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Radiofrequency ablation blocks hip, shoulder arthritis pain
Osteoarthritis patients report significant pain relief after treatment with cooled radiofrequency ablation, a new technique that “stuns” sensory nerves in shoulder and hip joints to reduce – and sometimes eliminate – pain.
“We send a small current to the sensory nerve to heat up the tissue and disrupt the fibers,” study lead author Felix Gonzalez, MD, of Emory University, Atlanta, said in an interview. “The effect is that the transmission of pain is significantly slowed or halted altogether.
“We damage something to fix something,” Dr. Gonzalez continued. “We target only the problematic nerve and get a very localized effect.”
Two-phase treatment
The treatment is performed in two phases. First, patients with shoulder pain are given an anesthetic to block their suprascapular, lateral pectoral, and axillary sensory articular nerves. Patients with hip pain have their obturator and femoral sensory articular nerves blocked.
A week or two later, the same nerves are treated with cooled radiofrequency ablation. Guided by x-ray imaging, a clinician heats up the affected nerve tissue using the tip of a needle, which is pointed at the nerve. “It’s a 22-gauge needle, slightly thicker than an acupuncture needle,” Dr. Gonzalez explained. “We heat up the nerve for about 2 minutes to about 60 degrees Celsius – it stuns the nerve,” he said.
“The result disrupts or slows down pain transmission while leaving the nerve intact.”
To test the efficacy of the technique, researchers treated 12 shoulders in patients with an average age of 61 years, and 11 hips in patients with an average age of 62 years.
Three months after treatment, patients with hip pain reported improvement in Hip Disability and Osteoarthritis Outcome Score (HOOS) from a baseline of 17.0 to 52.9 (P < .0001).
Shoulder pain was also reduced significantly. Using the American Shoulder and Elbow Surgeons (ASES) score, researchers reported an improvement from 17.2 (±6.6) at baseline to 65.7 (±5.9) at 3 months (P < .0001).
“We are targeting a subset of patients for this that don’t qualify for surgery,” Dr. Gonzalez noted. For patients with a body mass index above 35, or a history of hypertension, heart disease, or multiple strokes, opioids are the most common treatment, he said.
These patients “fall through the cracks,” he explained. Those who have mild to moderate pain are managed with physical therapy and injections, and those with severe pain go into surgery. “But what about the ones in the middle ... who are not eligible for surgery? They are at risk for opioid overuse,” he said. “So this treatment is a good option for them.”
Treats the symptoms, not the cause
“This study shows the efficacy of this method in taking care of shoulder and hip pain,” Luca Maria Sconfienza, MD, PhD, of Galeazzi Orthopedic Hospital in Milan, said in an interview. Dr. Sconfienza was not involved in Dr. Gonzalez’s study.
However, like corticosteroid injections, “the drawback of radiofrequency ablation is the fact that it only treats the symptoms and not the cause, and efficacy is usually limited over time,” she said.
Dr. Sconfienza said this study leaves her with three pertinent questions. “First, whether pain control extends beyond the 3-month follow-up reported by authors in the abstract; second, [what] is the efficacy of this method compared to other interventions (e.g., physical therapy, injections) or to doing nothing; and last, radiofrequency ablation is usually not a cheap treatment, thus a cost-efficacy analysis would be desirable, especially in comparison to other procedures.”
Dr. Gonzalez and Dr. Sconfienza have nothing relevant to disclose.
A version of this article originally appeared on Medscape.com.
Osteoarthritis patients report significant pain relief after treatment with cooled radiofrequency ablation, a new technique that “stuns” sensory nerves in shoulder and hip joints to reduce – and sometimes eliminate – pain.
“We send a small current to the sensory nerve to heat up the tissue and disrupt the fibers,” study lead author Felix Gonzalez, MD, of Emory University, Atlanta, said in an interview. “The effect is that the transmission of pain is significantly slowed or halted altogether.
“We damage something to fix something,” Dr. Gonzalez continued. “We target only the problematic nerve and get a very localized effect.”
Two-phase treatment
The treatment is performed in two phases. First, patients with shoulder pain are given an anesthetic to block their suprascapular, lateral pectoral, and axillary sensory articular nerves. Patients with hip pain have their obturator and femoral sensory articular nerves blocked.
