burden of testing for blood establishments.

The House GOP Doctors Caucus is pushing officials at the Centers for Medicare & Medicaid to lower the exclusion threshold for participation in the Merit-Based Incentive Payment System (MIPS).

In a letter to CMS Administrator Seema Verma, the lawmakers noted that about 60% of health care providers are excluded from MIPS – one track of the agency’s Quality Payment Program – mostly because of the high participation threshold set by the agency.

TheaDesign/Thinkstock

Since the program provides incentive payments to doctors by shifting Medicare Part B payments, the low participation is also lowering the payments available for high-level performance.

“The most notable ramification of the current threshold has been lower maximum positive updates on how MIPS ultimately adjusts Part B payments,” the lawmakers wrote. “For example, high performers are estimated to receive an aggregate payment adjustment in 2019 of 1.1% – based on their 2017 performance – even though adjustments of up to 4% are authorized.”

This payment trend “fails to incentivize meaningful participation in MIPS,” they wrote.

The current MIPS threshold excludes any physician or practice that generates $90,000 or less in Part B billing or sees 200 or fewer Medicare patients. The agency had initially set the threshold lower, at $30,000 or less in billing or 100 patients but created a larger exemption based on feedback from many physician groups.

The five members of the House GOP Doctors Caucus who signed on to the letter are Phil Roe (Tenn.), Andy Harris (Md.), Earl “Buddy” Carter (Ga.), Larry Bucshon (Ind.), and Scott DesJarlais (Tenn.).

[email protected]

The House GOP Doctors Caucus is pushing officials at the Centers for Medicare & Medicaid to lower the exclusion threshold for participation in the Merit-Based Incentive Payment System (MIPS).

In a letter to CMS Administrator Seema Verma, the lawmakers noted that about 60% of health care providers are excluded from MIPS – one track of the agency’s Quality Payment Program – mostly because of the high participation threshold set by the agency.

TheaDesign/Thinkstock

Since the program provides incentive payments to doctors by shifting Medicare Part B payments, the low participation is also lowering the payments available for high-level performance.

“The most notable ramification of the current threshold has been lower maximum positive updates on how MIPS ultimately adjusts Part B payments,” the lawmakers wrote. “For example, high performers are estimated to receive an aggregate payment adjustment in 2019 of 1.1% – based on their 2017 performance – even though adjustments of up to 4% are authorized.”

This payment trend “fails to incentivize meaningful participation in MIPS,” they wrote.

The current MIPS threshold excludes any physician or practice that generates $90,000 or less in Part B billing or sees 200 or fewer Medicare patients. The agency had initially set the threshold lower, at $30,000 or less in billing or 100 patients but created a larger exemption based on feedback from many physician groups.

The five members of the House GOP Doctors Caucus who signed on to the letter are Phil Roe (Tenn.), Andy Harris (Md.), Earl “Buddy” Carter (Ga.), Larry Bucshon (Ind.), and Scott DesJarlais (Tenn.).

[email protected]

The House GOP Doctors Caucus is pushing officials at the Centers for Medicare & Medicaid to lower the exclusion threshold for participation in the Merit-Based Incentive Payment System (MIPS).

In a letter to CMS Administrator Seema Verma, the lawmakers noted that about 60% of health care providers are excluded from MIPS – one track of the agency’s Quality Payment Program – mostly because of the high participation threshold set by the agency.

TheaDesign/Thinkstock

Since the program provides incentive payments to doctors by shifting Medicare Part B payments, the low participation is also lowering the payments available for high-level performance.

“The most notable ramification of the current threshold has been lower maximum positive updates on how MIPS ultimately adjusts Part B payments,” the lawmakers wrote. “For example, high performers are estimated to receive an aggregate payment adjustment in 2019 of 1.1% – based on their 2017 performance – even though adjustments of up to 4% are authorized.”

This payment trend “fails to incentivize meaningful participation in MIPS,” they wrote.

The current MIPS threshold excludes any physician or practice that generates $90,000 or less in Part B billing or sees 200 or fewer Medicare patients. The agency had initially set the threshold lower, at $30,000 or less in billing or 100 patients but created a larger exemption based on feedback from many physician groups.

The five members of the House GOP Doctors Caucus who signed on to the letter are Phil Roe (Tenn.), Andy Harris (Md.), Earl “Buddy” Carter (Ga.), Larry Bucshon (Ind.), and Scott DesJarlais (Tenn.).

[email protected]

SAN DIEGO – After an opioid-related overdose, intentions to reduce opioid use or injection are often complicated by unmanaged withdrawal symptoms and perceptions of disrespect from first responders and/or hospital staff, results from a small, exploratory study suggest.

“The opportunity for getting someone out of an overdose experience and into harm reduction, medication-assisted treatment, whatever it may be, is great,” lead study author Luther C. Elliott, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “But the stigmatizing experiences of survivors tend to lead them in a beeline out of the emergency department.”

Doug Brunk/MDedge News

In an effort to better understand the impacts of nonfatal overdose on subsequent substance abuse patterns and overdose risk behaviors, Alex S. Bennett, PhD, Dr. Elliott, and Brett Wolfson-Stofko, PhD, interviewed 20 recent overdose survivors about their experiences. All study participants had been administered naloxone by a professional first responder and taken to an emergency department via ambulance. Next, the researchers juxtaposed their narratives with perspectives from nine emergency medical technicians (EMTs), six emergency department staff members, and six medical staff members.

“Each stakeholder was asked about their experiences with opioid-involved overdose and about the potential for staging effective interventions with persons who have been recently reversed,” explained Dr. Elliott, a medical anthropologist at the New York City–based National Development and Research Institutes.

The researchers found that 67% of EMT/emergency medical services (EMS) personnel had a history of discussing opioid-related overdose or need for treatment, while 57% had self-reported fatigue or burnout with opioid-related overdose patients. For example, one EMT/EMS study participant described responding to overdose calls as taxing. “It takes away from what I would call real patients. …When I hear you took this drug by yourself and I have to go save [you], how is that fair?”

All nine emergency medicine physicians queried had a history of intervening and self-reported fatigue or burnout with opioid-related overdose patients. One physician response was as follows: “If I’m going to see the same person over and over again, I’ve tried my best to help you and you go back to the same thing over and over again, at some point, I’m not going to have any compassion.”

Of the 20 survivors, 30% indicated no reported change in their behavioral disposition after the overdose, 10% reported delayed change, and 60% reported immediate change. Barriers to change, expressed by some of the survivors, included receiving higher doses of naloxone than necessary to reverse an opioid-related overdose, and perceived disrespect from emergency department staff. For example, one survivor contended that hospital staff “left me in the hallway. I kept asking for water and they’re like, ‘We have none.’ They brought me some ice chips finally to shut me up, because I kept trying to walk out.”

Dr. Elliott said he was surprised to learn how much EMS staff and emergency medicine physicians attempted informal interventions by just talking with survivors. “They’ve used a combination of shaming techniques, like, ‘Do you realize you almost died? You’ve got to stop using drugs.’ The stigmatizing attitudes combined with the willingness and the desire to intervene were most surprising to me. There is a great opportunity here for psychotherapeutic knowledge to bear on how we interact with overdose survivors.”

In their abstract, he and his associates wrote that providing stakeholders “with even a brief general introduction to psychosocial interventions and sample scripts of supportive, motivational, and nonstigmatizing conversations between caregivers and the people experiencing opioid dependency may represent a positive advance in this direction.”

The study was funded by the National Institute on Drug Abuse. The authors reported having no financial disclosures and said the study content is solely their responsibility – and does not necessarily represent the official views of the National Institutes of Health.

[email protected]

SAN DIEGO – After an opioid-related overdose, intentions to reduce opioid use or injection are often complicated by unmanaged withdrawal symptoms and perceptions of disrespect from first responders and/or hospital staff, results from a small, exploratory study suggest.

“The opportunity for getting someone out of an overdose experience and into harm reduction, medication-assisted treatment, whatever it may be, is great,” lead study author Luther C. Elliott, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “But the stigmatizing experiences of survivors tend to lead them in a beeline out of the emergency department.”

Doug Brunk/MDedge News

In an effort to better understand the impacts of nonfatal overdose on subsequent substance abuse patterns and overdose risk behaviors, Alex S. Bennett, PhD, Dr. Elliott, and Brett Wolfson-Stofko, PhD, interviewed 20 recent overdose survivors about their experiences. All study participants had been administered naloxone by a professional first responder and taken to an emergency department via ambulance. Next, the researchers juxtaposed their narratives with perspectives from nine emergency medical technicians (EMTs), six emergency department staff members, and six medical staff members.

“Each stakeholder was asked about their experiences with opioid-involved overdose and about the potential for staging effective interventions with persons who have been recently reversed,” explained Dr. Elliott, a medical anthropologist at the New York City–based National Development and Research Institutes.

The researchers found that 67% of EMT/emergency medical services (EMS) personnel had a history of discussing opioid-related overdose or need for treatment, while 57% had self-reported fatigue or burnout with opioid-related overdose patients. For example, one EMT/EMS study participant described responding to overdose calls as taxing. “It takes away from what I would call real patients. …When I hear you took this drug by yourself and I have to go save [you], how is that fair?”

All nine emergency medicine physicians queried had a history of intervening and self-reported fatigue or burnout with opioid-related overdose patients. One physician response was as follows: “If I’m going to see the same person over and over again, I’ve tried my best to help you and you go back to the same thing over and over again, at some point, I’m not going to have any compassion.”

Of the 20 survivors, 30% indicated no reported change in their behavioral disposition after the overdose, 10% reported delayed change, and 60% reported immediate change. Barriers to change, expressed by some of the survivors, included receiving higher doses of naloxone than necessary to reverse an opioid-related overdose, and perceived disrespect from emergency department staff. For example, one survivor contended that hospital staff “left me in the hallway. I kept asking for water and they’re like, ‘We have none.’ They brought me some ice chips finally to shut me up, because I kept trying to walk out.”

