Orthopedics

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

A week earlier I’d had a heart surgery and was heading out for a post-op appointment when I saw it: I had a flat tire. It didn’t make sense. The tire was brand new, and there was no puncture. But it was flat.

I swapped out the flat for the spare and went off base to a tire shop. While I was there, my surgeon’s office called and rescheduled my appointment for a couple of hours later. That was lucky because by the time the tire was fixed, I had just enough time to get there.

The hospital is right near I-35 in San Antonio, Texas. I got off the freeway and onto the access road and paused to turn into the parking lot. That’s when I heard an enormous crash.

I saw a big poof of white smoke, and a car barreled off the freeway and came rolling down the embankment.

When the car hit the access road, I saw a woman ejected through the windshield. She bounced and landed in the road about 25 feet in front of me.

I put my car in park, grabbed my face mask and gloves, and started running toward her. But another vehicle — a truck towing a trailer — came from behind to drive around me. The driver didn’t realize what had happened and couldn’t stop in time…

The trailer ran over her.

I didn’t know if anyone could’ve survived that, but I went to her. I saw several other bystanders, but they were frozen in shock. I was praying, dear God, if she’s alive, let me do whatever I need to do to save her life.

It was a horrible scene. This poor lady was in a bloody heap in the middle of the road. Her right arm was twisted up under her neck so tightly, she was choking herself. So, the first thing I did was straighten her arm out to protect her airway.

I started yelling at people, “Call 9-1-1! Run to the hospital! Let them know there’s an accident out here, and I need help!”

The woman had a pulse, but it was super rapid. On first glance, she clearly had multiple fractures and a bad head bleed. With the sheer number of times she’d been injured, I didn’t know what was going on internally, but it was bad. She was gargling on her own blood and spitting it up. She was drowning.

A couple of technicians from the hospital came and brought me a tiny emergency kit. It had a blood pressure cuff and an oral airway. All the vital signs indicated the lady was going into shock. She’d lost a lot of blood on the pavement.

I was able to get the oral airway in. A few minutes later, a fire chief showed up. By now, the traffic had backed up so badly, the emergency vehicles couldn’t get in. But he managed to get there another way and gave me a cervical collar (C collar) and an Ambu bag.

I was hyper-focused on what I could do at that moment and what I needed to do next. Her stats were going down, but she still had a pulse. If she lost the pulse or went into a lethal rhythm, I’d have to start cardiopulmonary resuscitation (CPR). I asked the other people, but nobody else knew CPR, so I wouldn’t have help.

I could tell the lady had a pelvic fracture, and we needed to stabilize her. I directed people how to hold her neck safely and log-roll her flat on the ground. I also needed to put pressure on the back of her head because of all the bleeding. I got people to give me their clothes and tried to do that as I was bagging her.

The windows of her vehicle had all been blown out. I asked somebody to go find her purse with her ID. Then I noticed something …

My heart jumped into my stomach.

A car seat. There was an empty child’s car seat in the back of the car.

I started yelling at everyone, “Look for a baby! Go up and down the embankment and across the road. There might have been a baby in the car!”

But there wasn’t. Thank God. She hadn’t been driving with her child.

At that point, a paramedic came running from behind all the traffic. We did life support together until the ambulance finally arrived.

Emergency medical services got an intravenous line in and used medical anti-shock trousers. Thankfully, I already had the C collar on, and we’d been bagging her, so they could load her very quickly.

I got rid of my bloody gloves. I told a police officer I would come back. And then I went to my doctor’s appointment.

The window at my doctor’s office faced the access road, so the people there had seen all the traffic. They asked me what happened, and I said, “It was me. I saw it happen. I tried to help.” I was a little frazzled.

When I got back to the scene, the police and the fire chief kept thanking me for stopping. Why wouldn’t I stop? It was astounding to realize that they imagined somebody wouldn’t stop in a situation like this.

They told me the lady was alive. She was in the intensive care unit in critical condition, but she had survived. At that moment, I had this overwhelming feeling: God had put me in this exact place at the exact time to save her life.

Looking back, I think about how God ordered my steps. Without the mysterious flat tire, I would’ve gone to the hospital earlier. If my appointment hadn’t been rescheduled, I wouldn’t have been on the access road. All those events brought me there.

Several months later, the woman’s family contacted me and asked if we could meet. I found out more about her injuries. She’d had multiple skull fractures, facial fractures, and a broken jaw. Her upper arm was broken in three places. Her clavicle was broken. She had internal bleeding, a pelvic fracture, and a broken leg. She was 28 years old.

She’d had multiple surgeries, spent 2 months in the ICU, and another 3 months in intensive rehab. But she survived. It was incredible.

We all met up at a McDonald’s. First, her little son — who was the baby I thought might have been in the car — ran up to me and said, “Thank you for saving my mommy’s life.”

Then I turned, and there she was — a beautiful lady looking at me with awe and crying, saying, “It’s me.”

She obviously had gone through a transformation from all the injuries and the medications. She had a little bit of a speech delay, but mentally, she was there. She could walk.

She said, “You’re my angel. God put you there to save my life.” Her family all came up and hugged me. It was so beautiful.

She told me about the accident. She’d been speeding that day, zigzagging through lanes to get around the traffic. And she didn’t have her seatbelt on. She’d driven onto the shoulder to try to pass everyone, but it started narrowing. She clipped somebody’s bumper, went into a tailspin, and collided with a second vehicle, which caused her to flip over and down the embankment.

“God’s given me a new lease on life,” she said, “a fresh start. I will forever wear my seatbelt. And I’m going to do whatever I can to give back to other people because I don’t even feel like I deserve this.”

I just cried.

I’ve been a nurse for 29 years, first on the civilian side and later in the military. I’ve led codes and responded to trauma in a hospital setting or a deployed environment. I was well prepared to do what I did. But doing it under such stress with adrenaline bombarding me ... I’m amazed. I just think God’s hand was on me.

At that time, I was personally going through some things. After my heart surgery, I was in an emotional place where I didn’t feel loved or valued. But when I had that realization — when I knew that I was meant to be there to save her life, I also got the very clear message that I was valued and loved so much.

I know I have a very strong purpose. That day changed my life.
 

US Air Force Lt. Col. Anne Staley is the officer in charge of the Military Training Network, a division of the Defense Health Agency Education and Training Directorate in San Antonio, Texas.

A version of this article appeared on Medscape.com.

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

A week earlier I’d had a heart surgery and was heading out for a post-op appointment when I saw it: I had a flat tire. It didn’t make sense. The tire was brand new, and there was no puncture. But it was flat.

I swapped out the flat for the spare and went off base to a tire shop. While I was there, my surgeon’s office called and rescheduled my appointment for a couple of hours later. That was lucky because by the time the tire was fixed, I had just enough time to get there.

The hospital is right near I-35 in San Antonio, Texas. I got off the freeway and onto the access road and paused to turn into the parking lot. That’s when I heard an enormous crash.

I saw a big poof of white smoke, and a car barreled off the freeway and came rolling down the embankment.

When the car hit the access road, I saw a woman ejected through the windshield. She bounced and landed in the road about 25 feet in front of me.

I put my car in park, grabbed my face mask and gloves, and started running toward her. But another vehicle — a truck towing a trailer — came from behind to drive around me. The driver didn’t realize what had happened and couldn’t stop in time…

The trailer ran over her.

I didn’t know if anyone could’ve survived that, but I went to her. I saw several other bystanders, but they were frozen in shock. I was praying, dear God, if she’s alive, let me do whatever I need to do to save her life.

It was a horrible scene. This poor lady was in a bloody heap in the middle of the road. Her right arm was twisted up under her neck so tightly, she was choking herself. So, the first thing I did was straighten her arm out to protect her airway.

I started yelling at people, “Call 9-1-1! Run to the hospital! Let them know there’s an accident out here, and I need help!”

The woman had a pulse, but it was super rapid. On first glance, she clearly had multiple fractures and a bad head bleed. With the sheer number of times she’d been injured, I didn’t know what was going on internally, but it was bad. She was gargling on her own blood and spitting it up. She was drowning.

A couple of technicians from the hospital came and brought me a tiny emergency kit. It had a blood pressure cuff and an oral airway. All the vital signs indicated the lady was going into shock. She’d lost a lot of blood on the pavement.

