Orthopedics

TOPLINE:

Patients who undergo surgery for carpal tunnel syndrome (CTS) may have an increased risk of developing incident diabetes, showed a recent study.

METHODOLOGY:

• Diabetes has been shown to be a risk factor for CTS, the most common entrapment neuropathy, but it remains unclear whether CTS is associated with subsequent diabetes.
• Researchers used data from Danish national registries to evaluate the odds of developing diabetes in 83,466 patients (median age, 54 years; 67% women) who underwent surgery for CTS between January 1996 and December 2018.
• The study compared the risk of developing diabetes in patients who had CTS surgery with that of an age- and sex-matched cohort of individuals from the general population in a 1:5 ratio (n = 417,330).
• Patients were followed (median of 7.6 years) until either a diagnosis of diabetes during hospitalization or a prescription of a glucose-lowering drug, or until either death, emigration, or the end of the study period.
• Cause-specific Cox proportional hazard models were used to compare the odds of developing diabetes between the two groups.

TAKEAWAY:

• The cumulative incidence of diabetes was higher in the CTS group than in the age-matched controls (16.8% vs 10.3%).
• Patients who underwent surgery for CTS were at a higher risk of developing diabetes within 1 year of surgery (hazard ratio [HR], 1.72) and during the rest of the study period (> 1 year: HR, 1.66).
• The risk for incident diabetes after CTS surgery was higher among younger patients aged 18-39 years (adjusted HR, 2.77) than among older patients aged 70-79 years (adjusted HR, 1.29).
• Also, patients who had bilateral surgery had a higher risk of developing diabetes than the matched control population (adjusted HR, 1.86).

IN PRACTICE:

“Identifying patients who are at risk of DM [diabetes mellitus] may mediate earlier initiation of preventive strategies. However, other factors, such as obesity and A1c levels, may affect the association,” the authors wrote.

SOURCE:

The study led by Jeppe Ravn Jacobsen, MB, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, was published online in Diabetes, Obesity, and Metabolism .

LIMITATIONS:

The study did not find an association between CTS and a future diagnosis of type 1 diabetes, which may be attributed to the fact that patients younger than 18 years were excluded. A proportion of the patients who underwent CTS may have had undetected prediabetes or diabetes at the time of CTS surgery. Moreover, the registry lacked information on potential confounders such as body mass index, smoking history, and blood samples. The association between CTS and diabetes may be attributable to shared risk factors for both, such as obesity.

DISCLOSURES:

The study was funded by an internal grant from the Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark. The authors declared no conflicts of interest.

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

TOPLINE:

Patients who undergo surgery for carpal tunnel syndrome (CTS) may have an increased risk of developing incident diabetes, showed a recent study.

METHODOLOGY:

• Diabetes has been shown to be a risk factor for CTS, the most common entrapment neuropathy, but it remains unclear whether CTS is associated with subsequent diabetes.
• Researchers used data from Danish national registries to evaluate the odds of developing diabetes in 83,466 patients (median age, 54 years; 67% women) who underwent surgery for CTS between January 1996 and December 2018.
• The study compared the risk of developing diabetes in patients who had CTS surgery with that of an age- and sex-matched cohort of individuals from the general population in a 1:5 ratio (n = 417,330).
• Patients were followed (median of 7.6 years) until either a diagnosis of diabetes during hospitalization or a prescription of a glucose-lowering drug, or until either death, emigration, or the end of the study period.
• Cause-specific Cox proportional hazard models were used to compare the odds of developing diabetes between the two groups.

TAKEAWAY:

• The cumulative incidence of diabetes was higher in the CTS group than in the age-matched controls (16.8% vs 10.3%).
• Patients who underwent surgery for CTS were at a higher risk of developing diabetes within 1 year of surgery (hazard ratio [HR], 1.72) and during the rest of the study period (> 1 year: HR, 1.66).
• The risk for incident diabetes after CTS surgery was higher among younger patients aged 18-39 years (adjusted HR, 2.77) than among older patients aged 70-79 years (adjusted HR, 1.29).
• Also, patients who had bilateral surgery had a higher risk of developing diabetes than the matched control population (adjusted HR, 1.86).

IN PRACTICE:

“Identifying patients who are at risk of DM [diabetes mellitus] may mediate earlier initiation of preventive strategies. However, other factors, such as obesity and A1c levels, may affect the association,” the authors wrote.

SOURCE:

The study led by Jeppe Ravn Jacobsen, MB, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, was published online in Diabetes, Obesity, and Metabolism .