Dr. Elliott said he was surprised to learn how much EMS staff and emergency medicine physicians attempted informal interventions by just talking with survivors. “They’ve used a combination of shaming techniques, like, ‘Do you realize you almost died? You’ve got to stop using drugs.’ The stigmatizing attitudes combined with the willingness and the desire to intervene were most surprising to me. There is a great opportunity here for psychotherapeutic knowledge to bear on how we interact with overdose survivors.”

In their abstract, he and his associates wrote that providing stakeholders “with even a brief general introduction to psychosocial interventions and sample scripts of supportive, motivational, and nonstigmatizing conversations between caregivers and the people experiencing opioid dependency may represent a positive advance in this direction.”

The study was funded by the National Institute on Drug Abuse. The authors reported having no financial disclosures and said the study content is solely their responsibility – and does not necessarily represent the official views of the National Institutes of Health.

[email protected]

SAN DIEGO – After an opioid-related overdose, intentions to reduce opioid use or injection are often complicated by unmanaged withdrawal symptoms and perceptions of disrespect from first responders and/or hospital staff, results from a small, exploratory study suggest.

“The opportunity for getting someone out of an overdose experience and into harm reduction, medication-assisted treatment, whatever it may be, is great,” lead study author Luther C. Elliott, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “But the stigmatizing experiences of survivors tend to lead them in a beeline out of the emergency department.”

Doug Brunk/MDedge News

In an effort to better understand the impacts of nonfatal overdose on subsequent substance abuse patterns and overdose risk behaviors, Alex S. Bennett, PhD, Dr. Elliott, and Brett Wolfson-Stofko, PhD, interviewed 20 recent overdose survivors about their experiences. All study participants had been administered naloxone by a professional first responder and taken to an emergency department via ambulance. Next, the researchers juxtaposed their narratives with perspectives from nine emergency medical technicians (EMTs), six emergency department staff members, and six medical staff members.

“Each stakeholder was asked about their experiences with opioid-involved overdose and about the potential for staging effective interventions with persons who have been recently reversed,” explained Dr. Elliott, a medical anthropologist at the New York City–based National Development and Research Institutes.

The researchers found that 67% of EMT/emergency medical services (EMS) personnel had a history of discussing opioid-related overdose or need for treatment, while 57% had self-reported fatigue or burnout with opioid-related overdose patients. For example, one EMT/EMS study participant described responding to overdose calls as taxing. “It takes away from what I would call real patients. …When I hear you took this drug by yourself and I have to go save [you], how is that fair?”

All nine emergency medicine physicians queried had a history of intervening and self-reported fatigue or burnout with opioid-related overdose patients. One physician response was as follows: “If I’m going to see the same person over and over again, I’ve tried my best to help you and you go back to the same thing over and over again, at some point, I’m not going to have any compassion.”

Of the 20 survivors, 30% indicated no reported change in their behavioral disposition after the overdose, 10% reported delayed change, and 60% reported immediate change. Barriers to change, expressed by some of the survivors, included receiving higher doses of naloxone than necessary to reverse an opioid-related overdose, and perceived disrespect from emergency department staff. For example, one survivor contended that hospital staff “left me in the hallway. I kept asking for water and they’re like, ‘We have none.’ They brought me some ice chips finally to shut me up, because I kept trying to walk out.”

Dr. Elliott said he was surprised to learn how much EMS staff and emergency medicine physicians attempted informal interventions by just talking with survivors. “They’ve used a combination of shaming techniques, like, ‘Do you realize you almost died? You’ve got to stop using drugs.’ The stigmatizing attitudes combined with the willingness and the desire to intervene were most surprising to me. There is a great opportunity here for psychotherapeutic knowledge to bear on how we interact with overdose survivors.”

In their abstract, he and his associates wrote that providing stakeholders “with even a brief general introduction to psychosocial interventions and sample scripts of supportive, motivational, and nonstigmatizing conversations between caregivers and the people experiencing opioid dependency may represent a positive advance in this direction.”

The study was funded by the National Institute on Drug Abuse. The authors reported having no financial disclosures and said the study content is solely their responsibility – and does not necessarily represent the official views of the National Institutes of Health.

[email protected]

Documentation got you down? Feel like you’re turning into a data entry clerk?

Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.

1. Tiers for Tots

PRImageFactory/iStock/Getty Images

“What are the parents like?” I ask.

“They’re great!” Tracy says. “They want their kids to be creative and play.”

She frowns. “But my boss insists I give him data.”

“Data? What data?”

“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”

“And what if the kids flub letter recognition?”

Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”

“Good grief! What is a Tier 2 intervention?”

“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”

Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!

2. Filing for firefighters

Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.

“The paperwork is driving me crazy,” he says.

“What paperwork?”

“In between calls, we spend hours filling out forms,” he says.

“Which forms?”

“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.

“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”

“And now?”

“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”

And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.

3. Your personal banker doesn’t know you!

Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”

I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”

“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”

“Sounds reasonable.”

“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”

“Do the regulators ever ask?”

“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

Documentation got you down? Feel like you’re turning into a data entry clerk?

Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.

1. Tiers for Tots

PRImageFactory/iStock/Getty Images

“What are the parents like?” I ask.

“They’re great!” Tracy says. “They want their kids to be creative and play.”

She frowns. “But my boss insists I give him data.”

“Data? What data?”

“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”

“And what if the kids flub letter recognition?”

Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”

“Good grief! What is a Tier 2 intervention?”

“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”

Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!

2. Filing for firefighters

Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.

“The paperwork is driving me crazy,” he says.

“What paperwork?”

“In between calls, we spend hours filling out forms,” he says.

“Which forms?”

“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.

“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”

“And now?”

“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”

And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.

3. Your personal banker doesn’t know you!

Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”

I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”

“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”

“Sounds reasonable.”

“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”

“Do the regulators ever ask?”

“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

Documentation got you down? Feel like you’re turning into a data entry clerk?

Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.

1. Tiers for Tots

PRImageFactory/iStock/Getty Images

“What are the parents like?” I ask.

“They’re great!” Tracy says. “They want their kids to be creative and play.”

She frowns. “But my boss insists I give him data.”

“Data? What data?”

“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”

“And what if the kids flub letter recognition?”

Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”

“Good grief! What is a Tier 2 intervention?”

“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”

Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!

2. Filing for firefighters

Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.

“The paperwork is driving me crazy,” he says.

“What paperwork?”

“In between calls, we spend hours filling out forms,” he says.

“Which forms?”

“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.

“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”

“And now?”

“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”

And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.

3. Your personal banker doesn’t know you!

Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”

I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”

“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”

“Sounds reasonable.”

“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”

“Do the regulators ever ask?”

“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

BALTIMORE – Multiple studies based on phase 3 clinical trials of the investigational drug solriamfetol have found that it may be effective for improving next-day wakefulness and work productivity in people with narcolepsy and obstructive sleep apnea, and that the drug can maintain its effect throughout the day as well as for up to 6 months, investigators reported at the annual meeting of the Associated Professional Sleep Societies.

Solriamfetol, developed by Jazz Pharmaceuticals, is the subject of a new drug application accepted by the Food and Drug Administration in March of 2018 for the treatment of excessive sleepiness due to narcolepsy or obstructive sleep apnea (OSA). Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor.

The drug was the subject of four different studies presented at SLEEP 2018 that drilled down into its effect on specific aspects of narcolepsy or OSA, or both. One study explored results in narcoleptic patients with and without cataplexy. Another study investigated the drug’s maintenance of efficacy after 6 months of treatment. A third study looked at the drug’s impact on next-day function, work productivity, and quality of life in patients with narcolepsy. And the fourth study researched how solriamfetol helped maintain wakefulness throughout the day.

Yves Dauvilliers, MD, reported that the 150- and 300-mg doses of solriamfetol were effective in improving both sleep latency, as measured with maintenance of wakefulness test (MWT), and Epworth Sleepiness Scale (ESS) scores in both cataplexic (n = 117) and noncataplexic (n = 114) narcolepsy. The objective of the study was to reevaluate the safety of solriamfetol in these narcoleptic subgroups from the phase 3 trial, said Dr. Dauvilliers, a faculty member at Centre Hospitalier Universitaire de Montpellier (France).

In patients with cataplexy, the 150-mg dose increased sleep latency from a baseline of 0 to 7.9 after a week and sustained that for 12 weeks; doubling the dose raised that to 10.3 after a week, reaching 10.7 in week 12. Gains were even more dramatic in noncataplexic patients, with the 150-mg dose improving sleep latency to 12.8 at week 1 and 11.6 at week 12, and the 300-mg dose resulting in a gain of 16.8 after a week, trailing off to 13.8 after 12 weeks, Dr. Dauvilliers said.

The study also evaluated ESS scores for three dosing levels – 75, 150, and 300 mg – plus placebo. In the group with cataplexy, ESS at week 12 improved from a baseline of 0 to –3.1, –5.6, and –6.3 for the three dosing groups, respectively, vs. –1.8 for placebo. In the noncataplexy patients with narcolepsy, the improvements in ESS at week 12 were –4.5, –5.2 and –6.4, respectively, vs. –1.5 for placebo.

“At 150 mg and 300 mg, solriamfetol seems to be very effective in treating excessive sleepiness with narcolepsy, with the same efficacy in the group with and without cataplexy – with efficacy even after just 1 week of treatment,” Dr. Dauvilliers said.