I was able to get the oral airway in. A few minutes later, a fire chief showed up. By now, the traffic had backed up so badly, the emergency vehicles couldn’t get in. But he managed to get there another way and gave me a cervical collar (C collar) and an Ambu bag.

I was hyper-focused on what I could do at that moment and what I needed to do next. Her stats were going down, but she still had a pulse. If she lost the pulse or went into a lethal rhythm, I’d have to start cardiopulmonary resuscitation (CPR). I asked the other people, but nobody else knew CPR, so I wouldn’t have help.

I could tell the lady had a pelvic fracture, and we needed to stabilize her. I directed people how to hold her neck safely and log-roll her flat on the ground. I also needed to put pressure on the back of her head because of all the bleeding. I got people to give me their clothes and tried to do that as I was bagging her.

The windows of her vehicle had all been blown out. I asked somebody to go find her purse with her ID. Then I noticed something …

My heart jumped into my stomach.

A car seat. There was an empty child’s car seat in the back of the car.

I started yelling at everyone, “Look for a baby! Go up and down the embankment and across the road. There might have been a baby in the car!”

But there wasn’t. Thank God. She hadn’t been driving with her child.

At that point, a paramedic came running from behind all the traffic. We did life support together until the ambulance finally arrived.

Emergency medical services got an intravenous line in and used medical anti-shock trousers. Thankfully, I already had the C collar on, and we’d been bagging her, so they could load her very quickly.

I got rid of my bloody gloves. I told a police officer I would come back. And then I went to my doctor’s appointment.

The window at my doctor’s office faced the access road, so the people there had seen all the traffic. They asked me what happened, and I said, “It was me. I saw it happen. I tried to help.” I was a little frazzled.

When I got back to the scene, the police and the fire chief kept thanking me for stopping. Why wouldn’t I stop? It was astounding to realize that they imagined somebody wouldn’t stop in a situation like this.

They told me the lady was alive. She was in the intensive care unit in critical condition, but she had survived. At that moment, I had this overwhelming feeling: God had put me in this exact place at the exact time to save her life.

Looking back, I think about how God ordered my steps. Without the mysterious flat tire, I would’ve gone to the hospital earlier. If my appointment hadn’t been rescheduled, I wouldn’t have been on the access road. All those events brought me there.

Several months later, the woman’s family contacted me and asked if we could meet. I found out more about her injuries. She’d had multiple skull fractures, facial fractures, and a broken jaw. Her upper arm was broken in three places. Her clavicle was broken. She had internal bleeding, a pelvic fracture, and a broken leg. She was 28 years old.

She’d had multiple surgeries, spent 2 months in the ICU, and another 3 months in intensive rehab. But she survived. It was incredible.

We all met up at a McDonald’s. First, her little son — who was the baby I thought might have been in the car — ran up to me and said, “Thank you for saving my mommy’s life.”

Then I turned, and there she was — a beautiful lady looking at me with awe and crying, saying, “It’s me.”

She obviously had gone through a transformation from all the injuries and the medications. She had a little bit of a speech delay, but mentally, she was there. She could walk.

She said, “You’re my angel. God put you there to save my life.” Her family all came up and hugged me. It was so beautiful.

She told me about the accident. She’d been speeding that day, zigzagging through lanes to get around the traffic. And she didn’t have her seatbelt on. She’d driven onto the shoulder to try to pass everyone, but it started narrowing. She clipped somebody’s bumper, went into a tailspin, and collided with a second vehicle, which caused her to flip over and down the embankment.

“God’s given me a new lease on life,” she said, “a fresh start. I will forever wear my seatbelt. And I’m going to do whatever I can to give back to other people because I don’t even feel like I deserve this.”

I just cried.

I’ve been a nurse for 29 years, first on the civilian side and later in the military. I’ve led codes and responded to trauma in a hospital setting or a deployed environment. I was well prepared to do what I did. But doing it under such stress with adrenaline bombarding me ... I’m amazed. I just think God’s hand was on me.

At that time, I was personally going through some things. After my heart surgery, I was in an emotional place where I didn’t feel loved or valued. But when I had that realization — when I knew that I was meant to be there to save her life, I also got the very clear message that I was valued and loved so much.

I know I have a very strong purpose. That day changed my life.
 

US Air Force Lt. Col. Anne Staley is the officer in charge of the Military Training Network, a division of the Defense Health Agency Education and Training Directorate in San Antonio, Texas.

A version of this article appeared on Medscape.com.

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

A week earlier I’d had a heart surgery and was heading out for a post-op appointment when I saw it: I had a flat tire. It didn’t make sense. The tire was brand new, and there was no puncture. But it was flat.

I swapped out the flat for the spare and went off base to a tire shop. While I was there, my surgeon’s office called and rescheduled my appointment for a couple of hours later. That was lucky because by the time the tire was fixed, I had just enough time to get there.

The hospital is right near I-35 in San Antonio, Texas. I got off the freeway and onto the access road and paused to turn into the parking lot. That’s when I heard an enormous crash.

I saw a big poof of white smoke, and a car barreled off the freeway and came rolling down the embankment.

When the car hit the access road, I saw a woman ejected through the windshield. She bounced and landed in the road about 25 feet in front of me.

I put my car in park, grabbed my face mask and gloves, and started running toward her. But another vehicle — a truck towing a trailer — came from behind to drive around me. The driver didn’t realize what had happened and couldn’t stop in time…

The trailer ran over her.

I didn’t know if anyone could’ve survived that, but I went to her. I saw several other bystanders, but they were frozen in shock. I was praying, dear God, if she’s alive, let me do whatever I need to do to save her life.

It was a horrible scene. This poor lady was in a bloody heap in the middle of the road. Her right arm was twisted up under her neck so tightly, she was choking herself. So, the first thing I did was straighten her arm out to protect her airway.

I started yelling at people, “Call 9-1-1! Run to the hospital! Let them know there’s an accident out here, and I need help!”

The woman had a pulse, but it was super rapid. On first glance, she clearly had multiple fractures and a bad head bleed. With the sheer number of times she’d been injured, I didn’t know what was going on internally, but it was bad. She was gargling on her own blood and spitting it up. She was drowning.

A couple of technicians from the hospital came and brought me a tiny emergency kit. It had a blood pressure cuff and an oral airway. All the vital signs indicated the lady was going into shock. She’d lost a lot of blood on the pavement.

I was able to get the oral airway in. A few minutes later, a fire chief showed up. By now, the traffic had backed up so badly, the emergency vehicles couldn’t get in. But he managed to get there another way and gave me a cervical collar (C collar) and an Ambu bag.

I was hyper-focused on what I could do at that moment and what I needed to do next. Her stats were going down, but she still had a pulse. If she lost the pulse or went into a lethal rhythm, I’d have to start cardiopulmonary resuscitation (CPR). I asked the other people, but nobody else knew CPR, so I wouldn’t have help.

I could tell the lady had a pelvic fracture, and we needed to stabilize her. I directed people how to hold her neck safely and log-roll her flat on the ground. I also needed to put pressure on the back of her head because of all the bleeding. I got people to give me their clothes and tried to do that as I was bagging her.

The windows of her vehicle had all been blown out. I asked somebody to go find her purse with her ID. Then I noticed something …

My heart jumped into my stomach.

A car seat. There was an empty child’s car seat in the back of the car.

I started yelling at everyone, “Look for a baby! Go up and down the embankment and across the road. There might have been a baby in the car!”

But there wasn’t. Thank God. She hadn’t been driving with her child.

At that point, a paramedic came running from behind all the traffic. We did life support together until the ambulance finally arrived.

Emergency medical services got an intravenous line in and used medical anti-shock trousers. Thankfully, I already had the C collar on, and we’d been bagging her, so they could load her very quickly.

I got rid of my bloody gloves. I told a police officer I would come back. And then I went to my doctor’s appointment.

The window at my doctor’s office faced the access road, so the people there had seen all the traffic. They asked me what happened, and I said, “It was me. I saw it happen. I tried to help.” I was a little frazzled.