A week or two later, the same nerves are treated with cooled radiofrequency ablation. Guided by x-ray imaging, a clinician heats up the affected nerve tissue using the tip of a needle, which is pointed at the nerve. “It’s a 22-gauge needle, slightly thicker than an acupuncture needle,” Dr. Gonzalez explained. “We heat up the nerve for about 2 minutes to about 60 degrees Celsius – it stuns the nerve,” he said.
“The result disrupts or slows down pain transmission while leaving the nerve intact.”
To test the efficacy of the technique, researchers treated 12 shoulders in patients with an average age of 61 years, and 11 hips in patients with an average age of 62 years.
Three months after treatment, patients with hip pain reported improvement in Hip Disability and Osteoarthritis Outcome Score (HOOS) from a baseline of 17.0 to 52.9 (P < .0001).
Shoulder pain was also reduced significantly. Using the American Shoulder and Elbow Surgeons (ASES) score, researchers reported an improvement from 17.2 (±6.6) at baseline to 65.7 (±5.9) at 3 months (P < .0001).
“We are targeting a subset of patients for this that don’t qualify for surgery,” Dr. Gonzalez noted. For patients with a body mass index above 35, or a history of hypertension, heart disease, or multiple strokes, opioids are the most common treatment, he said.
These patients “fall through the cracks,” he explained. Those who have mild to moderate pain are managed with physical therapy and injections, and those with severe pain go into surgery. “But what about the ones in the middle ... who are not eligible for surgery? They are at risk for opioid overuse,” he said. “So this treatment is a good option for them.”
Treats the symptoms, not the cause
“This study shows the efficacy of this method in taking care of shoulder and hip pain,” Luca Maria Sconfienza, MD, PhD, of Galeazzi Orthopedic Hospital in Milan, said in an interview. Dr. Sconfienza was not involved in Dr. Gonzalez’s study.
However, like corticosteroid injections, “the drawback of radiofrequency ablation is the fact that it only treats the symptoms and not the cause, and efficacy is usually limited over time,” she said.
Dr. Sconfienza said this study leaves her with three pertinent questions. “First, whether pain control extends beyond the 3-month follow-up reported by authors in the abstract; second, [what] is the efficacy of this method compared to other interventions (e.g., physical therapy, injections) or to doing nothing; and last, radiofrequency ablation is usually not a cheap treatment, thus a cost-efficacy analysis would be desirable, especially in comparison to other procedures.”
Dr. Gonzalez and Dr. Sconfienza have nothing relevant to disclose.
A version of this article originally appeared on Medscape.com.
Osteoarthritis patients report significant pain relief after treatment with cooled radiofrequency ablation, a new technique that “stuns” sensory nerves in shoulder and hip joints to reduce – and sometimes eliminate – pain.
“We send a small current to the sensory nerve to heat up the tissue and disrupt the fibers,” study lead author Felix Gonzalez, MD, of Emory University, Atlanta, said in an interview. “The effect is that the transmission of pain is significantly slowed or halted altogether.
“We damage something to fix something,” Dr. Gonzalez continued. “We target only the problematic nerve and get a very localized effect.”
Two-phase treatment
The treatment is performed in two phases. First, patients with shoulder pain are given an anesthetic to block their suprascapular, lateral pectoral, and axillary sensory articular nerves. Patients with hip pain have their obturator and femoral sensory articular nerves blocked.
A week or two later, the same nerves are treated with cooled radiofrequency ablation. Guided by x-ray imaging, a clinician heats up the affected nerve tissue using the tip of a needle, which is pointed at the nerve. “It’s a 22-gauge needle, slightly thicker than an acupuncture needle,” Dr. Gonzalez explained. “We heat up the nerve for about 2 minutes to about 60 degrees Celsius – it stuns the nerve,” he said.
“The result disrupts or slows down pain transmission while leaving the nerve intact.”
To test the efficacy of the technique, researchers treated 12 shoulders in patients with an average age of 61 years, and 11 hips in patients with an average age of 62 years.
Three months after treatment, patients with hip pain reported improvement in Hip Disability and Osteoarthritis Outcome Score (HOOS) from a baseline of 17.0 to 52.9 (P < .0001).
Shoulder pain was also reduced significantly. Using the American Shoulder and Elbow Surgeons (ASES) score, researchers reported an improvement from 17.2 (±6.6) at baseline to 65.7 (±5.9) at 3 months (P < .0001).