Atul Malhotra, MD, and his coresearchers investigated the long-term safety and efficacy of solriamfetol out to 42 weeks in patients with narcolepsy or OSA who completed previous clinical trials, which were 6- and 12-week trials. The study involved an open-label phase from weeks 14 to 27, a 2-week randomized withdrawal phase and then safety follow-up after week 40. In the open-label phase, ESS scores for the overall treatment group (n = 519) improved from 15.9 at baseline to 8.3 at week 40, with variation between the OSA (n = 333) and narcolepsy (n = 186) groups: from 15.2 at baseline to 6.5 at week 40 for the former and from 17.3 to 11.4 for the latter.

In the randomized withdrawal phase, ESS scores for those on solriamfetol (n = 139) migrated upward from 7.3 to 8.5 – but for the placebo group (n = 141) ESS rose from 7.8 to 12.6, a difference of 3.7 favoring the treatment group, said Dr. Malhotra, chief of pulmonary and critical care medicine and the Kenneth M. Moser Professor in the department of medicine, University of California San Diego, La Jolla. Most patients in the placebo group had worsening of symptoms based on global impression of change – 64.5% vs. 28.2% in the treatment group in the self-reported cohort, and 63.8% vs. 28.7% in the clinician-evaluated cohort.

SOURCE: Dauvilliers Y et al. Abstract 0619; Malhotra A et al. Abstract 0620; Emsellem H et al. Abstract 0621; Schweitzer PK et al. Abstract 0622. Presented at Sleep 2018.

BALTIMORE – Multiple studies based on phase 3 clinical trials of the investigational drug solriamfetol have found that it may be effective for improving next-day wakefulness and work productivity in people with narcolepsy and obstructive sleep apnea, and that the drug can maintain its effect throughout the day as well as for up to 6 months, investigators reported at the annual meeting of the Associated Professional Sleep Societies.

Solriamfetol, developed by Jazz Pharmaceuticals, is the subject of a new drug application accepted by the Food and Drug Administration in March of 2018 for the treatment of excessive sleepiness due to narcolepsy or obstructive sleep apnea (OSA). Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor.

The drug was the subject of four different studies presented at SLEEP 2018 that drilled down into its effect on specific aspects of narcolepsy or OSA, or both. One study explored results in narcoleptic patients with and without cataplexy. Another study investigated the drug’s maintenance of efficacy after 6 months of treatment. A third study looked at the drug’s impact on next-day function, work productivity, and quality of life in patients with narcolepsy. And the fourth study researched how solriamfetol helped maintain wakefulness throughout the day.

Yves Dauvilliers, MD, reported that the 150- and 300-mg doses of solriamfetol were effective in improving both sleep latency, as measured with maintenance of wakefulness test (MWT), and Epworth Sleepiness Scale (ESS) scores in both cataplexic (n = 117) and noncataplexic (n = 114) narcolepsy. The objective of the study was to reevaluate the safety of solriamfetol in these narcoleptic subgroups from the phase 3 trial, said Dr. Dauvilliers, a faculty member at Centre Hospitalier Universitaire de Montpellier (France).

In patients with cataplexy, the 150-mg dose increased sleep latency from a baseline of 0 to 7.9 after a week and sustained that for 12 weeks; doubling the dose raised that to 10.3 after a week, reaching 10.7 in week 12. Gains were even more dramatic in noncataplexic patients, with the 150-mg dose improving sleep latency to 12.8 at week 1 and 11.6 at week 12, and the 300-mg dose resulting in a gain of 16.8 after a week, trailing off to 13.8 after 12 weeks, Dr. Dauvilliers said.

The study also evaluated ESS scores for three dosing levels – 75, 150, and 300 mg – plus placebo. In the group with cataplexy, ESS at week 12 improved from a baseline of 0 to –3.1, –5.6, and –6.3 for the three dosing groups, respectively, vs. –1.8 for placebo. In the noncataplexy patients with narcolepsy, the improvements in ESS at week 12 were –4.5, –5.2 and –6.4, respectively, vs. –1.5 for placebo.

“At 150 mg and 300 mg, solriamfetol seems to be very effective in treating excessive sleepiness with narcolepsy, with the same efficacy in the group with and without cataplexy – with efficacy even after just 1 week of treatment,” Dr. Dauvilliers said.

Atul Malhotra, MD, and his coresearchers investigated the long-term safety and efficacy of solriamfetol out to 42 weeks in patients with narcolepsy or OSA who completed previous clinical trials, which were 6- and 12-week trials. The study involved an open-label phase from weeks 14 to 27, a 2-week randomized withdrawal phase and then safety follow-up after week 40. In the open-label phase, ESS scores for the overall treatment group (n = 519) improved from 15.9 at baseline to 8.3 at week 40, with variation between the OSA (n = 333) and narcolepsy (n = 186) groups: from 15.2 at baseline to 6.5 at week 40 for the former and from 17.3 to 11.4 for the latter.

In the randomized withdrawal phase, ESS scores for those on solriamfetol (n = 139) migrated upward from 7.3 to 8.5 – but for the placebo group (n = 141) ESS rose from 7.8 to 12.6, a difference of 3.7 favoring the treatment group, said Dr. Malhotra, chief of pulmonary and critical care medicine and the Kenneth M. Moser Professor in the department of medicine, University of California San Diego, La Jolla. Most patients in the placebo group had worsening of symptoms based on global impression of change – 64.5% vs. 28.2% in the treatment group in the self-reported cohort, and 63.8% vs. 28.7% in the clinician-evaluated cohort.

SOURCE: Dauvilliers Y et al. Abstract 0619; Malhotra A et al. Abstract 0620; Emsellem H et al. Abstract 0621; Schweitzer PK et al. Abstract 0622. Presented at Sleep 2018.

BALTIMORE – Multiple studies based on phase 3 clinical trials of the investigational drug solriamfetol have found that it may be effective for improving next-day wakefulness and work productivity in people with narcolepsy and obstructive sleep apnea, and that the drug can maintain its effect throughout the day as well as for up to 6 months, investigators reported at the annual meeting of the Associated Professional Sleep Societies.

Solriamfetol, developed by Jazz Pharmaceuticals, is the subject of a new drug application accepted by the Food and Drug Administration in March of 2018 for the treatment of excessive sleepiness due to narcolepsy or obstructive sleep apnea (OSA). Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor.

The drug was the subject of four different studies presented at SLEEP 2018 that drilled down into its effect on specific aspects of narcolepsy or OSA, or both. One study explored results in narcoleptic patients with and without cataplexy. Another study investigated the drug’s maintenance of efficacy after 6 months of treatment. A third study looked at the drug’s impact on next-day function, work productivity, and quality of life in patients with narcolepsy. And the fourth study researched how solriamfetol helped maintain wakefulness throughout the day.

Yves Dauvilliers, MD, reported that the 150- and 300-mg doses of solriamfetol were effective in improving both sleep latency, as measured with maintenance of wakefulness test (MWT), and Epworth Sleepiness Scale (ESS) scores in both cataplexic (n = 117) and noncataplexic (n = 114) narcolepsy. The objective of the study was to reevaluate the safety of solriamfetol in these narcoleptic subgroups from the phase 3 trial, said Dr. Dauvilliers, a faculty member at Centre Hospitalier Universitaire de Montpellier (France).

In patients with cataplexy, the 150-mg dose increased sleep latency from a baseline of 0 to 7.9 after a week and sustained that for 12 weeks; doubling the dose raised that to 10.3 after a week, reaching 10.7 in week 12. Gains were even more dramatic in noncataplexic patients, with the 150-mg dose improving sleep latency to 12.8 at week 1 and 11.6 at week 12, and the 300-mg dose resulting in a gain of 16.8 after a week, trailing off to 13.8 after 12 weeks, Dr. Dauvilliers said.

The study also evaluated ESS scores for three dosing levels – 75, 150, and 300 mg – plus placebo. In the group with cataplexy, ESS at week 12 improved from a baseline of 0 to –3.1, –5.6, and –6.3 for the three dosing groups, respectively, vs. –1.8 for placebo. In the noncataplexy patients with narcolepsy, the improvements in ESS at week 12 were –4.5, –5.2 and –6.4, respectively, vs. –1.5 for placebo.

“At 150 mg and 300 mg, solriamfetol seems to be very effective in treating excessive sleepiness with narcolepsy, with the same efficacy in the group with and without cataplexy – with efficacy even after just 1 week of treatment,” Dr. Dauvilliers said.

Atul Malhotra, MD, and his coresearchers investigated the long-term safety and efficacy of solriamfetol out to 42 weeks in patients with narcolepsy or OSA who completed previous clinical trials, which were 6- and 12-week trials. The study involved an open-label phase from weeks 14 to 27, a 2-week randomized withdrawal phase and then safety follow-up after week 40. In the open-label phase, ESS scores for the overall treatment group (n = 519) improved from 15.9 at baseline to 8.3 at week 40, with variation between the OSA (n = 333) and narcolepsy (n = 186) groups: from 15.2 at baseline to 6.5 at week 40 for the former and from 17.3 to 11.4 for the latter.

In the randomized withdrawal phase, ESS scores for those on solriamfetol (n = 139) migrated upward from 7.3 to 8.5 – but for the placebo group (n = 141) ESS rose from 7.8 to 12.6, a difference of 3.7 favoring the treatment group, said Dr. Malhotra, chief of pulmonary and critical care medicine and the Kenneth M. Moser Professor in the department of medicine, University of California San Diego, La Jolla. Most patients in the placebo group had worsening of symptoms based on global impression of change – 64.5% vs. 28.2% in the treatment group in the self-reported cohort, and 63.8% vs. 28.7% in the clinician-evaluated cohort.

SOURCE: Dauvilliers Y et al. Abstract 0619; Malhotra A et al. Abstract 0620; Emsellem H et al. Abstract 0621; Schweitzer PK et al. Abstract 0622. Presented at Sleep 2018.