When I got back to the scene, the police and the fire chief kept thanking me for stopping. Why wouldn’t I stop? It was astounding to realize that they imagined somebody wouldn’t stop in a situation like this.

They told me the lady was alive. She was in the intensive care unit in critical condition, but she had survived. At that moment, I had this overwhelming feeling: God had put me in this exact place at the exact time to save her life.

Looking back, I think about how God ordered my steps. Without the mysterious flat tire, I would’ve gone to the hospital earlier. If my appointment hadn’t been rescheduled, I wouldn’t have been on the access road. All those events brought me there.

Several months later, the woman’s family contacted me and asked if we could meet. I found out more about her injuries. She’d had multiple skull fractures, facial fractures, and a broken jaw. Her upper arm was broken in three places. Her clavicle was broken. She had internal bleeding, a pelvic fracture, and a broken leg. She was 28 years old.

She’d had multiple surgeries, spent 2 months in the ICU, and another 3 months in intensive rehab. But she survived. It was incredible.

We all met up at a McDonald’s. First, her little son — who was the baby I thought might have been in the car — ran up to me and said, “Thank you for saving my mommy’s life.”

Then I turned, and there she was — a beautiful lady looking at me with awe and crying, saying, “It’s me.”

She obviously had gone through a transformation from all the injuries and the medications. She had a little bit of a speech delay, but mentally, she was there. She could walk.

She said, “You’re my angel. God put you there to save my life.” Her family all came up and hugged me. It was so beautiful.

She told me about the accident. She’d been speeding that day, zigzagging through lanes to get around the traffic. And she didn’t have her seatbelt on. She’d driven onto the shoulder to try to pass everyone, but it started narrowing. She clipped somebody’s bumper, went into a tailspin, and collided with a second vehicle, which caused her to flip over and down the embankment.

“God’s given me a new lease on life,” she said, “a fresh start. I will forever wear my seatbelt. And I’m going to do whatever I can to give back to other people because I don’t even feel like I deserve this.”

I just cried.

I’ve been a nurse for 29 years, first on the civilian side and later in the military. I’ve led codes and responded to trauma in a hospital setting or a deployed environment. I was well prepared to do what I did. But doing it under such stress with adrenaline bombarding me ... I’m amazed. I just think God’s hand was on me.

At that time, I was personally going through some things. After my heart surgery, I was in an emotional place where I didn’t feel loved or valued. But when I had that realization — when I knew that I was meant to be there to save her life, I also got the very clear message that I was valued and loved so much.

I know I have a very strong purpose. That day changed my life.
 

US Air Force Lt. Col. Anne Staley is the officer in charge of the Military Training Network, a division of the Defense Health Agency Education and Training Directorate in San Antonio, Texas.

A version of this article appeared on Medscape.com.

Non–Lyme disease, tick-borne illnesses — such as spotted fever group rickettsiosis (SFGR), ehrlichiosis, and alpha-gal syndrome (AGS) — are emerging public health threats, but whether prior tick exposures are responsible for long-term complications, such as musculoskeletal symptoms or osteoarthritis, has been unclear.

Many patients attribute their nonspecific long-term symptoms, such as musculoskeletal pain, to previous illnesses from tick bites, note authors of a study published in JAMA Network Open. But the researchers, led by Diana L. Zychowski, MD, MPH, with the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, found that Ehrlichia or Rickettsia seropositivity was not associated with chronic musculoskeletal symptoms, though they write that “further investigation into the pathogenesis of [alpha-gal] syndrome is needed.”
 

Tick-Borne Illness Cases Multiplying

Cases of tick-borne illness (TBD) in the United States have multiplied in recent years. More than 50,000 cases of TBD in the United States were reported in 2019, which doubled the number of cases over the previous 2 decades, the authors note.

Most of the cases are Lyme disease, but others — including SFGR and ehrlichiosis — represent an important public health threat, especially in southeastern states, the authors write. Cases of ehrlichiosis, for example, transmitted by the lone star tick, soared more than 10-fold since 2000.

The goal of this study was to evaluate whether there was an association between prior exposure to TBDs endemic to the southeastern United States and chronic musculoskeletal symptoms and radiographic measures of osteoarthritis.

Researchers analyzed 488 blood samples from the fourth visit (2017-2018) of the Johnston County Osteoarthritis (JoCo OA) project, an ongoing population-based study in Johnston County, North Carolina. JoCo OA participants include noninstitutionalized White and Black Johnston County residents 45 years old or older with osteoarthritis.

They measured seroprevalence of Rickettsia- and Ehrlichia-specific immunoglobulin G (IgG) as well as alpha-gal immunoglobulin E (IgE) in patient samples. Only alpha-gal IgE was linked in the study with knee pain, aching, or stiffness. Antibodies to Rickettsia, Ehrlichia, and alpha-gal were not associated with radiographic, symptomatic knee osteoarthritis.

“To our knowledge,” the authors write, “this study was the first population-based seroprevalence study of SFGR, Ehrlichia, and [alpha]-gal.”

The study also found a high prevalence of TBD exposure in the cohort. More than a third (36.5%) had either an alpha-gal IgE level greater than 0.1 IU/mL, a positive test for SFGR IgG antibodies, or a positive test for Ehrlichia IgG antibodies.

Given that not every tick carries an infectious pathogen, the findings show human-tick interactions are common, they write.

“These findings suggest that substantial investment is required to examine the pathogenesis of these TBDs and interventions to reduce human-tick interactions,” the authors conclude.

This study was funded by a Creativity Hub Award from the University of North Carolina Office of the Vice Chancellor for Research. The JoCo OA project is supported in part by grants from the Association of Schools of Public Health/Centers for Disease Control and Prevention (CDC); and grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Authors reported grants from the National Institutes of Health, the CDC, and several pharmaceutical companies.

Non–Lyme disease, tick-borne illnesses — such as spotted fever group rickettsiosis (SFGR), ehrlichiosis, and alpha-gal syndrome (AGS) — are emerging public health threats, but whether prior tick exposures are responsible for long-term complications, such as musculoskeletal symptoms or osteoarthritis, has been unclear.

Many patients attribute their nonspecific long-term symptoms, such as musculoskeletal pain, to previous illnesses from tick bites, note authors of a study published in JAMA Network Open. But the researchers, led by Diana L. Zychowski, MD, MPH, with the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, found that Ehrlichia or Rickettsia seropositivity was not associated with chronic musculoskeletal symptoms, though they write that “further investigation into the pathogenesis of [alpha-gal] syndrome is needed.”
 

Tick-Borne Illness Cases Multiplying

Cases of tick-borne illness (TBD) in the United States have multiplied in recent years. More than 50,000 cases of TBD in the United States were reported in 2019, which doubled the number of cases over the previous 2 decades, the authors note.

Most of the cases are Lyme disease, but others — including SFGR and ehrlichiosis — represent an important public health threat, especially in southeastern states, the authors write. Cases of ehrlichiosis, for example, transmitted by the lone star tick, soared more than 10-fold since 2000.

The goal of this study was to evaluate whether there was an association between prior exposure to TBDs endemic to the southeastern United States and chronic musculoskeletal symptoms and radiographic measures of osteoarthritis.

Researchers analyzed 488 blood samples from the fourth visit (2017-2018) of the Johnston County Osteoarthritis (JoCo OA) project, an ongoing population-based study in Johnston County, North Carolina. JoCo OA participants include noninstitutionalized White and Black Johnston County residents 45 years old or older with osteoarthritis.

They measured seroprevalence of Rickettsia- and Ehrlichia-specific immunoglobulin G (IgG) as well as alpha-gal immunoglobulin E (IgE) in patient samples. Only alpha-gal IgE was linked in the study with knee pain, aching, or stiffness. Antibodies to Rickettsia, Ehrlichia, and alpha-gal were not associated with radiographic, symptomatic knee osteoarthritis.

“To our knowledge,” the authors write, “this study was the first population-based seroprevalence study of SFGR, Ehrlichia, and [alpha]-gal.”

The study also found a high prevalence of TBD exposure in the cohort. More than a third (36.5%) had either an alpha-gal IgE level greater than 0.1 IU/mL, a positive test for SFGR IgG antibodies, or a positive test for Ehrlichia IgG antibodies.