LIMITATIONS:

The study did not find an association between CTS and a future diagnosis of type 1 diabetes, which may be attributed to the fact that patients younger than 18 years were excluded. A proportion of the patients who underwent CTS may have had undetected prediabetes or diabetes at the time of CTS surgery. Moreover, the registry lacked information on potential confounders such as body mass index, smoking history, and blood samples. The association between CTS and diabetes may be attributable to shared risk factors for both, such as obesity.

DISCLOSURES:

The study was funded by an internal grant from the Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark. The authors declared no conflicts of interest.

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

TOPLINE:

Patients who undergo surgery for carpal tunnel syndrome (CTS) may have an increased risk of developing incident diabetes, showed a recent study.

METHODOLOGY:

• Diabetes has been shown to be a risk factor for CTS, the most common entrapment neuropathy, but it remains unclear whether CTS is associated with subsequent diabetes.
• Researchers used data from Danish national registries to evaluate the odds of developing diabetes in 83,466 patients (median age, 54 years; 67% women) who underwent surgery for CTS between January 1996 and December 2018.
• The study compared the risk of developing diabetes in patients who had CTS surgery with that of an age- and sex-matched cohort of individuals from the general population in a 1:5 ratio (n = 417,330).
• Patients were followed (median of 7.6 years) until either a diagnosis of diabetes during hospitalization or a prescription of a glucose-lowering drug, or until either death, emigration, or the end of the study period.
• Cause-specific Cox proportional hazard models were used to compare the odds of developing diabetes between the two groups.

TAKEAWAY:

• The cumulative incidence of diabetes was higher in the CTS group than in the age-matched controls (16.8% vs 10.3%).
• Patients who underwent surgery for CTS were at a higher risk of developing diabetes within 1 year of surgery (hazard ratio [HR], 1.72) and during the rest of the study period (> 1 year: HR, 1.66).
• The risk for incident diabetes after CTS surgery was higher among younger patients aged 18-39 years (adjusted HR, 2.77) than among older patients aged 70-79 years (adjusted HR, 1.29).
• Also, patients who had bilateral surgery had a higher risk of developing diabetes than the matched control population (adjusted HR, 1.86).

IN PRACTICE:

“Identifying patients who are at risk of DM [diabetes mellitus] may mediate earlier initiation of preventive strategies. However, other factors, such as obesity and A1c levels, may affect the association,” the authors wrote.

SOURCE:

The study led by Jeppe Ravn Jacobsen, MB, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, was published online in Diabetes, Obesity, and Metabolism .

LIMITATIONS:

The study did not find an association between CTS and a future diagnosis of type 1 diabetes, which may be attributed to the fact that patients younger than 18 years were excluded. A proportion of the patients who underwent CTS may have had undetected prediabetes or diabetes at the time of CTS surgery. Moreover, the registry lacked information on potential confounders such as body mass index, smoking history, and blood samples. The association between CTS and diabetes may be attributable to shared risk factors for both, such as obesity.

DISCLOSURES:

The study was funded by an internal grant from the Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark. The authors declared no conflicts of interest.

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

Cervical manipulations have been associated with vascular complications. While the incidence of carotid dissections does not seem to have increased, the question remains open for vertebral artery injuries. We must remain vigilant!

Resorting to joint manipulation for neck pain is not unusual. Currently, cervical manipulation remains a popular first-line treatment for cervicodynia or headaches. Although evidence exists showing that specific joint mobilization can improve this type of symptomatology, there is a possibility that it may risk damaging the cervical arteries and causing ischemic stroke through arterial dissection.

Epidemiologically, internal carotid artery dissection is a relatively rare event with an estimated annual incidence of 1.72 per 100,000 individuals (those most likely to be diagnosed being obviously those leading to hospitalization for stroke) but represents one of the most common causes of stroke in young and middle-aged adults. Faced with case reports that may raise concerns and hypotheses about an associated risk, two studies have sought to delve into the issue.
 

No Increased Carotid Risk Identified

The first study, of a case-cross design, identified all incident cases of ischemic stroke in the territory of the internal carotid artery admitted to the hospital over a 9-year period using administrative healthcare data, the cases being used as their own control by sampling control periods before the date of the index stroke. Thus, 15,523 cases were compared with 62,092 control periods using exposure windows of 1, 3, 7, and 14 days before the stroke. The study also compared post-medical consultation and post-chiropractic consultation outcomes, knowing that as a first-line for complaints of neck pain or headache, patients often turn to one of these two types of primary care clinicians.

However, data analysis shows, among subjects aged under 45 years, positive associations for both different consultations in cases of subsequent carotid stroke (but no association for those aged over 45 years). These associations tended to increase when analyses were limited to visits for diagnoses of neck pain and headaches. Nevertheless, there was no significant difference between risk estimates after chiropractic or general medical consultation.