ABSTRACT

An increasing interest focuses on the rates and risk factors for hospital readmission. However, little is known regarding the readmission following total shoulder arthroplasty (TSA). This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA. Patients undergoing TSA (anatomic or reverse) as part of the American College of Surgeons National Surgical Quality Improvement Program in 2011 to 2013 were identified. The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. Using multivariate regression, demographic and comorbidity factors were tested for independent association with readmission. Finally, the reasons for readmission were characterized. A total of 3627 patients were identified. Among the admitted patients, 93 (2.56%) were readmitted within 30 days of surgery. The independent risk factors for readmission included old age (for age 60-69 years, relative risk [RR] = 1.6; for age 70-79 years, RR = 2.3; for age ≥80 years, RR = 23.1; P = .042), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission comprised pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%). Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at higher risk for readmission and should be counseled and monitored accordingly.

Continue to: Total shoulder arthroplasty...

Total shoulder arthroplasty (TSA) is performed with increasing frequency in the United States and is considered to be cost-effective.^1-4 Following the procedure, patients generally achieve shoulder function and pain relief.^5-8 Despite the success of the procedure, the growing literature on TSA has also reported rates of complications between 3.6% and 25% of the treated patients.^9-16

In recent years, an increasing interest has focused on the rates and risk factors for unplanned hospital readmissions; these variables may not only reflect the quality of patient care but also result in considerable costs to the healthcare system. For instance, among Medicare patients, readmissions within 30 days of discharge occur in almost 20% of cases, costing $17.4 billion per year.¹⁷ Readmission rates increasingly factor into hospital performance metrics and reimbursement, including the Hospital Readmissions Reduction Program of the Patient Protection and Affordable Care Act that reduces Centers for Medicare and Medicaid Services payments to hospitals with high 30-day readmission rates.¹⁸

To date, only a few studies have evaluated readmission following TSA, with 30- to 90-day readmission rates ranging from 4.5% to 7.3%.^19-23 These studies comprised single institution series^20,22 and analyses of administrative databases.^19,21,23 Most studies have shown that readmission occurs more often for medical than surgical reasons, with surgical reasons most commonly including infection and dislocation.^19-23 However, only limited analyses have been conducted regarding risk factors for readmission.^21,23 To date and to our knowledge, no study has investigated reasons for readmission following TSA using nationwide data.

This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA in the United States using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database.

METHODS

DATA SOURCE

The NSQIP database was utilized to address the study purpose. NSQIP is a nationwide prospective surgical registry established by the American College of Surgeons and reports data from academic and community hospitals across the United States.²⁴ Patients undertaking surgery at these centers are followed by the surgical clinical reviewers at the participating NSQIP sites prospectively for 30 days following the procedure to record complications including readmission. Preoperative and surgical data, such as demographics, medical comorbid diseases, and operative time, are also included. Previous studies have analyzed the complications of various orthopedic surgeries using the NSQIP data.^14,16,25-30

DATA COLLECTION

We retrospectively identified from NSQIP the patients who underwent primary TSA (anatomic or reverse) in 2013 to 2014. The timeframe 2013 to 2014 was used because NSQIP only began recording reasons for readmission in 2013. The inclusion criteria were as follows: Current Procedural Terminology (CPT) code for TSA (23472); preoperative diagnosis according to the International Classification of Diseases, Ninth Revision (ICD-9) codes 714.0, 715.11, 715.31, 715.91, 715.21, 715.89, 716.xx 718.xx, 719.xx, 726.x, 727.xx, and 733.41 (where x is a wild card digit); and no missing demographic, comorbidity, or outcome data. Anatomic and reverse TSA were analyzed together because they share the same CPT code, and the NSQIP database prevents searching by the ICD-9 procedure code.

The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. The reasons for readmission in this 30-day period were only available in 2013 and were determined using the ICD-9 diagnosis codes. Patient demographics were recorded for use in identifying potential risk factors for readmission; the demographic data included sex, age, smoking status, body mass index (BMI), and comorbidities, including end-stage renal disease, dyspnea on exertion, congestive heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease (COPD).

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

Statistical analyses were performed using Stata version 13.1 (StataCorp). First, using bivariate and multivariate regression, demographic and comorbidity factors were tested for independent association with readmission to the hospital within 30 days of surgery. Second, among the readmitted patients, the reasons for readmission were tabulated. Of note, the reasons for readmission were only documented for the procedures performed in 2013. All tests were 2-tailed and conducted at an α level of 0.05.

RESTULTS

A total of 3627 TSA patients were identified. The mean age (± standard deviation) was 69.4 ± 9.5 years, 55.8% of patients were female, and mean BMI was 30.1 ± 7.0 years. Table 1 provides the additional demographic data. Of the 3627 included patients, 93 (2.56%) were readmitted within 30 days of surgery. The 95% confidence interval for the estimated rate of readmission reached 2.05% to 3.08%.

Table 1. Patient Population

Abbreviation: COPD, chronic obstructive pulmonary disease.

In the bivariate analyses (Table 2), the following factors were positively associated readmission: older age (60-69 years, relative risk [RR] = 1.6; 70-79 years, RR = 2.2; ≥80 years, RR = 3.3; P = .011), dependent functional status (RR = 2.9, P = .008), and anemia (RR = 2.2, P < .001).

Table 2. Bivariate Analysis of Risk Factors for Readmission

Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.

In the multivariate analyses (Table 3), the following factors were independent risk factors for readmission: older age (60-69 years, RR = 1.6; 70-79 years, RR = 2.3; ≥80 years, RR = 3.1; P =.027), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). Interestingly, readmission showed no independent association with diabetes, dyspnea on exertion, BMI, COPD, hypertension, or current smoking status (P > .05 for each).

Table 3. Independent Risk Factors for Readmission on Multivariate Analysis

Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.

Continue to: Table 4...

The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission included pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%) (Table 4).

Table 4. Reasons for Readmission

DISCUSSION

Our analysis of 3042 TSAs from the NSQIP database suggests that unplanned readmission to the hospital occurs following about 1 in 40 cases of TSA. The study also suggests that the most common reasons for readmission encompass pneumonia, dislocation, pulmonary embolism, and surgical site infection. Old age, male sex, anemia, and dependent functional status serve as risk factors for readmission, and patients with such factors should be counseled and monitored accordingly.

In recent years, an increasing emphasis has centered on reducing rates of hospital readmission, with programs such as the Hospital Readmissions Reduction Program of the Affordable Care Act cutting reimbursements for hospitals with high 30-day readmission rates.^17,18 To date, only a few studies have evaluated the reasons for readmission and readmission rates for TSA.^19-23 Initial reports consisted of single-institution TSA registry reviews. For example, Mahoney and colleagues²⁰ retrospectively evaluated shoulder arthroplasty procedures at their institution to document the readmission rates, finding a 5.9% readmission rate at 30 days. Readmission occurred more frequently in the first 30 days following discharge than in the 30- to 90-day period, with the most common reasons for readmission including medical complications, infection, and dislocation. Streubel and colleagues²² evaluated reoperation rates from their institution’s TSA registry, finding a 0.6% reoperation rate for primary TSA at 30 days and 1.5% for revision TSA. Instability and infection were the most common indications for reoperation. Our findings confirm these single-institution results and demonstrate their application to a nationwide sample of TSA, not just to high-volume academic centers. We similarly observed that dislocation, surgical site infection, and medical complications (mostly pneumonia and pulmonary embolism) were common causes of readmission, and that the 30-day readmission rate was about 1 in 40.

Several authors have since used statewide databases to analyze and determine risk factors for readmission following TSA. Lyman and colleagues¹⁹ used the New York State Database to show that higher hospital TSA surgical volume was associated with a lower rate of readmission when age and comorbidities were controlled for in a multivariate model. Old age was also associated with an increased readmission rate in their multivariate analysis, but comorbidities (as measured by the Charlson comorbidity index) presented a nonsignificant associative trend. These authors opted not to determine specific causes of readmission. Schairer and colleagues²¹ used State Inpatient Databases from 7 states, finding a 90-day readmission rate of 7.3%, 82% of which were due to medical complications and 18% of which were due to surgical complications (mostly infection and dislocation). Their multivariate regression revealed that male sex, reverse TSA, Medicaid insurance, patients discharged to inpatient rehabilitation or nursing facilities, medical comorbidities, and low-volume TSA hospitals were associated with readmission. Zhang and colleagues²³ used the same source to show that the 90-day readmission rate reached 14% for surgically treated proximal humerus fractures and higher for patients who underwent open reduction internal fixation, were female, were African American, were discharged to a nursing facility, possessed Medicaid insurance, or experienced medical comorbidities. Most recently, Basques and colleagues³¹ analyzed 1505 TSA cases from 2011 and 2012 in the NSQIP database, finding a 3.3% rate of readmission, with heart disease and hypertension as risk factors for readmission. Although the limitations of the NSQIP database prevented us from analyzing surgeon and hospital TSA volume or reverse vs anatomic TSA, our results confirm that the findings from statewide database studies apply to the United States nationwide NSQIP database. Old patient age, male sex, and medical comorbidities (anemia and dependent functional status) are independent risk factors for TSA readmission. We identified pneumonia, dislocation, pulmonary embolism, and surgical site infection as the most common reasons for readmission.

This study features several limitations that should be considered when interpreting the results. Anatomic and reverse TSA share a CPT code and were not separated using NSQIP data. A number of studies have reported that reverse TSA may place patients at higher risk for readmission;^20,21 however, confounding by other patient factors could play a role in this finding. The 30-day timeframe for readmission is another potential limitation; however, this timeframe is frequently used in other studies and is the relevant timeframe for the reduced reimbursement penalties from the Hospital Readmissions Reduction Program of the Affordable Care Act.¹⁸ Furthermore, the NSQIP database contains no information on surgeon or hospital TSA volume, which is a result of safeguards for patient and provider privacy. Additionally, readmission data were only available for 2011 to 2013, with causes of readmission only present in 2013. Although provided with such current information, we cannot analyze readmission trends over time, such as in response to the Affordable Care Act of 2010. Finally, although NSQIP surgical clinical reviewers strive to identify readmissions to other hospitals during their reviews of outpatient medical records, proportions of these readmissions are possibly missed. Therefore, our 30-day readmission rate may slightly underestimate the true rate.