Given that not every tick carries an infectious pathogen, the findings show human-tick interactions are common, they write.

“These findings suggest that substantial investment is required to examine the pathogenesis of these TBDs and interventions to reduce human-tick interactions,” the authors conclude.

This study was funded by a Creativity Hub Award from the University of North Carolina Office of the Vice Chancellor for Research. The JoCo OA project is supported in part by grants from the Association of Schools of Public Health/Centers for Disease Control and Prevention (CDC); and grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Authors reported grants from the National Institutes of Health, the CDC, and several pharmaceutical companies.

Non–Lyme disease, tick-borne illnesses — such as spotted fever group rickettsiosis (SFGR), ehrlichiosis, and alpha-gal syndrome (AGS) — are emerging public health threats, but whether prior tick exposures are responsible for long-term complications, such as musculoskeletal symptoms or osteoarthritis, has been unclear.

Many patients attribute their nonspecific long-term symptoms, such as musculoskeletal pain, to previous illnesses from tick bites, note authors of a study published in JAMA Network Open. But the researchers, led by Diana L. Zychowski, MD, MPH, with the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, found that Ehrlichia or Rickettsia seropositivity was not associated with chronic musculoskeletal symptoms, though they write that “further investigation into the pathogenesis of [alpha-gal] syndrome is needed.”
 

Tick-Borne Illness Cases Multiplying

Cases of tick-borne illness (TBD) in the United States have multiplied in recent years. More than 50,000 cases of TBD in the United States were reported in 2019, which doubled the number of cases over the previous 2 decades, the authors note.

Most of the cases are Lyme disease, but others — including SFGR and ehrlichiosis — represent an important public health threat, especially in southeastern states, the authors write. Cases of ehrlichiosis, for example, transmitted by the lone star tick, soared more than 10-fold since 2000.

The goal of this study was to evaluate whether there was an association between prior exposure to TBDs endemic to the southeastern United States and chronic musculoskeletal symptoms and radiographic measures of osteoarthritis.

Researchers analyzed 488 blood samples from the fourth visit (2017-2018) of the Johnston County Osteoarthritis (JoCo OA) project, an ongoing population-based study in Johnston County, North Carolina. JoCo OA participants include noninstitutionalized White and Black Johnston County residents 45 years old or older with osteoarthritis.

They measured seroprevalence of Rickettsia- and Ehrlichia-specific immunoglobulin G (IgG) as well as alpha-gal immunoglobulin E (IgE) in patient samples. Only alpha-gal IgE was linked in the study with knee pain, aching, or stiffness. Antibodies to Rickettsia, Ehrlichia, and alpha-gal were not associated with radiographic, symptomatic knee osteoarthritis.

“To our knowledge,” the authors write, “this study was the first population-based seroprevalence study of SFGR, Ehrlichia, and [alpha]-gal.”

The study also found a high prevalence of TBD exposure in the cohort. More than a third (36.5%) had either an alpha-gal IgE level greater than 0.1 IU/mL, a positive test for SFGR IgG antibodies, or a positive test for Ehrlichia IgG antibodies.

Given that not every tick carries an infectious pathogen, the findings show human-tick interactions are common, they write.

“These findings suggest that substantial investment is required to examine the pathogenesis of these TBDs and interventions to reduce human-tick interactions,” the authors conclude.

This study was funded by a Creativity Hub Award from the University of North Carolina Office of the Vice Chancellor for Research. The JoCo OA project is supported in part by grants from the Association of Schools of Public Health/Centers for Disease Control and Prevention (CDC); and grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Authors reported grants from the National Institutes of Health, the CDC, and several pharmaceutical companies.

A meta-analysis appears to allay concerns that surgeons might be performing total knee arthroplasties (TKA) on healthier patients.

“Both the total number [of surgeons performing primary TKA] and the number of surgeons per capita have been generally increasing,” wrote Peter Dust, MD, of McGill University, Montreal, and coauthors. “Reassuringly, however, our results suggest that despite the increasing number of surgeons, the indications for surgery are not being eroded by operating on healthier patients to fill operating room time.”

The study was published in the Canadian Journal of Surgery.
 

Rising demand

In the paper, Dr. Dust and colleagues noted that there was a 162% increase in volume of total knee arthroplasties among people enrolled in the Medicare program between 1991 and 2010.

Unrelated to the study, the Canadian Institute for Health Information (CIHI) has reported similar trends. In 2018-2019, about 75,000 knee replacements were performed in Canada; an increase of 22.5% over the previous 5 years. The numbers dropped in 2020-2021 during the pandemic because of limited access to medical facilities during that time, but then rebounded between April and September 2022 to close to prepandemic numbers. However, about 50% of patients were waiting longer during that time than the recommended 6 months (182 days) for their surgery.
 

So, what’s happening?

The trends for rising numbers of knee surgeries cannot be fully explained by population growth and increasing rates of obesity, Dr. Dust and colleagues wrote. That led them to ask whether some patients were undergoing surgery with a higher level of preoperative function compared with the past.

They conducted a systematic review and meta-analysis of the MEDLINE, Embase, and Cochrane databases with the aim of determining the effect of time, age, and sex on preoperative functional status. A total of 149 studies were ultimately included in the study, with data from 257 independent groups and 57,844 patients recruited from 1991 to 2015.

The analysis revealed that patients are undergoing TKA with a level of preoperative function similar to that in the past. Also, patient age, sex, and location did not influence the functional status at which patients were considered for surgery.

Jasvinder Singh, MD, professor of medicine and epidemiology at University of Alabama at Birmingham, who was not involved with the research, offered another suggestion to explain the trend: People today are more familiar with knee replacement surgery and thus find it a less daunting option.

“Everybody knows somebody who has had a knee done or a hip done,” Singh said in an interview.”People are a lot more familiar with these things than they were 30 years ago.”
 

Subjective criteria persists

In the paper, Dr. Dust said that he and his colleagues had hoped this study might reveal a target physical component summary (PCS) score, used to assess functional status, based on which patients could be considered for surgery. Their findings, however, did not enable such a recommendation to be made.

In an interview, Claudette M. Lajam, MD, a spokesperson for the American Academy of Orthopedic Surgeons (AAOS), agreed that there does not appear to be a trend toward earlier intervention. Also, a precise number or score that can be used to determine when patients should undergo TKA still does not exist. Dr. Lajam is professor of orthopedic surgery and system chief for orthopedic quality and risk at NYU Langone Health, New York.

The “sweet spot time” for TKA is still not clear based on available metrics, Dr. Lajam said. Physicians need to consider not only patient level of function before surgery, but also when to intervene so they will get the most benefit from these procedures.

The knee has to be “bad enough to justify major surgery,” she said, while waiting too long might lead to inferior outcomes.

In time, she thinks artificial intelligence (AI) could help in identifying when primary care clinicians should advise patients to seek specialist care for ailing knees.

AI could allow physicians and researchers to search for clues about the best timing for surgery by combing through millions of x-rays, a variety of functional scores used in assessing patients, and other sources of information, she explained. At this time, the PCS used by Dr. Dust and colleagues is just one of many measures used to assess patient level of function. AI might be able to bring these data together for scientists to review.

“AI can see patterns that I can’t see right now,” Dr. Lajam said.

But she emphasized that any AI application would be an aid to physicians in counseling patients. Evaluation by an experienced surgeon, together with guidance from any AI tool, could provide a greater understanding of how TKA could help patients with arthritis of the knee.

“The physician sees intangibles that AI would not see because we actually talk to the patient,” she explained.

Dr. Dust said there was no outside funding for the study and the authors and Dr. Lajam reported no relevant financial relationships. Dr. Singh said he has received consulting fees from AstraZeneca and institutional research support from Zimmer Biomet Holdings. He has received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America, and owns stock options in Atai Life Sciences. He is a member of the executive committee of Outcome Measures in Rheumatology (OMERACT), an organization that receives arms-length funding from eight companies.

A version of this article appeared on Medscape.com.

A meta-analysis appears to allay concerns that surgeons might be performing total knee arthroplasties (TKA) on healthier patients.