“We are targeting a subset of patients for this that don’t qualify for surgery,” Dr. Gonzalez noted. For patients with a body mass index above 35, or a history of hypertension, heart disease, or multiple strokes, opioids are the most common treatment, he said.
These patients “fall through the cracks,” he explained. Those who have mild to moderate pain are managed with physical therapy and injections, and those with severe pain go into surgery. “But what about the ones in the middle ... who are not eligible for surgery? They are at risk for opioid overuse,” he said. “So this treatment is a good option for them.”
Treats the symptoms, not the cause
“This study shows the efficacy of this method in taking care of shoulder and hip pain,” Luca Maria Sconfienza, MD, PhD, of Galeazzi Orthopedic Hospital in Milan, said in an interview. Dr. Sconfienza was not involved in Dr. Gonzalez’s study.
However, like corticosteroid injections, “the drawback of radiofrequency ablation is the fact that it only treats the symptoms and not the cause, and efficacy is usually limited over time,” she said.
Dr. Sconfienza said this study leaves her with three pertinent questions. “First, whether pain control extends beyond the 3-month follow-up reported by authors in the abstract; second, [what] is the efficacy of this method compared to other interventions (e.g., physical therapy, injections) or to doing nothing; and last, radiofrequency ablation is usually not a cheap treatment, thus a cost-efficacy analysis would be desirable, especially in comparison to other procedures.”
Dr. Gonzalez and Dr. Sconfienza have nothing relevant to disclose.
A version of this article originally appeared on Medscape.com.
Warfarin use linked to knee and hip replacement in osteoarthritis patients
Patients who take the vitamin K antagonist warfarin to prevent thromboembolic events are significantly more likely to require knee or hip replacement surgery – a surrogate endpoint for end-stage osteoarthritis – than are patients who take direct oral anticoagulants (DOACs), results of a U.K.-based study showed.
In a nested case-control study, warfarin use was associated with a 1.5-fold risk for knee and hip replacement, compared with use of DOACs.
The findings provide additional evidence for the role of vitamin K and vitamin K–dependent proteins for limiting osteoarthritis progression, said lead author Priyanka Ballal, MD, a rheumatology fellow at Boston University.
“Given the prevalence and impact of osteoarthritis, our data, along with the existing literature, support the need for a well-powered, randomized, controlled trial for evaluating vitamin K supplementation in osteoarthritis. Our study also raises the consideration of using DOACs over warfarin when indicated in people with or at risk of osteoarthritis,“ she said in a plenary session at the virtual annual meeting of the American College of Rheumatology.
Warfarin targets vitamin K for its role in coagulation, but vitamin K is also an essential co-factor for vitamin K-dependent proteins in bone and cartilage, Dr. Ballal said,
Inadequate vitamin K levels are associated with abnormal joint tissue mineralization, and with increased incidence and prevalence of osteoarthritis. In a randomized, controlled trial, vitamin K supplementation was associated with trends toward less osteoarthritis progression among patients with vitamin K deficiency, she said.
To see whether warfarin therapy has biologic effects similar to that seen in patients with vitamin K deficiency, Dr. Ballal and colleagues conducted a nested, case-control study using data from The Health Improvement Network (THIN), an electronic medical record database of patients enrolled with general practitioners in the United Kingdom.
The sample included adults aged 40-80 years with atrial fibrillation who had received one or more prescriptions for warfarin or a DOAC beginning in 2009, a year after DOACs were first marketed in the United Kingdom, and within 1 year of the index date (date of joint replacement surgery). The researchers excluded patients with knee or hip replacements before 2014, severe comorbidities that would limit joint replacement, or who had used either warfarin or a DOAC prior to study entry. Each case was matched by age, gender, and index date with up to four control patients (those who did not have surgery).
A total of 913 cases and 3,652 controls were included. The groups had similar characteristics (sex, age, cancer, renal disease, chronic lung disease, hypertension, and incidence of venous thromboembolism [VTE]), except for somewhat higher rates of diabetes and heart failure among controls, and a higher rate of obesity among cases.
The investigators first looked at warfarin use among all knee and/or hip replacement cases and controls and calculated an odds ratio of 1.57 (95% confidence interval [CI], 1.30-1.89) for knee and hip replacement with warfarin after adjustment for body mass index, factors influencing choice of anticoagulant, comorbidities, other medications, general practitioner visits, and hospitalizations.
The association between warfarin and joint replacement held up in an analysis restricted to knee replacement only, with an adjusted OR of 1.48 (95% CI, 1.16-1.89).