Despite these limitations, the NSQIP database offers a unique opportunity to examine risk factors and reasons for readmission following TSA. The prior literature on readmission following TSA stemmed either from limited samples or administrative data, which feature known limitations.³² By utilizing a large, prospective, non-administrative, nationwide sample, our findings are probably both more reliable and generalizable to the country as a whole.

CONCLUSION

Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at a higher risk for readmission and should be counseled and monitored accordingly.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

An increasing interest focuses on the rates and risk factors for hospital readmission. However, little is known regarding the readmission following total shoulder arthroplasty (TSA). This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA. Patients undergoing TSA (anatomic or reverse) as part of the American College of Surgeons National Surgical Quality Improvement Program in 2011 to 2013 were identified. The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. Using multivariate regression, demographic and comorbidity factors were tested for independent association with readmission. Finally, the reasons for readmission were characterized. A total of 3627 patients were identified. Among the admitted patients, 93 (2.56%) were readmitted within 30 days of surgery. The independent risk factors for readmission included old age (for age 60-69 years, relative risk [RR] = 1.6; for age 70-79 years, RR = 2.3; for age ≥80 years, RR = 23.1; P = .042), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission comprised pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%). Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at higher risk for readmission and should be counseled and monitored accordingly.

Continue to: Total shoulder arthroplasty...

Total shoulder arthroplasty (TSA) is performed with increasing frequency in the United States and is considered to be cost-effective.^1-4 Following the procedure, patients generally achieve shoulder function and pain relief.^5-8 Despite the success of the procedure, the growing literature on TSA has also reported rates of complications between 3.6% and 25% of the treated patients.^9-16

In recent years, an increasing interest has focused on the rates and risk factors for unplanned hospital readmissions; these variables may not only reflect the quality of patient care but also result in considerable costs to the healthcare system. For instance, among Medicare patients, readmissions within 30 days of discharge occur in almost 20% of cases, costing $17.4 billion per year.¹⁷ Readmission rates increasingly factor into hospital performance metrics and reimbursement, including the Hospital Readmissions Reduction Program of the Patient Protection and Affordable Care Act that reduces Centers for Medicare and Medicaid Services payments to hospitals with high 30-day readmission rates.¹⁸

To date, only a few studies have evaluated readmission following TSA, with 30- to 90-day readmission rates ranging from 4.5% to 7.3%.^19-23 These studies comprised single institution series^20,22 and analyses of administrative databases.^19,21,23 Most studies have shown that readmission occurs more often for medical than surgical reasons, with surgical reasons most commonly including infection and dislocation.^19-23 However, only limited analyses have been conducted regarding risk factors for readmission.^21,23 To date and to our knowledge, no study has investigated reasons for readmission following TSA using nationwide data.

This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA in the United States using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database.

METHODS

DATA SOURCE

The NSQIP database was utilized to address the study purpose. NSQIP is a nationwide prospective surgical registry established by the American College of Surgeons and reports data from academic and community hospitals across the United States.²⁴ Patients undertaking surgery at these centers are followed by the surgical clinical reviewers at the participating NSQIP sites prospectively for 30 days following the procedure to record complications including readmission. Preoperative and surgical data, such as demographics, medical comorbid diseases, and operative time, are also included. Previous studies have analyzed the complications of various orthopedic surgeries using the NSQIP data.^14,16,25-30

DATA COLLECTION

We retrospectively identified from NSQIP the patients who underwent primary TSA (anatomic or reverse) in 2013 to 2014. The timeframe 2013 to 2014 was used because NSQIP only began recording reasons for readmission in 2013. The inclusion criteria were as follows: Current Procedural Terminology (CPT) code for TSA (23472); preoperative diagnosis according to the International Classification of Diseases, Ninth Revision (ICD-9) codes 714.0, 715.11, 715.31, 715.91, 715.21, 715.89, 716.xx 718.xx, 719.xx, 726.x, 727.xx, and 733.41 (where x is a wild card digit); and no missing demographic, comorbidity, or outcome data. Anatomic and reverse TSA were analyzed together because they share the same CPT code, and the NSQIP database prevents searching by the ICD-9 procedure code.

The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. The reasons for readmission in this 30-day period were only available in 2013 and were determined using the ICD-9 diagnosis codes. Patient demographics were recorded for use in identifying potential risk factors for readmission; the demographic data included sex, age, smoking status, body mass index (BMI), and comorbidities, including end-stage renal disease, dyspnea on exertion, congestive heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease (COPD).

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

Statistical analyses were performed using Stata version 13.1 (StataCorp). First, using bivariate and multivariate regression, demographic and comorbidity factors were tested for independent association with readmission to the hospital within 30 days of surgery. Second, among the readmitted patients, the reasons for readmission were tabulated. Of note, the reasons for readmission were only documented for the procedures performed in 2013. All tests were 2-tailed and conducted at an α level of 0.05.

RESTULTS

A total of 3627 TSA patients were identified. The mean age (± standard deviation) was 69.4 ± 9.5 years, 55.8% of patients were female, and mean BMI was 30.1 ± 7.0 years. Table 1 provides the additional demographic data. Of the 3627 included patients, 93 (2.56%) were readmitted within 30 days of surgery. The 95% confidence interval for the estimated rate of readmission reached 2.05% to 3.08%.

Table 1. Patient Population

Abbreviation: COPD, chronic obstructive pulmonary disease.

In the bivariate analyses (Table 2), the following factors were positively associated readmission: older age (60-69 years, relative risk [RR] = 1.6; 70-79 years, RR = 2.2; ≥80 years, RR = 3.3; P = .011), dependent functional status (RR = 2.9, P = .008), and anemia (RR = 2.2, P < .001).

Table 2. Bivariate Analysis of Risk Factors for Readmission

Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.

In the multivariate analyses (Table 3), the following factors were independent risk factors for readmission: older age (60-69 years, RR = 1.6; 70-79 years, RR = 2.3; ≥80 years, RR = 3.1; P =.027), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). Interestingly, readmission showed no independent association with diabetes, dyspnea on exertion, BMI, COPD, hypertension, or current smoking status (P > .05 for each).

Table 3. Independent Risk Factors for Readmission on Multivariate Analysis

Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.

Continue to: Table 4...

The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission included pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%) (Table 4).

Table 4. Reasons for Readmission

DISCUSSION

Our analysis of 3042 TSAs from the NSQIP database suggests that unplanned readmission to the hospital occurs following about 1 in 40 cases of TSA. The study also suggests that the most common reasons for readmission encompass pneumonia, dislocation, pulmonary embolism, and surgical site infection. Old age, male sex, anemia, and dependent functional status serve as risk factors for readmission, and patients with such factors should be counseled and monitored accordingly.

In recent years, an increasing emphasis has centered on reducing rates of hospital readmission, with programs such as the Hospital Readmissions Reduction Program of the Affordable Care Act cutting reimbursements for hospitals with high 30-day readmission rates.^17,18 To date, only a few studies have evaluated the reasons for readmission and readmission rates for TSA.^19-23 Initial reports consisted of single-institution TSA registry reviews. For example, Mahoney and colleagues²⁰ retrospectively evaluated shoulder arthroplasty procedures at their institution to document the readmission rates, finding a 5.9% readmission rate at 30 days. Readmission occurred more frequently in the first 30 days following discharge than in the 30- to 90-day period, with the most common reasons for readmission including medical complications, infection, and dislocation. Streubel and colleagues²² evaluated reoperation rates from their institution’s TSA registry, finding a 0.6% reoperation rate for primary TSA at 30 days and 1.5% for revision TSA. Instability and infection were the most common indications for reoperation. Our findings confirm these single-institution results and demonstrate their application to a nationwide sample of TSA, not just to high-volume academic centers. We similarly observed that dislocation, surgical site infection, and medical complications (mostly pneumonia and pulmonary embolism) were common causes of readmission, and that the 30-day readmission rate was about 1 in 40.

Several authors have since used statewide databases to analyze and determine risk factors for readmission following TSA. Lyman and colleagues¹⁹ used the New York State Database to show that higher hospital TSA surgical volume was associated with a lower rate of readmission when age and comorbidities were controlled for in a multivariate model. Old age was also associated with an increased readmission rate in their multivariate analysis, but comorbidities (as measured by the Charlson comorbidity index) presented a nonsignificant associative trend. These authors opted not to determine specific causes of readmission. Schairer and colleagues²¹ used State Inpatient Databases from 7 states, finding a 90-day readmission rate of 7.3%, 82% of which were due to medical complications and 18% of which were due to surgical complications (mostly infection and dislocation). Their multivariate regression revealed that male sex, reverse TSA, Medicaid insurance, patients discharged to inpatient rehabilitation or nursing facilities, medical comorbidities, and low-volume TSA hospitals were associated with readmission. Zhang and colleagues²³ used the same source to show that the 90-day readmission rate reached 14% for surgically treated proximal humerus fractures and higher for patients who underwent open reduction internal fixation, were female, were African American, were discharged to a nursing facility, possessed Medicaid insurance, or experienced medical comorbidities. Most recently, Basques and colleagues³¹ analyzed 1505 TSA cases from 2011 and 2012 in the NSQIP database, finding a 3.3% rate of readmission, with heart disease and hypertension as risk factors for readmission. Although the limitations of the NSQIP database prevented us from analyzing surgeon and hospital TSA volume or reverse vs anatomic TSA, our results confirm that the findings from statewide database studies apply to the United States nationwide NSQIP database. Old patient age, male sex, and medical comorbidities (anemia and dependent functional status) are independent risk factors for TSA readmission. We identified pneumonia, dislocation, pulmonary embolism, and surgical site infection as the most common reasons for readmission.