“Both the total number [of surgeons performing primary TKA] and the number of surgeons per capita have been generally increasing,” wrote Peter Dust, MD, of McGill University, Montreal, and coauthors. “Reassuringly, however, our results suggest that despite the increasing number of surgeons, the indications for surgery are not being eroded by operating on healthier patients to fill operating room time.”

The study was published in the Canadian Journal of Surgery.
 

Rising demand

In the paper, Dr. Dust and colleagues noted that there was a 162% increase in volume of total knee arthroplasties among people enrolled in the Medicare program between 1991 and 2010.

Unrelated to the study, the Canadian Institute for Health Information (CIHI) has reported similar trends. In 2018-2019, about 75,000 knee replacements were performed in Canada; an increase of 22.5% over the previous 5 years. The numbers dropped in 2020-2021 during the pandemic because of limited access to medical facilities during that time, but then rebounded between April and September 2022 to close to prepandemic numbers. However, about 50% of patients were waiting longer during that time than the recommended 6 months (182 days) for their surgery.
 

So, what’s happening?

The trends for rising numbers of knee surgeries cannot be fully explained by population growth and increasing rates of obesity, Dr. Dust and colleagues wrote. That led them to ask whether some patients were undergoing surgery with a higher level of preoperative function compared with the past.

They conducted a systematic review and meta-analysis of the MEDLINE, Embase, and Cochrane databases with the aim of determining the effect of time, age, and sex on preoperative functional status. A total of 149 studies were ultimately included in the study, with data from 257 independent groups and 57,844 patients recruited from 1991 to 2015.

The analysis revealed that patients are undergoing TKA with a level of preoperative function similar to that in the past. Also, patient age, sex, and location did not influence the functional status at which patients were considered for surgery.

Jasvinder Singh, MD, professor of medicine and epidemiology at University of Alabama at Birmingham, who was not involved with the research, offered another suggestion to explain the trend: People today are more familiar with knee replacement surgery and thus find it a less daunting option.

“Everybody knows somebody who has had a knee done or a hip done,” Singh said in an interview.”People are a lot more familiar with these things than they were 30 years ago.”
 

Subjective criteria persists

In the paper, Dr. Dust said that he and his colleagues had hoped this study might reveal a target physical component summary (PCS) score, used to assess functional status, based on which patients could be considered for surgery. Their findings, however, did not enable such a recommendation to be made.

In an interview, Claudette M. Lajam, MD, a spokesperson for the American Academy of Orthopedic Surgeons (AAOS), agreed that there does not appear to be a trend toward earlier intervention. Also, a precise number or score that can be used to determine when patients should undergo TKA still does not exist. Dr. Lajam is professor of orthopedic surgery and system chief for orthopedic quality and risk at NYU Langone Health, New York.

The “sweet spot time” for TKA is still not clear based on available metrics, Dr. Lajam said. Physicians need to consider not only patient level of function before surgery, but also when to intervene so they will get the most benefit from these procedures.

The knee has to be “bad enough to justify major surgery,” she said, while waiting too long might lead to inferior outcomes.

In time, she thinks artificial intelligence (AI) could help in identifying when primary care clinicians should advise patients to seek specialist care for ailing knees.

AI could allow physicians and researchers to search for clues about the best timing for surgery by combing through millions of x-rays, a variety of functional scores used in assessing patients, and other sources of information, she explained. At this time, the PCS used by Dr. Dust and colleagues is just one of many measures used to assess patient level of function. AI might be able to bring these data together for scientists to review.

“AI can see patterns that I can’t see right now,” Dr. Lajam said.

But she emphasized that any AI application would be an aid to physicians in counseling patients. Evaluation by an experienced surgeon, together with guidance from any AI tool, could provide a greater understanding of how TKA could help patients with arthritis of the knee.

“The physician sees intangibles that AI would not see because we actually talk to the patient,” she explained.

Dr. Dust said there was no outside funding for the study and the authors and Dr. Lajam reported no relevant financial relationships. Dr. Singh said he has received consulting fees from AstraZeneca and institutional research support from Zimmer Biomet Holdings. He has received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America, and owns stock options in Atai Life Sciences. He is a member of the executive committee of Outcome Measures in Rheumatology (OMERACT), an organization that receives arms-length funding from eight companies.

A version of this article appeared on Medscape.com.

A meta-analysis appears to allay concerns that surgeons might be performing total knee arthroplasties (TKA) on healthier patients.

“Both the total number [of surgeons performing primary TKA] and the number of surgeons per capita have been generally increasing,” wrote Peter Dust, MD, of McGill University, Montreal, and coauthors. “Reassuringly, however, our results suggest that despite the increasing number of surgeons, the indications for surgery are not being eroded by operating on healthier patients to fill operating room time.”

The study was published in the Canadian Journal of Surgery.
 

Rising demand

In the paper, Dr. Dust and colleagues noted that there was a 162% increase in volume of total knee arthroplasties among people enrolled in the Medicare program between 1991 and 2010.

Unrelated to the study, the Canadian Institute for Health Information (CIHI) has reported similar trends. In 2018-2019, about 75,000 knee replacements were performed in Canada; an increase of 22.5% over the previous 5 years. The numbers dropped in 2020-2021 during the pandemic because of limited access to medical facilities during that time, but then rebounded between April and September 2022 to close to prepandemic numbers. However, about 50% of patients were waiting longer during that time than the recommended 6 months (182 days) for their surgery.
 

So, what’s happening?

The trends for rising numbers of knee surgeries cannot be fully explained by population growth and increasing rates of obesity, Dr. Dust and colleagues wrote. That led them to ask whether some patients were undergoing surgery with a higher level of preoperative function compared with the past.

They conducted a systematic review and meta-analysis of the MEDLINE, Embase, and Cochrane databases with the aim of determining the effect of time, age, and sex on preoperative functional status. A total of 149 studies were ultimately included in the study, with data from 257 independent groups and 57,844 patients recruited from 1991 to 2015.

The analysis revealed that patients are undergoing TKA with a level of preoperative function similar to that in the past. Also, patient age, sex, and location did not influence the functional status at which patients were considered for surgery.

Jasvinder Singh, MD, professor of medicine and epidemiology at University of Alabama at Birmingham, who was not involved with the research, offered another suggestion to explain the trend: People today are more familiar with knee replacement surgery and thus find it a less daunting option.

“Everybody knows somebody who has had a knee done or a hip done,” Singh said in an interview.”People are a lot more familiar with these things than they were 30 years ago.”
 

Subjective criteria persists

In the paper, Dr. Dust said that he and his colleagues had hoped this study might reveal a target physical component summary (PCS) score, used to assess functional status, based on which patients could be considered for surgery. Their findings, however, did not enable such a recommendation to be made.

In an interview, Claudette M. Lajam, MD, a spokesperson for the American Academy of Orthopedic Surgeons (AAOS), agreed that there does not appear to be a trend toward earlier intervention. Also, a precise number or score that can be used to determine when patients should undergo TKA still does not exist. Dr. Lajam is professor of orthopedic surgery and system chief for orthopedic quality and risk at NYU Langone Health, New York.

The “sweet spot time” for TKA is still not clear based on available metrics, Dr. Lajam said. Physicians need to consider not only patient level of function before surgery, but also when to intervene so they will get the most benefit from these procedures.

The knee has to be “bad enough to justify major surgery,” she said, while waiting too long might lead to inferior outcomes.

In time, she thinks artificial intelligence (AI) could help in identifying when primary care clinicians should advise patients to seek specialist care for ailing knees.

AI could allow physicians and researchers to search for clues about the best timing for surgery by combing through millions of x-rays, a variety of functional scores used in assessing patients, and other sources of information, she explained. At this time, the PCS used by Dr. Dust and colleagues is just one of many measures used to assess patient level of function. AI might be able to bring these data together for scientists to review.

“AI can see patterns that I can’t see right now,” Dr. Lajam said.

But she emphasized that any AI application would be an aid to physicians in counseling patients. Evaluation by an experienced surgeon, together with guidance from any AI tool, could provide a greater understanding of how TKA could help patients with arthritis of the knee.

“The physician sees intangibles that AI would not see because we actually talk to the patient,” she explained.