There was also a clear association between duration of warfarin use and risk of knee and hip replacement.
“This abstract suggests the role of adequate vitamin K may be important in decreasing progression of osteoarthritis, which would then favor patients with OA who are on warfarin to consider changing to a DOAC; however, further studies are needed to confirm this finding and consider its impact on VTE and wound healing postop,” said Minna Kohler, MD, director of the rheumatology musculoskeletal ultrasound program at Massachusetts General Hospital in Boston. Dr. Kohler, who was not involved in the study, replied to an email request for comment.
The study was supported by grants from the National Institutes of Health. Dr. Ballal and Dr. Kohler reported having no conflicts of interest to disclose.
SOURCE: Ballal P et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0934.
Patients who take the vitamin K antagonist warfarin to prevent thromboembolic events are significantly more likely to require knee or hip replacement surgery – a surrogate endpoint for end-stage osteoarthritis – than are patients who take direct oral anticoagulants (DOACs), results of a U.K.-based study showed.
In a nested case-control study, warfarin use was associated with a 1.5-fold risk for knee and hip replacement, compared with use of DOACs.
The findings provide additional evidence for the role of vitamin K and vitamin K–dependent proteins for limiting osteoarthritis progression, said lead author Priyanka Ballal, MD, a rheumatology fellow at Boston University.
“Given the prevalence and impact of osteoarthritis, our data, along with the existing literature, support the need for a well-powered, randomized, controlled trial for evaluating vitamin K supplementation in osteoarthritis. Our study also raises the consideration of using DOACs over warfarin when indicated in people with or at risk of osteoarthritis,“ she said in a plenary session at the virtual annual meeting of the American College of Rheumatology.
Warfarin targets vitamin K for its role in coagulation, but vitamin K is also an essential co-factor for vitamin K-dependent proteins in bone and cartilage, Dr. Ballal said,
Inadequate vitamin K levels are associated with abnormal joint tissue mineralization, and with increased incidence and prevalence of osteoarthritis. In a randomized, controlled trial, vitamin K supplementation was associated with trends toward less osteoarthritis progression among patients with vitamin K deficiency, she said.
To see whether warfarin therapy has biologic effects similar to that seen in patients with vitamin K deficiency, Dr. Ballal and colleagues conducted a nested, case-control study using data from The Health Improvement Network (THIN), an electronic medical record database of patients enrolled with general practitioners in the United Kingdom.
The sample included adults aged 40-80 years with atrial fibrillation who had received one or more prescriptions for warfarin or a DOAC beginning in 2009, a year after DOACs were first marketed in the United Kingdom, and within 1 year of the index date (date of joint replacement surgery). The researchers excluded patients with knee or hip replacements before 2014, severe comorbidities that would limit joint replacement, or who had used either warfarin or a DOAC prior to study entry. Each case was matched by age, gender, and index date with up to four control patients (those who did not have surgery).
A total of 913 cases and 3,652 controls were included. The groups had similar characteristics (sex, age, cancer, renal disease, chronic lung disease, hypertension, and incidence of venous thromboembolism [VTE]), except for somewhat higher rates of diabetes and heart failure among controls, and a higher rate of obesity among cases.
The investigators first looked at warfarin use among all knee and/or hip replacement cases and controls and calculated an odds ratio of 1.57 (95% confidence interval [CI], 1.30-1.89) for knee and hip replacement with warfarin after adjustment for body mass index, factors influencing choice of anticoagulant, comorbidities, other medications, general practitioner visits, and hospitalizations.
The association between warfarin and joint replacement held up in an analysis restricted to knee replacement only, with an adjusted OR of 1.48 (95% CI, 1.16-1.89).
There was also a clear association between duration of warfarin use and risk of knee and hip replacement.
“This abstract suggests the role of adequate vitamin K may be important in decreasing progression of osteoarthritis, which would then favor patients with OA who are on warfarin to consider changing to a DOAC; however, further studies are needed to confirm this finding and consider its impact on VTE and wound healing postop,” said Minna Kohler, MD, director of the rheumatology musculoskeletal ultrasound program at Massachusetts General Hospital in Boston. Dr. Kohler, who was not involved in the study, replied to an email request for comment.
The study was supported by grants from the National Institutes of Health. Dr. Ballal and Dr. Kohler reported having no conflicts of interest to disclose.