This study features several limitations that should be considered when interpreting the results. Anatomic and reverse TSA share a CPT code and were not separated using NSQIP data. A number of studies have reported that reverse TSA may place patients at higher risk for readmission;^20,21 however, confounding by other patient factors could play a role in this finding. The 30-day timeframe for readmission is another potential limitation; however, this timeframe is frequently used in other studies and is the relevant timeframe for the reduced reimbursement penalties from the Hospital Readmissions Reduction Program of the Affordable Care Act.¹⁸ Furthermore, the NSQIP database contains no information on surgeon or hospital TSA volume, which is a result of safeguards for patient and provider privacy. Additionally, readmission data were only available for 2011 to 2013, with causes of readmission only present in 2013. Although provided with such current information, we cannot analyze readmission trends over time, such as in response to the Affordable Care Act of 2010. Finally, although NSQIP surgical clinical reviewers strive to identify readmissions to other hospitals during their reviews of outpatient medical records, proportions of these readmissions are possibly missed. Therefore, our 30-day readmission rate may slightly underestimate the true rate.

Despite these limitations, the NSQIP database offers a unique opportunity to examine risk factors and reasons for readmission following TSA. The prior literature on readmission following TSA stemmed either from limited samples or administrative data, which feature known limitations.³² By utilizing a large, prospective, non-administrative, nationwide sample, our findings are probably both more reliable and generalizable to the country as a whole.

CONCLUSION

Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at a higher risk for readmission and should be counseled and monitored accordingly.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

An increasing interest focuses on the rates and risk factors for hospital readmission. However, little is known regarding the readmission following total shoulder arthroplasty (TSA). This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA. Patients undergoing TSA (anatomic or reverse) as part of the American College of Surgeons National Surgical Quality Improvement Program in 2011 to 2013 were identified. The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. Using multivariate regression, demographic and comorbidity factors were tested for independent association with readmission. Finally, the reasons for readmission were characterized. A total of 3627 patients were identified. Among the admitted patients, 93 (2.56%) were readmitted within 30 days of surgery. The independent risk factors for readmission included old age (for age 60-69 years, relative risk [RR] = 1.6; for age 70-79 years, RR = 2.3; for age ≥80 years, RR = 23.1; P = .042), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission comprised pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%). Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at higher risk for readmission and should be counseled and monitored accordingly.

Continue to: Total shoulder arthroplasty...

Total shoulder arthroplasty (TSA) is performed with increasing frequency in the United States and is considered to be cost-effective.^1-4 Following the procedure, patients generally achieve shoulder function and pain relief.^5-8 Despite the success of the procedure, the growing literature on TSA has also reported rates of complications between 3.6% and 25% of the treated patients.^9-16

In recent years, an increasing interest has focused on the rates and risk factors for unplanned hospital readmissions; these variables may not only reflect the quality of patient care but also result in considerable costs to the healthcare system. For instance, among Medicare patients, readmissions within 30 days of discharge occur in almost 20% of cases, costing $17.4 billion per year.¹⁷ Readmission rates increasingly factor into hospital performance metrics and reimbursement, including the Hospital Readmissions Reduction Program of the Patient Protection and Affordable Care Act that reduces Centers for Medicare and Medicaid Services payments to hospitals with high 30-day readmission rates.¹⁸

To date, only a few studies have evaluated readmission following TSA, with 30- to 90-day readmission rates ranging from 4.5% to 7.3%.^19-23 These studies comprised single institution series^20,22 and analyses of administrative databases.^19,21,23 Most studies have shown that readmission occurs more often for medical than surgical reasons, with surgical reasons most commonly including infection and dislocation.^19-23 However, only limited analyses have been conducted regarding risk factors for readmission.^21,23 To date and to our knowledge, no study has investigated reasons for readmission following TSA using nationwide data.

This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA in the United States using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database.

METHODS

DATA SOURCE

The NSQIP database was utilized to address the study purpose. NSQIP is a nationwide prospective surgical registry established by the American College of Surgeons and reports data from academic and community hospitals across the United States.²⁴ Patients undertaking surgery at these centers are followed by the surgical clinical reviewers at the participating NSQIP sites prospectively for 30 days following the procedure to record complications including readmission. Preoperative and surgical data, such as demographics, medical comorbid diseases, and operative time, are also included. Previous studies have analyzed the complications of various orthopedic surgeries using the NSQIP data.^14,16,25-30

DATA COLLECTION

We retrospectively identified from NSQIP the patients who underwent primary TSA (anatomic or reverse) in 2013 to 2014. The timeframe 2013 to 2014 was used because NSQIP only began recording reasons for readmission in 2013. The inclusion criteria were as follows: Current Procedural Terminology (CPT) code for TSA (23472); preoperative diagnosis according to the International Classification of Diseases, Ninth Revision (ICD-9) codes 714.0, 715.11, 715.31, 715.91, 715.21, 715.89, 716.xx 718.xx, 719.xx, 726.x, 727.xx, and 733.41 (where x is a wild card digit); and no missing demographic, comorbidity, or outcome data. Anatomic and reverse TSA were analyzed together because they share the same CPT code, and the NSQIP database prevents searching by the ICD-9 procedure code.

The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. The reasons for readmission in this 30-day period were only available in 2013 and were determined using the ICD-9 diagnosis codes. Patient demographics were recorded for use in identifying potential risk factors for readmission; the demographic data included sex, age, smoking status, body mass index (BMI), and comorbidities, including end-stage renal disease, dyspnea on exertion, congestive heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease (COPD).

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

Statistical analyses were performed using Stata version 13.1 (StataCorp). First, using bivariate and multivariate regression, demographic and comorbidity factors were tested for independent association with readmission to the hospital within 30 days of surgery. Second, among the readmitted patients, the reasons for readmission were tabulated. Of note, the reasons for readmission were only documented for the procedures performed in 2013. All tests were 2-tailed and conducted at an α level of 0.05.

RESTULTS

A total of 3627 TSA patients were identified. The mean age (± standard deviation) was 69.4 ± 9.5 years, 55.8% of patients were female, and mean BMI was 30.1 ± 7.0 years. Table 1 provides the additional demographic data. Of the 3627 included patients, 93 (2.56%) were readmitted within 30 days of surgery. The 95% confidence interval for the estimated rate of readmission reached 2.05% to 3.08%.

Table 1. Patient Population

Abbreviation: COPD, chronic obstructive pulmonary disease.

In the bivariate analyses (Table 2), the following factors were positively associated readmission: older age (60-69 years, relative risk [RR] = 1.6; 70-79 years, RR = 2.2; ≥80 years, RR = 3.3; P = .011), dependent functional status (RR = 2.9, P = .008), and anemia (RR = 2.2, P < .001).

Table 2. Bivariate Analysis of Risk Factors for Readmission

Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.

In the multivariate analyses (Table 3), the following factors were independent risk factors for readmission: older age (60-69 years, RR = 1.6; 70-79 years, RR = 2.3; ≥80 years, RR = 3.1; P =.027), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). Interestingly, readmission showed no independent association with diabetes, dyspnea on exertion, BMI, COPD, hypertension, or current smoking status (P > .05 for each).

Table 3. Independent Risk Factors for Readmission on Multivariate Analysis

Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.

Continue to: Table 4...

The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission included pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%) (Table 4).

Table 4. Reasons for Readmission

DISCUSSION

Our analysis of 3042 TSAs from the NSQIP database suggests that unplanned readmission to the hospital occurs following about 1 in 40 cases of TSA. The study also suggests that the most common reasons for readmission encompass pneumonia, dislocation, pulmonary embolism, and surgical site infection. Old age, male sex, anemia, and dependent functional status serve as risk factors for readmission, and patients with such factors should be counseled and monitored accordingly.

In recent years, an increasing emphasis has centered on reducing rates of hospital readmission, with programs such as the Hospital Readmissions Reduction Program of the Affordable Care Act cutting reimbursements for hospitals with high 30-day readmission rates.^17,18 To date, only a few studies have evaluated the reasons for readmission and readmission rates for TSA.^19-23 Initial reports consisted of single-institution TSA registry reviews. For example, Mahoney and colleagues²⁰ retrospectively evaluated shoulder arthroplasty procedures at their institution to document the readmission rates, finding a 5.9% readmission rate at 30 days. Readmission occurred more frequently in the first 30 days following discharge than in the 30- to 90-day period, with the most common reasons for readmission including medical complications, infection, and dislocation. Streubel and colleagues²² evaluated reoperation rates from their institution’s TSA registry, finding a 0.6% reoperation rate for primary TSA at 30 days and 1.5% for revision TSA. Instability and infection were the most common indications for reoperation. Our findings confirm these single-institution results and demonstrate their application to a nationwide sample of TSA, not just to high-volume academic centers. We similarly observed that dislocation, surgical site infection, and medical complications (mostly pneumonia and pulmonary embolism) were common causes of readmission, and that the 30-day readmission rate was about 1 in 40.