Dr. Dust said there was no outside funding for the study and the authors and Dr. Lajam reported no relevant financial relationships. Dr. Singh said he has received consulting fees from AstraZeneca and institutional research support from Zimmer Biomet Holdings. He has received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America, and owns stock options in Atai Life Sciences. He is a member of the executive committee of Outcome Measures in Rheumatology (OMERACT), an organization that receives arms-length funding from eight companies.

A version of this article appeared on Medscape.com.

Click to read more from Federal Health Care Data Trends 2023.

Click to read more from Federal Health Care Data Trends 2023.

Click to read more from Federal Health Care Data Trends 2023.

In this issue: 

• Limb Loss and Prostheses
• Neurology
  • Traumatic Brain Injury
  • Alzheimer's and Dementia
  • Amyotrophic Lateral Sclerosis (ALS)
  • Parkinson's Disease
  • Migraine and Headache
• Cardiology
• Mental Health
  • Depression
  • Opioid Use Disorder
  • PTSD and Psychedelic Treatments
  • Homelessness
  • Eating Disorders
• Diabetes
• Rheumatoid Arthritis
• Respiratory illnesses
• Women's Health
  • Access to Care
  • Infertility
  • Pregnancy
• HPV and Related Cancers

In this issue: 

• Limb Loss and Prostheses
• Neurology
  • Traumatic Brain Injury
  • Alzheimer's and Dementia
  • Amyotrophic Lateral Sclerosis (ALS)
  • Parkinson's Disease
  • Migraine and Headache
• Cardiology
• Mental Health
  • Depression
  • Opioid Use Disorder
  • PTSD and Psychedelic Treatments
  • Homelessness
  • Eating Disorders
• Diabetes
• Rheumatoid Arthritis
• Respiratory illnesses
• Women's Health
  • Access to Care
  • Infertility
  • Pregnancy
• HPV and Related Cancers

In this issue: 

• Limb Loss and Prostheses
• Neurology
  • Traumatic Brain Injury
  • Alzheimer's and Dementia
  • Amyotrophic Lateral Sclerosis (ALS)
  • Parkinson's Disease
  • Migraine and Headache
• Cardiology
• Mental Health
  • Depression
  • Opioid Use Disorder
  • PTSD and Psychedelic Treatments
  • Homelessness
  • Eating Disorders
• Diabetes
• Rheumatoid Arthritis
• Respiratory illnesses
• Women's Health
  • Access to Care
  • Infertility
  • Pregnancy
• HPV and Related Cancers

Some physicians are frustrated that key information about implantable medical devices rarely makes it into electronic health records, despite a 10-year mandate on manufacturers to label these products with identifiers.

As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.

In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.

But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.

Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.

“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.

Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.

Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.

In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.

The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.

The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.

Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.

Setback for advocates

The movement toward UDI suffered a setback in June.

An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.

Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.

Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.

That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.

In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.

“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”

In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.

Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.

But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.

Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.

“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”

The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.

A version of this article first appeared on Medscape.com.

Some physicians are frustrated that key information about implantable medical devices rarely makes it into electronic health records, despite a 10-year mandate on manufacturers to label these products with identifiers.

As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.

In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.

But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.

Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.

“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.

Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.

Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.

In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.

The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.

The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.

Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.

Setback for advocates

The movement toward UDI suffered a setback in June.

An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.

Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.

Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.

That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.

In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.

“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”

In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.

Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.

But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.

Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.

“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”

The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.

A version of this article first appeared on Medscape.com.

Some physicians are frustrated that key information about implantable medical devices rarely makes it into electronic health records, despite a 10-year mandate on manufacturers to label these products with identifiers.

As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.

In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.

But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.

Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.

“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.

Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.

Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.

In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.

The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.

The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.

Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.

Setback for advocates

The movement toward UDI suffered a setback in June.

An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.

Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.

Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.

That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.

In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.

“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”

In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.

Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.

But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.

Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.

“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”

The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.
 

F. Perry Wilson, MD, MSCE: I am joined today by Dr. Ohad Einav. He’s a staff surgeon in orthopedics at Hadassah Medical Center in Jerusalem. He’s with me to talk about an absolutely incredible surgical case, something that is terrifying to most non–orthopedic surgeons and I imagine is fairly scary for spine surgeons like him as well. It’s a case of internal decapitation that has generated a lot of news around the world because it happened to a young boy. But what we don’t have is information about how this works from a medical perspective. So, first of all, Dr. Einav, thank you for taking time to speak with me today.

Ohad Einav, MD: Thank you for having me.

Dr. Wilson: Can you tell us about Suleiman Hassan and what happened to him before he came into your care?

Dr. Einav: Hassan is a 12-year-old child who was riding his bicycle on the West Bank, about 40 minutes from here. Unfortunately, he was involved in a motor vehicle accident and he suffered injuries to his abdomen and cervical spine. He was transported to our service by helicopter from the scene of the accident.

Hadassah Medical Center

Hadassah Medical Center

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.
 

F. Perry Wilson, MD, MSCE: I am joined today by Dr. Ohad Einav. He’s a staff surgeon in orthopedics at Hadassah Medical Center in Jerusalem. He’s with me to talk about an absolutely incredible surgical case, something that is terrifying to most non–orthopedic surgeons and I imagine is fairly scary for spine surgeons like him as well. It’s a case of internal decapitation that has generated a lot of news around the world because it happened to a young boy. But what we don’t have is information about how this works from a medical perspective. So, first of all, Dr. Einav, thank you for taking time to speak with me today.

Ohad Einav, MD: Thank you for having me.

Dr. Wilson: Can you tell us about Suleiman Hassan and what happened to him before he came into your care?

Dr. Einav: Hassan is a 12-year-old child who was riding his bicycle on the West Bank, about 40 minutes from here. Unfortunately, he was involved in a motor vehicle accident and he suffered injuries to his abdomen and cervical spine. He was transported to our service by helicopter from the scene of the accident.

Hadassah Medical Center

Hadassah Medical Center

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.
 

F. Perry Wilson, MD, MSCE: I am joined today by Dr. Ohad Einav. He’s a staff surgeon in orthopedics at Hadassah Medical Center in Jerusalem. He’s with me to talk about an absolutely incredible surgical case, something that is terrifying to most non–orthopedic surgeons and I imagine is fairly scary for spine surgeons like him as well. It’s a case of internal decapitation that has generated a lot of news around the world because it happened to a young boy. But what we don’t have is information about how this works from a medical perspective. So, first of all, Dr. Einav, thank you for taking time to speak with me today.

Ohad Einav, MD: Thank you for having me.

Dr. Wilson: Can you tell us about Suleiman Hassan and what happened to him before he came into your care?

Dr. Einav: Hassan is a 12-year-old child who was riding his bicycle on the West Bank, about 40 minutes from here. Unfortunately, he was involved in a motor vehicle accident and he suffered injuries to his abdomen and cervical spine. He was transported to our service by helicopter from the scene of the accident.

Hadassah Medical Center

Hadassah Medical Center

A version of this article first appeared on Medscape.com.

We have long recognized that our environment has a significant impact on our general health. Air pollution is known to contribute to respiratory conditions, poor cardiovascular outcomes, and certain kinds of cancer. Less well-known (or studied) is the potential impact of such fumes on bone health.

It’s increasingly important to identify factors that might contribute to suboptimal bone density and associated fracture risk in the population as a whole, and particularly in older adults. Aging is associated with a higher risk for osteoporosis and fractures, with their attendant morbidity, but individuals differ in their extent of bone loss and risk for fractures.

Known factors affecting bone health include genetics, age, sex, nutrition, physical activity, and hormonal factors. Certain medications, diseases, and lifestyle choices – such as smoking and alcohol intake – can also have deleterious effects on bone.

More recently, researchers have started examining the impact of air pollution on bone health.

As we know, the degree of pollution varies greatly from one region to another and can potentially significantly affect life in many parts of the world. In fact, the World Health Organization indicates that 99% of the world’s population breathes air exceeding the WHO guideline limits for pollutants.

Air pollutants include particulate matter (PM) as well as gases, such as nitric oxide, nitrogen dioxide, ammonia, carbon monoxide, sulfur dioxide, ozone, and certain volatile organic compounds. Particulate pollutants include a variety of substances produced from mostly human activities (such as vehicle emissions, biofuel combustion, mining, agriculture, and manufacturing, and also forest fires). They are classified not by their composition, but by their size (for example, PM1.0, PM2.5, and PM10 indicate PM with a diameter < 1.0, 2.5, and 10 microns, respectively). The finer the particle, the more likely it is to cross into the systemic circulation from the respiratory tract, with the potential to induce oxidative, inflammatory, and other changes in the body.