A notable limitation of this work is that it did not focus on strokes due to vertebral artery dissections that run through the transverse foramina of the cervical vertebrae.
 

A Screening Test Lacking Precision

More recently, the International Federation of Orthopedic Manual Physical Therapists has looked into the subject to refine the assessment of the risk for vascular complications in patients seeking physiotherapy/osteopathy care for neck pain and/or headaches. Through a cross-sectional study involving 150 patients, it tested a vascular complication risk index (from high to low grade, based on history taking and clinical examination), developed to estimate the risk for the presence of vascular rather than musculoskeletal pathology, to determine whether or not there is a contraindication to cervical manipulation.

However, the developed index had only low sensitivity (0.50; 95% CI, 0.39-0.61) and moderate specificity (0.63; 95% CI, 0.51-0.75), knowing that the reference test was a consensus medical decision made by a vascular neurologist, an interventional neurologist, and a neuroradiologist (based on clinical data and cervical MRI). Similarly, positive and negative likelihood ratios were low at 1.36 (95% CI, 0.93-1.99) and 0.79 (95% CI, 0.60-1.05), respectively.

In conclusion, the data from the case-cross study did not seem to demonstrate an excess risk for stroke in the territory of the internal carotid artery after cervical joint manipulations. Associations between cervical manipulation sessions or medical consultations and carotid strokes appear similar and could have been due to the fact that patients with early symptoms related to arterial dissection seek care before developing their stroke.

However, it is regrettable that the study did not focus on vertebral artery dissections, which are anatomically more exposed to cervical chiropractic sessions. Nevertheless, because indices defined from joint tests and medical history are insufficient to identify patients “at risk or in the process of arterial dissection,” and because stroke can result in severe disability, practitioners managing patients with neck pain cannot take this type of complication lightly.

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Cervical manipulations have been associated with vascular complications. While the incidence of carotid dissections does not seem to have increased, the question remains open for vertebral artery injuries. We must remain vigilant!

Resorting to joint manipulation for neck pain is not unusual. Currently, cervical manipulation remains a popular first-line treatment for cervicodynia or headaches. Although evidence exists showing that specific joint mobilization can improve this type of symptomatology, there is a possibility that it may risk damaging the cervical arteries and causing ischemic stroke through arterial dissection.

Epidemiologically, internal carotid artery dissection is a relatively rare event with an estimated annual incidence of 1.72 per 100,000 individuals (those most likely to be diagnosed being obviously those leading to hospitalization for stroke) but represents one of the most common causes of stroke in young and middle-aged adults. Faced with case reports that may raise concerns and hypotheses about an associated risk, two studies have sought to delve into the issue.
 

No Increased Carotid Risk Identified

The first study, of a case-cross design, identified all incident cases of ischemic stroke in the territory of the internal carotid artery admitted to the hospital over a 9-year period using administrative healthcare data, the cases being used as their own control by sampling control periods before the date of the index stroke. Thus, 15,523 cases were compared with 62,092 control periods using exposure windows of 1, 3, 7, and 14 days before the stroke. The study also compared post-medical consultation and post-chiropractic consultation outcomes, knowing that as a first-line for complaints of neck pain or headache, patients often turn to one of these two types of primary care clinicians.

However, data analysis shows, among subjects aged under 45 years, positive associations for both different consultations in cases of subsequent carotid stroke (but no association for those aged over 45 years). These associations tended to increase when analyses were limited to visits for diagnoses of neck pain and headaches. Nevertheless, there was no significant difference between risk estimates after chiropractic or general medical consultation.

A notable limitation of this work is that it did not focus on strokes due to vertebral artery dissections that run through the transverse foramina of the cervical vertebrae.
 

A Screening Test Lacking Precision

More recently, the International Federation of Orthopedic Manual Physical Therapists has looked into the subject to refine the assessment of the risk for vascular complications in patients seeking physiotherapy/osteopathy care for neck pain and/or headaches. Through a cross-sectional study involving 150 patients, it tested a vascular complication risk index (from high to low grade, based on history taking and clinical examination), developed to estimate the risk for the presence of vascular rather than musculoskeletal pathology, to determine whether or not there is a contraindication to cervical manipulation.

However, the developed index had only low sensitivity (0.50; 95% CI, 0.39-0.61) and moderate specificity (0.63; 95% CI, 0.51-0.75), knowing that the reference test was a consensus medical decision made by a vascular neurologist, an interventional neurologist, and a neuroradiologist (based on clinical data and cervical MRI). Similarly, positive and negative likelihood ratios were low at 1.36 (95% CI, 0.93-1.99) and 0.79 (95% CI, 0.60-1.05), respectively.