Several authors have since used statewide databases to analyze and determine risk factors for readmission following TSA. Lyman and colleagues¹⁹ used the New York State Database to show that higher hospital TSA surgical volume was associated with a lower rate of readmission when age and comorbidities were controlled for in a multivariate model. Old age was also associated with an increased readmission rate in their multivariate analysis, but comorbidities (as measured by the Charlson comorbidity index) presented a nonsignificant associative trend. These authors opted not to determine specific causes of readmission. Schairer and colleagues²¹ used State Inpatient Databases from 7 states, finding a 90-day readmission rate of 7.3%, 82% of which were due to medical complications and 18% of which were due to surgical complications (mostly infection and dislocation). Their multivariate regression revealed that male sex, reverse TSA, Medicaid insurance, patients discharged to inpatient rehabilitation or nursing facilities, medical comorbidities, and low-volume TSA hospitals were associated with readmission. Zhang and colleagues²³ used the same source to show that the 90-day readmission rate reached 14% for surgically treated proximal humerus fractures and higher for patients who underwent open reduction internal fixation, were female, were African American, were discharged to a nursing facility, possessed Medicaid insurance, or experienced medical comorbidities. Most recently, Basques and colleagues³¹ analyzed 1505 TSA cases from 2011 and 2012 in the NSQIP database, finding a 3.3% rate of readmission, with heart disease and hypertension as risk factors for readmission. Although the limitations of the NSQIP database prevented us from analyzing surgeon and hospital TSA volume or reverse vs anatomic TSA, our results confirm that the findings from statewide database studies apply to the United States nationwide NSQIP database. Old patient age, male sex, and medical comorbidities (anemia and dependent functional status) are independent risk factors for TSA readmission. We identified pneumonia, dislocation, pulmonary embolism, and surgical site infection as the most common reasons for readmission.

This study features several limitations that should be considered when interpreting the results. Anatomic and reverse TSA share a CPT code and were not separated using NSQIP data. A number of studies have reported that reverse TSA may place patients at higher risk for readmission;^20,21 however, confounding by other patient factors could play a role in this finding. The 30-day timeframe for readmission is another potential limitation; however, this timeframe is frequently used in other studies and is the relevant timeframe for the reduced reimbursement penalties from the Hospital Readmissions Reduction Program of the Affordable Care Act.¹⁸ Furthermore, the NSQIP database contains no information on surgeon or hospital TSA volume, which is a result of safeguards for patient and provider privacy. Additionally, readmission data were only available for 2011 to 2013, with causes of readmission only present in 2013. Although provided with such current information, we cannot analyze readmission trends over time, such as in response to the Affordable Care Act of 2010. Finally, although NSQIP surgical clinical reviewers strive to identify readmissions to other hospitals during their reviews of outpatient medical records, proportions of these readmissions are possibly missed. Therefore, our 30-day readmission rate may slightly underestimate the true rate.

Despite these limitations, the NSQIP database offers a unique opportunity to examine risk factors and reasons for readmission following TSA. The prior literature on readmission following TSA stemmed either from limited samples or administrative data, which feature known limitations.³² By utilizing a large, prospective, non-administrative, nationwide sample, our findings are probably both more reliable and generalizable to the country as a whole.

CONCLUSION

Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at a higher risk for readmission and should be counseled and monitored accordingly.

This paper will be judged for the Resident Writer’s Award.

Vaccination costs surrounding Japanese encephalitis is high, according to an economic analysis presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

copyright itsmejust/Thinkstock

Vaccination costs surrounding Japanese encephalitis is high, according to an economic analysis presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

copyright itsmejust/Thinkstock

Vaccination costs surrounding Japanese encephalitis is high, according to an economic analysis presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

copyright itsmejust/Thinkstock

AMSTERDAM – Despite some “encouraging signs” seen in a cross-sectional study, it remains difficult to determine whether a patient with systemic lupus erythematosus (SLE) will respond to off-label rituximab therapy, according to David Isenberg, MD.

The presence of constitutional symptoms, which includes fatigue, at baseline were associated with a favorable response to rituximab at 6 months (odds ratio, 7.35; P = .01). Conversely, having more than one anti–extractable nuclear antigen (anti-ENA) antibody was associated with a worse response to rituximab at 12 months (OR, 0.33; P = .032).

“It’s not a cure for lupus, that’s obvious, but used at the appropriate time in the right sort of patients, it can be very helpful,” Dr. Isenberg said in an interview at the European Congress of Rheumatology. That’s both in terms of improving disease activity and reducing the use of glucocorticosteroids and immunosuppressive drugs, he noted.

“The great mystery, as with all drugs, is: Are there any markers which might tell us that the disease is going to do better with rituximab than perhaps with another form of medication, or is it just saying to us, ‘Whatever you do, it doesn’t make much difference’?” Dr. Isenberg said. He discussed the results of a study involving the first 121 patients treated with rituximab at his institution, University College London Hospital (UCLH); he noted this is one of the largest single-center cohorts of individuals with SLE who have used rituximab.

The aim of the study, which was presented at the congress by Hiurma Sánchez Pérez, MD, was therefore to try to find demographic, clinical, and serological markers that might help in predicting the response to rituximab in SLE patients.

Sara Freeman/MDedge News

SOURCE: Sánchez Pérez H and Isenberg D. Ann Rheum Dis. 2018;77(Suppl 2):177. EULAR 2018 Congress, Abstract OP0255.

AMSTERDAM – Despite some “encouraging signs” seen in a cross-sectional study, it remains difficult to determine whether a patient with systemic lupus erythematosus (SLE) will respond to off-label rituximab therapy, according to David Isenberg, MD.

The presence of constitutional symptoms, which includes fatigue, at baseline were associated with a favorable response to rituximab at 6 months (odds ratio, 7.35; P = .01). Conversely, having more than one anti–extractable nuclear antigen (anti-ENA) antibody was associated with a worse response to rituximab at 12 months (OR, 0.33; P = .032).

“It’s not a cure for lupus, that’s obvious, but used at the appropriate time in the right sort of patients, it can be very helpful,” Dr. Isenberg said in an interview at the European Congress of Rheumatology. That’s both in terms of improving disease activity and reducing the use of glucocorticosteroids and immunosuppressive drugs, he noted.

“The great mystery, as with all drugs, is: Are there any markers which might tell us that the disease is going to do better with rituximab than perhaps with another form of medication, or is it just saying to us, ‘Whatever you do, it doesn’t make much difference’?” Dr. Isenberg said. He discussed the results of a study involving the first 121 patients treated with rituximab at his institution, University College London Hospital (UCLH); he noted this is one of the largest single-center cohorts of individuals with SLE who have used rituximab.

The aim of the study, which was presented at the congress by Hiurma Sánchez Pérez, MD, was therefore to try to find demographic, clinical, and serological markers that might help in predicting the response to rituximab in SLE patients.

Sara Freeman/MDedge News

SOURCE: Sánchez Pérez H and Isenberg D. Ann Rheum Dis. 2018;77(Suppl 2):177. EULAR 2018 Congress, Abstract OP0255.

AMSTERDAM – Despite some “encouraging signs” seen in a cross-sectional study, it remains difficult to determine whether a patient with systemic lupus erythematosus (SLE) will respond to off-label rituximab therapy, according to David Isenberg, MD.

The presence of constitutional symptoms, which includes fatigue, at baseline were associated with a favorable response to rituximab at 6 months (odds ratio, 7.35; P = .01). Conversely, having more than one anti–extractable nuclear antigen (anti-ENA) antibody was associated with a worse response to rituximab at 12 months (OR, 0.33; P = .032).

“It’s not a cure for lupus, that’s obvious, but used at the appropriate time in the right sort of patients, it can be very helpful,” Dr. Isenberg said in an interview at the European Congress of Rheumatology. That’s both in terms of improving disease activity and reducing the use of glucocorticosteroids and immunosuppressive drugs, he noted.

“The great mystery, as with all drugs, is: Are there any markers which might tell us that the disease is going to do better with rituximab than perhaps with another form of medication, or is it just saying to us, ‘Whatever you do, it doesn’t make much difference’?” Dr. Isenberg said. He discussed the results of a study involving the first 121 patients treated with rituximab at his institution, University College London Hospital (UCLH); he noted this is one of the largest single-center cohorts of individuals with SLE who have used rituximab.

The aim of the study, which was presented at the congress by Hiurma Sánchez Pérez, MD, was therefore to try to find demographic, clinical, and serological markers that might help in predicting the response to rituximab in SLE patients.

Sara Freeman/MDedge News

SOURCE: Sánchez Pérez H and Isenberg D. Ann Rheum Dis. 2018;77(Suppl 2):177. EULAR 2018 Congress, Abstract OP0255.

Adults who use opioids are more likely to have “complicated health profiles and high levels of involvement in the criminal justice system” compared with adults who do not, according to a retrospective, cross-sectional analysis published July 6 in JAMA Network Open.

“The large proportion of individuals with opioid use disorders who have physical and mental health conditions and who contact the criminal justice system suggests that public health interventions to combat the opioid epidemic ... should coordinate treatment between the criminal justice and health care systems,” wrote Tyler N.A. Winkelman, MD, and his colleagues.

The investigators evaluated a representative sample of responses from 78,976 U.S. adults aged 18-64 who completed the 2015-2016 National Survey on Drug Use and Health, of which 31.3% reported use of prescription opioids, 4.3% reported misuse of opioids, 0.8% reported abuse of prescription opioids, and 0.4% reported heroin use.

The researchers also studied the health characteristics of each individual based on their level of opioid use, whether individuals used other substances in addition to prescription opioids, and the respondents’ recent and distant involvement in the criminal justice system, reported Dr. Winkelman, who is affiliated with the division of general internal medicine at Hennepin Healthcare in Minneapolis, and his colleagues.

After adjustment for health characteristic prevalence and co-occurring substance use across opioid use levels, compared with individuals who reported no opioid use, Dr. Winkelman and his associates found a higher prevalence of mental illness among individuals across four categories: prescription opioid use, prescription opioid misuse, prescription opioid use disorder, and heroin use. They also found a higher prevalence of self-reported chronic conditions such as diabetes, asthma, and high blood pressure across various levels of opioid use, compared with people who reported no opioid use.