Many studies report that air pollution is a risk factor for osteoporosis. Some have found associations of lower bone density, osteoporosis, and fracture risk with higher concentrations of PM1.0, PM2.5, or PM10, even after controlling for other factors that could affect bone health. Some researchers have reported that although they didn’t find a significant association between PM and bone health, they did find an association between distance from the freeway and bone health – thus, exposure to polycyclic aromatic hydrocarbons and black carbon from vehicle emissions needs to be studied as a contributor to fracture risk.

Importantly, a prospective, observational study from the Women’s Health Initiative (which included more than 9,000 ethnically diverse women from three sites in the United States) reported a significant negative impact of PM10, nitric oxide, nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years on bone density at multiple sites, and particularly at the lumbar spine, in both cross-sectional and longitudinal analyses after controlling for demographic and socioeconomic factors. This study reported that nitrogen dioxide exposure may be a key determinant of bone density at the lumbar spine and in the whole body. Similarly, other studies have reported associations between atmospheric nitrogen dioxide or sulfur dioxide and risk for osteoporotic fractures.
 

Why the impact on bones?

The potential negative impact of pollution on bone has been attributed to many factors. PM induces systemic inflammation and an increase in cytokines that stimulate bone cells (osteoclasts) that cause bone loss. Other pollutants (gases and metal compounds) can cause oxidative damage to bone cells, whereas others act as endocrine disrupters and affect the functioning of these cells.

Pollution might also affect the synthesis and metabolism of vitamin D, which is necessary for absorption of calcium from the gut. High rates of pollution can reduce the amount of ultraviolet radiation reaching the earth which is important because certain wavelengths of ultraviolet radiation are necessary for vitamin D synthesis in our skin. Reduced vitamin D synthesis in skin can lead to poorly mineralized bone unless there is sufficient intake of vitamin D in diet or as supplements. Also, the conversion of vitamin D to its active form happens in the kidneys, and PM can be harmful to renal function. PM is also believed to cause increased breakdown of vitamin D into its inactive form.

Conversely, some studies have reported no association between pollution and bone density or osteoporosis risk, and two meta-analyses indicated that the association between the two is inconsistent. Some factors explaining variances in results include the number of individuals included in the study (larger studies are generally considered to be more reproducible), the fact that most studies are cross-sectional and not prospective, many do not control for other factors that might be deleterious to bone, and prediction models for the extent of PM or other exposure may not be completely accurate.

However, another recent meta-analysis reported an increased risk for lower total-body bone density and hip fracture after exposure to air pollution, particularly PM2.5 and nitrogen dioxide, but not to PM10, nitric oxide, or ozone. More studies are needed to confirm, or refute, the association between air pollution and impaired bone health. But accumulating evidence suggests that air pollution very likely has a deleterious effect on bone.

When feasible, it’s important to avoid living or working in areas with poor air quality and high pollution rates. However, this isn’t always possible based on one’s occupation, geography, circumstances, or economic status. Therefore, attention to a cleaner environment is critical at both the individual and the macro level.

As an example of the latter, the city of London extended its ultralow emission zone (ULEZ) farther out of the city in October 2021, and a further expansion is planned to include all of the city’s boroughs in August 2023.

We can do our bit by driving less and walking, biking, or using public transportation more often. We can also turn off the car engine when it’s not running, maintain our vehicles, switch to electric or hand-powered yard equipment, and not burn household garbage and limit backyard fires. We can also switch from gas to solar energy or wind, use efficient appliances and heating, and avoid unnecessary energy use. And we can choose sustainable products when possible.

For optimal bone health, we should remind patients to eat a healthy diet with the requisite amount of protein, calcium, and vitamin D. Vitamin D and calcium supplementation may be necessary for people whose intake of dairy and dairy products is low. Other important strategies to optimize bone health include engaging in healthy physical activity; avoiding smoking or excessive alcohol intake; and treating underlying gastrointestinal, endocrine, or other conditions that can reduce bone density.

Madhusmita Misra, MD, MPH, is the chief of the division of pediatric endocrinology, Mass General for Children; the associate director of the Harvard Catalyst Translation and Clinical Research Center; and the director of the Pediatric Endocrine-Sports Endocrine-Neuroendocrine Lab, Mass General Hospital, Boston.

A version of this article first appeared on Medscape.com.

We have long recognized that our environment has a significant impact on our general health. Air pollution is known to contribute to respiratory conditions, poor cardiovascular outcomes, and certain kinds of cancer. Less well-known (or studied) is the potential impact of such fumes on bone health.

It’s increasingly important to identify factors that might contribute to suboptimal bone density and associated fracture risk in the population as a whole, and particularly in older adults. Aging is associated with a higher risk for osteoporosis and fractures, with their attendant morbidity, but individuals differ in their extent of bone loss and risk for fractures.

Known factors affecting bone health include genetics, age, sex, nutrition, physical activity, and hormonal factors. Certain medications, diseases, and lifestyle choices – such as smoking and alcohol intake – can also have deleterious effects on bone.

More recently, researchers have started examining the impact of air pollution on bone health.

As we know, the degree of pollution varies greatly from one region to another and can potentially significantly affect life in many parts of the world. In fact, the World Health Organization indicates that 99% of the world’s population breathes air exceeding the WHO guideline limits for pollutants.

Air pollutants include particulate matter (PM) as well as gases, such as nitric oxide, nitrogen dioxide, ammonia, carbon monoxide, sulfur dioxide, ozone, and certain volatile organic compounds. Particulate pollutants include a variety of substances produced from mostly human activities (such as vehicle emissions, biofuel combustion, mining, agriculture, and manufacturing, and also forest fires). They are classified not by their composition, but by their size (for example, PM1.0, PM2.5, and PM10 indicate PM with a diameter < 1.0, 2.5, and 10 microns, respectively). The finer the particle, the more likely it is to cross into the systemic circulation from the respiratory tract, with the potential to induce oxidative, inflammatory, and other changes in the body.

Many studies report that air pollution is a risk factor for osteoporosis. Some have found associations of lower bone density, osteoporosis, and fracture risk with higher concentrations of PM1.0, PM2.5, or PM10, even after controlling for other factors that could affect bone health. Some researchers have reported that although they didn’t find a significant association between PM and bone health, they did find an association between distance from the freeway and bone health – thus, exposure to polycyclic aromatic hydrocarbons and black carbon from vehicle emissions needs to be studied as a contributor to fracture risk.

Importantly, a prospective, observational study from the Women’s Health Initiative (which included more than 9,000 ethnically diverse women from three sites in the United States) reported a significant negative impact of PM10, nitric oxide, nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years on bone density at multiple sites, and particularly at the lumbar spine, in both cross-sectional and longitudinal analyses after controlling for demographic and socioeconomic factors. This study reported that nitrogen dioxide exposure may be a key determinant of bone density at the lumbar spine and in the whole body. Similarly, other studies have reported associations between atmospheric nitrogen dioxide or sulfur dioxide and risk for osteoporotic fractures.
 

Why the impact on bones?

The potential negative impact of pollution on bone has been attributed to many factors. PM induces systemic inflammation and an increase in cytokines that stimulate bone cells (osteoclasts) that cause bone loss. Other pollutants (gases and metal compounds) can cause oxidative damage to bone cells, whereas others act as endocrine disrupters and affect the functioning of these cells.

Pollution might also affect the synthesis and metabolism of vitamin D, which is necessary for absorption of calcium from the gut. High rates of pollution can reduce the amount of ultraviolet radiation reaching the earth which is important because certain wavelengths of ultraviolet radiation are necessary for vitamin D synthesis in our skin. Reduced vitamin D synthesis in skin can lead to poorly mineralized bone unless there is sufficient intake of vitamin D in diet or as supplements. Also, the conversion of vitamin D to its active form happens in the kidneys, and PM can be harmful to renal function. PM is also believed to cause increased breakdown of vitamin D into its inactive form.