SOURCE: Ballal P et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0934.
Patients who take the vitamin K antagonist warfarin to prevent thromboembolic events are significantly more likely to require knee or hip replacement surgery – a surrogate endpoint for end-stage osteoarthritis – than are patients who take direct oral anticoagulants (DOACs), results of a U.K.-based study showed.
In a nested case-control study, warfarin use was associated with a 1.5-fold risk for knee and hip replacement, compared with use of DOACs.
The findings provide additional evidence for the role of vitamin K and vitamin K–dependent proteins for limiting osteoarthritis progression, said lead author Priyanka Ballal, MD, a rheumatology fellow at Boston University.
“Given the prevalence and impact of osteoarthritis, our data, along with the existing literature, support the need for a well-powered, randomized, controlled trial for evaluating vitamin K supplementation in osteoarthritis. Our study also raises the consideration of using DOACs over warfarin when indicated in people with or at risk of osteoarthritis,“ she said in a plenary session at the virtual annual meeting of the American College of Rheumatology.
Warfarin targets vitamin K for its role in coagulation, but vitamin K is also an essential co-factor for vitamin K-dependent proteins in bone and cartilage, Dr. Ballal said,
Inadequate vitamin K levels are associated with abnormal joint tissue mineralization, and with increased incidence and prevalence of osteoarthritis. In a randomized, controlled trial, vitamin K supplementation was associated with trends toward less osteoarthritis progression among patients with vitamin K deficiency, she said.
To see whether warfarin therapy has biologic effects similar to that seen in patients with vitamin K deficiency, Dr. Ballal and colleagues conducted a nested, case-control study using data from The Health Improvement Network (THIN), an electronic medical record database of patients enrolled with general practitioners in the United Kingdom.
The sample included adults aged 40-80 years with atrial fibrillation who had received one or more prescriptions for warfarin or a DOAC beginning in 2009, a year after DOACs were first marketed in the United Kingdom, and within 1 year of the index date (date of joint replacement surgery). The researchers excluded patients with knee or hip replacements before 2014, severe comorbidities that would limit joint replacement, or who had used either warfarin or a DOAC prior to study entry. Each case was matched by age, gender, and index date with up to four control patients (those who did not have surgery).
A total of 913 cases and 3,652 controls were included. The groups had similar characteristics (sex, age, cancer, renal disease, chronic lung disease, hypertension, and incidence of venous thromboembolism [VTE]), except for somewhat higher rates of diabetes and heart failure among controls, and a higher rate of obesity among cases.
The investigators first looked at warfarin use among all knee and/or hip replacement cases and controls and calculated an odds ratio of 1.57 (95% confidence interval [CI], 1.30-1.89) for knee and hip replacement with warfarin after adjustment for body mass index, factors influencing choice of anticoagulant, comorbidities, other medications, general practitioner visits, and hospitalizations.
The association between warfarin and joint replacement held up in an analysis restricted to knee replacement only, with an adjusted OR of 1.48 (95% CI, 1.16-1.89).
There was also a clear association between duration of warfarin use and risk of knee and hip replacement.
“This abstract suggests the role of adequate vitamin K may be important in decreasing progression of osteoarthritis, which would then favor patients with OA who are on warfarin to consider changing to a DOAC; however, further studies are needed to confirm this finding and consider its impact on VTE and wound healing postop,” said Minna Kohler, MD, director of the rheumatology musculoskeletal ultrasound program at Massachusetts General Hospital in Boston. Dr. Kohler, who was not involved in the study, replied to an email request for comment.
The study was supported by grants from the National Institutes of Health. Dr. Ballal and Dr. Kohler reported having no conflicts of interest to disclose.
SOURCE: Ballal P et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0934.
FROM ACR 2020
Orthopedic problems in children can be the first indication of acute lymphoblastic leukemia
The diagnosis of acute lymphoblastic leukemia (ALL) can be delayed because of vague presentation and normal hematological results. Orthopedic manifestations may be the primary presentation of ALL to physicians, and such symptoms in children should be cause for suspicion, even in the absence of hematological abnormalities, according to a report published in the Journal of Orthopaedics.
The study retrospectively assessed 250 consecutive ALL patients at a single institution to identify the frequency of ALL cases presented to the orthopedic department and to determine the number of these patients presenting with normal hematological results, according to Amrath Raj BK, MD, and colleagues at the Manipal (India) Academy of Higher Education.