Furthermore, Dr. Winkelman and his associates found that as the intensity of opioid use increased, individuals reported an increased prevalence of mild, moderate, and severe mental illness. Individuals who increased their intensity of opioid use also had a greater likelihood of co-occurring substance use with at least one other substance. For example, individuals who misused opioids or used heroin reported that they used tranquilizers or sedatives in more than 50% of cases. Of individuals who reported heroin use, 88.5% said they used prescription opioids within the past year, reported Dr. Winkelman, also a staff physician at the Adult Detention Center in Hennepin County, Minn., and his associates.

The researchers also found 22.4% of individuals (95% confidence interval, 21.7-23.1) who used prescription opioids, 33.2% of individuals who misused prescription opioids (95% CI, 30.9-35.6), 51.7% of individuals with prescription opioid use disorder (95% CI, 45.4-58.0), and 76.8% of individuals with heroin use (95% CI, 70.6-82.1) had any contact with the criminal justice system, compared with 15.9% (95% CI, 15.4-16.4) of individuals who did not report prescription opioid use.

“The overlap we found between involvement in the criminal justice system and opioid use suggests that access to opioid treatment within the criminal justice system is a critical public health issue,” the researchers wrote. They cited studies showing that strategies such as beginning or continuing methadone hydrochloride or buprenorphine hydrochloride during incarceration are tied to a reduction in postrelease mortality.

Among the limitations cited were the National Survey on Drug Use and Health’s cross-sectional design, which makes it difficult to determine whether opioid use preceded involvement in the criminal justice system, or vice versa.

Nevertheless, they said, the study provides the most comprehensive picture to date of the status across several domains of people who use opioids.

“Given the complex health and criminal justice profiles of individuals who use opioids, policy makers should carefully consider how changes to public health insurance programs and sentencing guidelines may aid or hinder a public health approach to the opioid epidemic,” wrote Dr. Winkelman and his colleagues.

Dr. Winkelman disclosed his affiliation with the Hennepin County detention center. Another author disclosed employment with the Colorado Permanente Medical Group and royalties from uptodate.com.

SOURCE: Winkelman TNA et al. JAMA Network Open. 2018 Jul 6. doi: 10.1001/jamanetworkopen.2018.0558.

Adults who use opioids are more likely to have “complicated health profiles and high levels of involvement in the criminal justice system” compared with adults who do not, according to a retrospective, cross-sectional analysis published July 6 in JAMA Network Open.

“The large proportion of individuals with opioid use disorders who have physical and mental health conditions and who contact the criminal justice system suggests that public health interventions to combat the opioid epidemic ... should coordinate treatment between the criminal justice and health care systems,” wrote Tyler N.A. Winkelman, MD, and his colleagues.

The investigators evaluated a representative sample of responses from 78,976 U.S. adults aged 18-64 who completed the 2015-2016 National Survey on Drug Use and Health, of which 31.3% reported use of prescription opioids, 4.3% reported misuse of opioids, 0.8% reported abuse of prescription opioids, and 0.4% reported heroin use.

The researchers also studied the health characteristics of each individual based on their level of opioid use, whether individuals used other substances in addition to prescription opioids, and the respondents’ recent and distant involvement in the criminal justice system, reported Dr. Winkelman, who is affiliated with the division of general internal medicine at Hennepin Healthcare in Minneapolis, and his colleagues.

After adjustment for health characteristic prevalence and co-occurring substance use across opioid use levels, compared with individuals who reported no opioid use, Dr. Winkelman and his associates found a higher prevalence of mental illness among individuals across four categories: prescription opioid use, prescription opioid misuse, prescription opioid use disorder, and heroin use. They also found a higher prevalence of self-reported chronic conditions such as diabetes, asthma, and high blood pressure across various levels of opioid use, compared with people who reported no opioid use.

Furthermore, Dr. Winkelman and his associates found that as the intensity of opioid use increased, individuals reported an increased prevalence of mild, moderate, and severe mental illness. Individuals who increased their intensity of opioid use also had a greater likelihood of co-occurring substance use with at least one other substance. For example, individuals who misused opioids or used heroin reported that they used tranquilizers or sedatives in more than 50% of cases. Of individuals who reported heroin use, 88.5% said they used prescription opioids within the past year, reported Dr. Winkelman, also a staff physician at the Adult Detention Center in Hennepin County, Minn., and his associates.

The researchers also found 22.4% of individuals (95% confidence interval, 21.7-23.1) who used prescription opioids, 33.2% of individuals who misused prescription opioids (95% CI, 30.9-35.6), 51.7% of individuals with prescription opioid use disorder (95% CI, 45.4-58.0), and 76.8% of individuals with heroin use (95% CI, 70.6-82.1) had any contact with the criminal justice system, compared with 15.9% (95% CI, 15.4-16.4) of individuals who did not report prescription opioid use.

“The overlap we found between involvement in the criminal justice system and opioid use suggests that access to opioid treatment within the criminal justice system is a critical public health issue,” the researchers wrote. They cited studies showing that strategies such as beginning or continuing methadone hydrochloride or buprenorphine hydrochloride during incarceration are tied to a reduction in postrelease mortality.

Among the limitations cited were the National Survey on Drug Use and Health’s cross-sectional design, which makes it difficult to determine whether opioid use preceded involvement in the criminal justice system, or vice versa.

Nevertheless, they said, the study provides the most comprehensive picture to date of the status across several domains of people who use opioids.

“Given the complex health and criminal justice profiles of individuals who use opioids, policy makers should carefully consider how changes to public health insurance programs and sentencing guidelines may aid or hinder a public health approach to the opioid epidemic,” wrote Dr. Winkelman and his colleagues.

Dr. Winkelman disclosed his affiliation with the Hennepin County detention center. Another author disclosed employment with the Colorado Permanente Medical Group and royalties from uptodate.com.

SOURCE: Winkelman TNA et al. JAMA Network Open. 2018 Jul 6. doi: 10.1001/jamanetworkopen.2018.0558.

Adults who use opioids are more likely to have “complicated health profiles and high levels of involvement in the criminal justice system” compared with adults who do not, according to a retrospective, cross-sectional analysis published July 6 in JAMA Network Open.

“The large proportion of individuals with opioid use disorders who have physical and mental health conditions and who contact the criminal justice system suggests that public health interventions to combat the opioid epidemic ... should coordinate treatment between the criminal justice and health care systems,” wrote Tyler N.A. Winkelman, MD, and his colleagues.

The investigators evaluated a representative sample of responses from 78,976 U.S. adults aged 18-64 who completed the 2015-2016 National Survey on Drug Use and Health, of which 31.3% reported use of prescription opioids, 4.3% reported misuse of opioids, 0.8% reported abuse of prescription opioids, and 0.4% reported heroin use.

The researchers also studied the health characteristics of each individual based on their level of opioid use, whether individuals used other substances in addition to prescription opioids, and the respondents’ recent and distant involvement in the criminal justice system, reported Dr. Winkelman, who is affiliated with the division of general internal medicine at Hennepin Healthcare in Minneapolis, and his colleagues.

After adjustment for health characteristic prevalence and co-occurring substance use across opioid use levels, compared with individuals who reported no opioid use, Dr. Winkelman and his associates found a higher prevalence of mental illness among individuals across four categories: prescription opioid use, prescription opioid misuse, prescription opioid use disorder, and heroin use. They also found a higher prevalence of self-reported chronic conditions such as diabetes, asthma, and high blood pressure across various levels of opioid use, compared with people who reported no opioid use.

Furthermore, Dr. Winkelman and his associates found that as the intensity of opioid use increased, individuals reported an increased prevalence of mild, moderate, and severe mental illness. Individuals who increased their intensity of opioid use also had a greater likelihood of co-occurring substance use with at least one other substance. For example, individuals who misused opioids or used heroin reported that they used tranquilizers or sedatives in more than 50% of cases. Of individuals who reported heroin use, 88.5% said they used prescription opioids within the past year, reported Dr. Winkelman, also a staff physician at the Adult Detention Center in Hennepin County, Minn., and his associates.

The researchers also found 22.4% of individuals (95% confidence interval, 21.7-23.1) who used prescription opioids, 33.2% of individuals who misused prescription opioids (95% CI, 30.9-35.6), 51.7% of individuals with prescription opioid use disorder (95% CI, 45.4-58.0), and 76.8% of individuals with heroin use (95% CI, 70.6-82.1) had any contact with the criminal justice system, compared with 15.9% (95% CI, 15.4-16.4) of individuals who did not report prescription opioid use.

“The overlap we found between involvement in the criminal justice system and opioid use suggests that access to opioid treatment within the criminal justice system is a critical public health issue,” the researchers wrote. They cited studies showing that strategies such as beginning or continuing methadone hydrochloride or buprenorphine hydrochloride during incarceration are tied to a reduction in postrelease mortality.

Among the limitations cited were the National Survey on Drug Use and Health’s cross-sectional design, which makes it difficult to determine whether opioid use preceded involvement in the criminal justice system, or vice versa.

Nevertheless, they said, the study provides the most comprehensive picture to date of the status across several domains of people who use opioids.

“Given the complex health and criminal justice profiles of individuals who use opioids, policy makers should carefully consider how changes to public health insurance programs and sentencing guidelines may aid or hinder a public health approach to the opioid epidemic,” wrote Dr. Winkelman and his colleagues.

Dr. Winkelman disclosed his affiliation with the Hennepin County detention center. Another author disclosed employment with the Colorado Permanente Medical Group and royalties from uptodate.com.

SOURCE: Winkelman TNA et al. JAMA Network Open. 2018 Jul 6. doi: 10.1001/jamanetworkopen.2018.0558.

ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.

“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”

According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m² or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.

Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.

The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.

Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).

These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.

Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.

“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.

“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”

No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.

[email protected]

SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.
 

ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.

“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”

According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m² or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.

Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.

The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.

Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).

These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.

Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.

“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.

“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”

No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.

[email protected]

SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.
 

ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.

“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”

According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m² or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.

Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.

The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.

Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).

These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.

Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.

“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.

“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”

No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.

[email protected]

SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.