Conversely, some studies have reported no association between pollution and bone density or osteoporosis risk, and two meta-analyses indicated that the association between the two is inconsistent. Some factors explaining variances in results include the number of individuals included in the study (larger studies are generally considered to be more reproducible), the fact that most studies are cross-sectional and not prospective, many do not control for other factors that might be deleterious to bone, and prediction models for the extent of PM or other exposure may not be completely accurate.

However, another recent meta-analysis reported an increased risk for lower total-body bone density and hip fracture after exposure to air pollution, particularly PM2.5 and nitrogen dioxide, but not to PM10, nitric oxide, or ozone. More studies are needed to confirm, or refute, the association between air pollution and impaired bone health. But accumulating evidence suggests that air pollution very likely has a deleterious effect on bone.

When feasible, it’s important to avoid living or working in areas with poor air quality and high pollution rates. However, this isn’t always possible based on one’s occupation, geography, circumstances, or economic status. Therefore, attention to a cleaner environment is critical at both the individual and the macro level.

As an example of the latter, the city of London extended its ultralow emission zone (ULEZ) farther out of the city in October 2021, and a further expansion is planned to include all of the city’s boroughs in August 2023.

We can do our bit by driving less and walking, biking, or using public transportation more often. We can also turn off the car engine when it’s not running, maintain our vehicles, switch to electric or hand-powered yard equipment, and not burn household garbage and limit backyard fires. We can also switch from gas to solar energy or wind, use efficient appliances and heating, and avoid unnecessary energy use. And we can choose sustainable products when possible.

For optimal bone health, we should remind patients to eat a healthy diet with the requisite amount of protein, calcium, and vitamin D. Vitamin D and calcium supplementation may be necessary for people whose intake of dairy and dairy products is low. Other important strategies to optimize bone health include engaging in healthy physical activity; avoiding smoking or excessive alcohol intake; and treating underlying gastrointestinal, endocrine, or other conditions that can reduce bone density.

Madhusmita Misra, MD, MPH, is the chief of the division of pediatric endocrinology, Mass General for Children; the associate director of the Harvard Catalyst Translation and Clinical Research Center; and the director of the Pediatric Endocrine-Sports Endocrine-Neuroendocrine Lab, Mass General Hospital, Boston.

A version of this article first appeared on Medscape.com.

We have long recognized that our environment has a significant impact on our general health. Air pollution is known to contribute to respiratory conditions, poor cardiovascular outcomes, and certain kinds of cancer. Less well-known (or studied) is the potential impact of such fumes on bone health.

It’s increasingly important to identify factors that might contribute to suboptimal bone density and associated fracture risk in the population as a whole, and particularly in older adults. Aging is associated with a higher risk for osteoporosis and fractures, with their attendant morbidity, but individuals differ in their extent of bone loss and risk for fractures.

Known factors affecting bone health include genetics, age, sex, nutrition, physical activity, and hormonal factors. Certain medications, diseases, and lifestyle choices – such as smoking and alcohol intake – can also have deleterious effects on bone.

More recently, researchers have started examining the impact of air pollution on bone health.

As we know, the degree of pollution varies greatly from one region to another and can potentially significantly affect life in many parts of the world. In fact, the World Health Organization indicates that 99% of the world’s population breathes air exceeding the WHO guideline limits for pollutants.

Air pollutants include particulate matter (PM) as well as gases, such as nitric oxide, nitrogen dioxide, ammonia, carbon monoxide, sulfur dioxide, ozone, and certain volatile organic compounds. Particulate pollutants include a variety of substances produced from mostly human activities (such as vehicle emissions, biofuel combustion, mining, agriculture, and manufacturing, and also forest fires). They are classified not by their composition, but by their size (for example, PM1.0, PM2.5, and PM10 indicate PM with a diameter < 1.0, 2.5, and 10 microns, respectively). The finer the particle, the more likely it is to cross into the systemic circulation from the respiratory tract, with the potential to induce oxidative, inflammatory, and other changes in the body.

Many studies report that air pollution is a risk factor for osteoporosis. Some have found associations of lower bone density, osteoporosis, and fracture risk with higher concentrations of PM1.0, PM2.5, or PM10, even after controlling for other factors that could affect bone health. Some researchers have reported that although they didn’t find a significant association between PM and bone health, they did find an association between distance from the freeway and bone health – thus, exposure to polycyclic aromatic hydrocarbons and black carbon from vehicle emissions needs to be studied as a contributor to fracture risk.

Importantly, a prospective, observational study from the Women’s Health Initiative (which included more than 9,000 ethnically diverse women from three sites in the United States) reported a significant negative impact of PM10, nitric oxide, nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years on bone density at multiple sites, and particularly at the lumbar spine, in both cross-sectional and longitudinal analyses after controlling for demographic and socioeconomic factors. This study reported that nitrogen dioxide exposure may be a key determinant of bone density at the lumbar spine and in the whole body. Similarly, other studies have reported associations between atmospheric nitrogen dioxide or sulfur dioxide and risk for osteoporotic fractures.
 

Why the impact on bones?

The potential negative impact of pollution on bone has been attributed to many factors. PM induces systemic inflammation and an increase in cytokines that stimulate bone cells (osteoclasts) that cause bone loss. Other pollutants (gases and metal compounds) can cause oxidative damage to bone cells, whereas others act as endocrine disrupters and affect the functioning of these cells.

Pollution might also affect the synthesis and metabolism of vitamin D, which is necessary for absorption of calcium from the gut. High rates of pollution can reduce the amount of ultraviolet radiation reaching the earth which is important because certain wavelengths of ultraviolet radiation are necessary for vitamin D synthesis in our skin. Reduced vitamin D synthesis in skin can lead to poorly mineralized bone unless there is sufficient intake of vitamin D in diet or as supplements. Also, the conversion of vitamin D to its active form happens in the kidneys, and PM can be harmful to renal function. PM is also believed to cause increased breakdown of vitamin D into its inactive form.

Conversely, some studies have reported no association between pollution and bone density or osteoporosis risk, and two meta-analyses indicated that the association between the two is inconsistent. Some factors explaining variances in results include the number of individuals included in the study (larger studies are generally considered to be more reproducible), the fact that most studies are cross-sectional and not prospective, many do not control for other factors that might be deleterious to bone, and prediction models for the extent of PM or other exposure may not be completely accurate.

However, another recent meta-analysis reported an increased risk for lower total-body bone density and hip fracture after exposure to air pollution, particularly PM2.5 and nitrogen dioxide, but not to PM10, nitric oxide, or ozone. More studies are needed to confirm, or refute, the association between air pollution and impaired bone health. But accumulating evidence suggests that air pollution very likely has a deleterious effect on bone.

When feasible, it’s important to avoid living or working in areas with poor air quality and high pollution rates. However, this isn’t always possible based on one’s occupation, geography, circumstances, or economic status. Therefore, attention to a cleaner environment is critical at both the individual and the macro level.

As an example of the latter, the city of London extended its ultralow emission zone (ULEZ) farther out of the city in October 2021, and a further expansion is planned to include all of the city’s boroughs in August 2023.

We can do our bit by driving less and walking, biking, or using public transportation more often. We can also turn off the car engine when it’s not running, maintain our vehicles, switch to electric or hand-powered yard equipment, and not burn household garbage and limit backyard fires. We can also switch from gas to solar energy or wind, use efficient appliances and heating, and avoid unnecessary energy use. And we can choose sustainable products when possible.

For optimal bone health, we should remind patients to eat a healthy diet with the requisite amount of protein, calcium, and vitamin D. Vitamin D and calcium supplementation may be necessary for people whose intake of dairy and dairy products is low. Other important strategies to optimize bone health include engaging in healthy physical activity; avoiding smoking or excessive alcohol intake; and treating underlying gastrointestinal, endocrine, or other conditions that can reduce bone density.

Madhusmita Misra, MD, MPH, is the chief of the division of pediatric endocrinology, Mass General for Children; the associate director of the Harvard Catalyst Translation and Clinical Research Center; and the director of the Pediatric Endocrine-Sports Endocrine-Neuroendocrine Lab, Mass General Hospital, Boston.

A version of this article first appeared on Medscape.com.

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.