In conclusion, the data from the case-cross study did not seem to demonstrate an excess risk for stroke in the territory of the internal carotid artery after cervical joint manipulations. Associations between cervical manipulation sessions or medical consultations and carotid strokes appear similar and could have been due to the fact that patients with early symptoms related to arterial dissection seek care before developing their stroke.

However, it is regrettable that the study did not focus on vertebral artery dissections, which are anatomically more exposed to cervical chiropractic sessions. Nevertheless, because indices defined from joint tests and medical history are insufficient to identify patients “at risk or in the process of arterial dissection,” and because stroke can result in severe disability, practitioners managing patients with neck pain cannot take this type of complication lightly.

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Cervical manipulations have been associated with vascular complications. While the incidence of carotid dissections does not seem to have increased, the question remains open for vertebral artery injuries. We must remain vigilant!

Resorting to joint manipulation for neck pain is not unusual. Currently, cervical manipulation remains a popular first-line treatment for cervicodynia or headaches. Although evidence exists showing that specific joint mobilization can improve this type of symptomatology, there is a possibility that it may risk damaging the cervical arteries and causing ischemic stroke through arterial dissection.

Epidemiologically, internal carotid artery dissection is a relatively rare event with an estimated annual incidence of 1.72 per 100,000 individuals (those most likely to be diagnosed being obviously those leading to hospitalization for stroke) but represents one of the most common causes of stroke in young and middle-aged adults. Faced with case reports that may raise concerns and hypotheses about an associated risk, two studies have sought to delve into the issue.
 

No Increased Carotid Risk Identified

The first study, of a case-cross design, identified all incident cases of ischemic stroke in the territory of the internal carotid artery admitted to the hospital over a 9-year period using administrative healthcare data, the cases being used as their own control by sampling control periods before the date of the index stroke. Thus, 15,523 cases were compared with 62,092 control periods using exposure windows of 1, 3, 7, and 14 days before the stroke. The study also compared post-medical consultation and post-chiropractic consultation outcomes, knowing that as a first-line for complaints of neck pain or headache, patients often turn to one of these two types of primary care clinicians.

However, data analysis shows, among subjects aged under 45 years, positive associations for both different consultations in cases of subsequent carotid stroke (but no association for those aged over 45 years). These associations tended to increase when analyses were limited to visits for diagnoses of neck pain and headaches. Nevertheless, there was no significant difference between risk estimates after chiropractic or general medical consultation.

A notable limitation of this work is that it did not focus on strokes due to vertebral artery dissections that run through the transverse foramina of the cervical vertebrae.
 

A Screening Test Lacking Precision

More recently, the International Federation of Orthopedic Manual Physical Therapists has looked into the subject to refine the assessment of the risk for vascular complications in patients seeking physiotherapy/osteopathy care for neck pain and/or headaches. Through a cross-sectional study involving 150 patients, it tested a vascular complication risk index (from high to low grade, based on history taking and clinical examination), developed to estimate the risk for the presence of vascular rather than musculoskeletal pathology, to determine whether or not there is a contraindication to cervical manipulation.

However, the developed index had only low sensitivity (0.50; 95% CI, 0.39-0.61) and moderate specificity (0.63; 95% CI, 0.51-0.75), knowing that the reference test was a consensus medical decision made by a vascular neurologist, an interventional neurologist, and a neuroradiologist (based on clinical data and cervical MRI). Similarly, positive and negative likelihood ratios were low at 1.36 (95% CI, 0.93-1.99) and 0.79 (95% CI, 0.60-1.05), respectively.

In conclusion, the data from the case-cross study did not seem to demonstrate an excess risk for stroke in the territory of the internal carotid artery after cervical joint manipulations. Associations between cervical manipulation sessions or medical consultations and carotid strokes appear similar and could have been due to the fact that patients with early symptoms related to arterial dissection seek care before developing their stroke.

However, it is regrettable that the study did not focus on vertebral artery dissections, which are anatomically more exposed to cervical chiropractic sessions. Nevertheless, because indices defined from joint tests and medical history are insufficient to identify patients “at risk or in the process of arterial dissection,” and because stroke can result in severe disability, practitioners managing patients with neck pain cannot take this type of complication lightly.

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

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.

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.

Federal Health Care Data Trends (click to view the digital edition) is a special supplement to Federal Practitioner, highlighting the latest research and study outcomes related to the health of veteran and active-duty populations.

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

Federal Health Care Data Trends (click to view the digital edition) is a special supplement to Federal Practitioner, highlighting the latest research and study outcomes related to the health of veteran and active-duty populations.

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

Federal Health Care Data Trends (click to view the digital edition) is a special supplement to Federal Practitioner, highlighting the latest research and study outcomes related to the health of veteran and active-duty populations.

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.