Suspicion warranted
Twenty-two of the 250 patients (8.8%) presented primarily to the orthopedic department (4 with vertebral compression fractures, 12 with joint pain, and 6 with bone pain), but were subsequently diagnosed with ALL. These results were comparable to previous studies. The mean patient age at the first visit was 5.6 years; 13 patients were boys, and 9 were girls. Six of these 22 patients (27.3%) had a normal peripheral blood smear, according to the researchers.
“Acute leukemia should be considered strongly as a differential diagnosis in children with severe osteoporosis and vertebral fractures. Initial orthopedic manifestations are not uncommon, and the primary physician should maintain a high index of suspicion as a peripheral smear is not diagnostic in all patients,” the researchers concluded.
The authors reported that there was no outside funding source and that they had no conflicts.
SOURCE: Raj BK A et al. Journal of Orthopaedics. 2020;22:326-330.
The diagnosis of acute lymphoblastic leukemia (ALL) can be delayed because of vague presentation and normal hematological results. Orthopedic manifestations may be the primary presentation of ALL to physicians, and such symptoms in children should be cause for suspicion, even in the absence of hematological abnormalities, according to a report published in the Journal of Orthopaedics.
The study retrospectively assessed 250 consecutive ALL patients at a single institution to identify the frequency of ALL cases presented to the orthopedic department and to determine the number of these patients presenting with normal hematological results, according to Amrath Raj BK, MD, and colleagues at the Manipal (India) Academy of Higher Education.
Suspicion warranted
Twenty-two of the 250 patients (8.8%) presented primarily to the orthopedic department (4 with vertebral compression fractures, 12 with joint pain, and 6 with bone pain), but were subsequently diagnosed with ALL. These results were comparable to previous studies. The mean patient age at the first visit was 5.6 years; 13 patients were boys, and 9 were girls. Six of these 22 patients (27.3%) had a normal peripheral blood smear, according to the researchers.
“Acute leukemia should be considered strongly as a differential diagnosis in children with severe osteoporosis and vertebral fractures. Initial orthopedic manifestations are not uncommon, and the primary physician should maintain a high index of suspicion as a peripheral smear is not diagnostic in all patients,” the researchers concluded.
The authors reported that there was no outside funding source and that they had no conflicts.
SOURCE: Raj BK A et al. Journal of Orthopaedics. 2020;22:326-330.
The diagnosis of acute lymphoblastic leukemia (ALL) can be delayed because of vague presentation and normal hematological results. Orthopedic manifestations may be the primary presentation of ALL to physicians, and such symptoms in children should be cause for suspicion, even in the absence of hematological abnormalities, according to a report published in the Journal of Orthopaedics.
The study retrospectively assessed 250 consecutive ALL patients at a single institution to identify the frequency of ALL cases presented to the orthopedic department and to determine the number of these patients presenting with normal hematological results, according to Amrath Raj BK, MD, and colleagues at the Manipal (India) Academy of Higher Education.
Suspicion warranted
Twenty-two of the 250 patients (8.8%) presented primarily to the orthopedic department (4 with vertebral compression fractures, 12 with joint pain, and 6 with bone pain), but were subsequently diagnosed with ALL. These results were comparable to previous studies. The mean patient age at the first visit was 5.6 years; 13 patients were boys, and 9 were girls. Six of these 22 patients (27.3%) had a normal peripheral blood smear, according to the researchers.
“Acute leukemia should be considered strongly as a differential diagnosis in children with severe osteoporosis and vertebral fractures. Initial orthopedic manifestations are not uncommon, and the primary physician should maintain a high index of suspicion as a peripheral smear is not diagnostic in all patients,” the researchers concluded.
The authors reported that there was no outside funding source and that they had no conflicts.
SOURCE: Raj BK A et al. Journal of Orthopaedics. 2020;22:326-330.
FROM THE JOURNAL OF ORTHOPAEDICS
New acute pain guidelines from the ACP and AAFP have limitations
The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting.
According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.
In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).
The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.
Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.
When physical therapy is needed
Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.
Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.
Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
How pain affects mental health
Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.
Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.
Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.
They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.
We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.
SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.
The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting.
According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.
In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).
The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.
Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.
When physical therapy is needed
Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.
Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.
Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
How pain affects mental health
Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.
Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.
Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.
They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.
We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.
SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.
The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting.
According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.
In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).
The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.
Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.
When physical therapy is needed
Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.
Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.
Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
How pain affects mental health
Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.
Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.
Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.
They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.
We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.
SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.
Diffuse idiopathic skeletal hyperostosis heart risk higher than expected
More people with diffuse idiopathic skeletal hyperostosis (DISH) develop cardiovascular disease (CVD) than is predicted by the Framingham Risk Score, results of an observational study have shown.
Notably, a higher rate of myocardial infarction (MI) was seen in those with DISH than in those without DISH over the 10-year follow-up period (24.4% vs. 4.3%; P = .0055).
“We propose more scrutiny is warranted in evaluating CV risk in these patients, more demanding treatment target goals should be established, and as a result, earlier and more aggressive preventive medical interventions instituted,” corresponding author Reuven Mader, MD, and associates wrote in Arthritis Research & Therapy.
“What Mader’s study is pointing out is that it’s worth the radiologist reporting [DISH],” Elizabeth A. Regan, MD, PhD, from the National Jewish Health Center in Denver, said in an interview.
DISH on a chest x-ray or CT scan should be another “red flag to be even more attentive to cardiovascular risk,” she added, particularly because studies have shown that people with DISH tend to be obese, have metabolic syndrome, or diabetes – all of which independently increase their risk for cardiovascular disease.
An old condition often found by accident
Physicians have known about DISH for many years, Dr. Mader of Ha’Emek Medical Center in Afula, Israel, observed in an interview. Historical evidence suggests it was present more than a thousand years ago, but it wasn’t until the 1950s that it gained scientific interest. Originally coined Forestier’s disease, it was renamed DISH in the late 1960s following the realization that it was not limited to the spine.
“It is a condition which is characterized by new bone formation,” Dr. Mader explained. This new bone formation has some predilection for the entheses – the tendons, ligaments, or joint capsules, that attach to the bone.
“Diagnosis of the disease is based mainly on radiographs, especially of the thoracic spine, and it requires the formation of bridges that connect at least four contiguous vertebra,” he continued.
“The bridges are usually right-sided and usually the intervertebral spaces are spared. Classically there is no involvement of the sacroiliac joints, although there are some changes that might involve the sacroiliac joints but in a different manner than in inflammatory sacroiliitis.”
DISH was originally thought to be a pain syndrome, which has “not played out,” Dr. Regan noted in her interview. While there may be people who experience pain as a result of DISH, most cases are asymptomatic and usually picked up incidentally on a chest x-ray or CT scan.
“It’s something that’s not obvious,” she said. One of the main problems it can cause is stiffness and lack of mobility in the spine and this can lead to quite severe fractures in some cases, such as during a car accident. Hence spinal surgeons and other orthopedic specialists, such as Dr. Regan, have also taken an interest in the condition.
“Apart from the thoracic spine, DISH may also involve the cervical spine; there have been many reports about difficulty in swallowing, breathing, and in the lumbar spine, spinal stenosis and so forth,” Dr. Mader said. The differential diagnosis includes ankylosing spondylitis, although there is some evidence that the two can coexist.
“The diagnosis depends on the alertness of the examining physician,” he added, noting that rheumatologists and other specialists would be “very aware of this condition” and “sensitive to changes that we see when we examine these patients.”
DISH and heightened cardiovascular risk
Previous work by Dr. Mader and associates has shown that people with DISH are more often affected by the metabolic syndrome than are those without DISH. The cross-sectional study had excluded those with preexisting CVD and found that people with DISH had a significantly higher Framingham Risk Score, compared with a control group of people with osteoarthritis and no DISH (P = .004), which in turn meant they had a significantly (P = .007) higher 10-year risk for developing CVD.
The aim of their most recent study was to compare the actual rate of CV events in 2016 versus those predicted by the Framingham Risk Score in 2006. To do this, they compared the available electronic medical records of 45 individuals with DISH and 47 without it.
The results showed that almost 39% of people with DISH had developed CVD, whereas the Framingham Risk Score had estimated that just under 27% would develop CVD.
For every 1% increase in the CVD risk calculated by the Framingham Risk Score, the odds of CVD increased by 4% in the DISH group versus the control group (P = .02).
While there was a significant (P < .003) difference in the Framingham Risk Score between the DISH and control groups in 2006 (28.6% vs. 17.8%), there was no overall statistical difference (P = .2) in the composite CVD outcome (38.8% vs. 25.5%) 10 years later, as calculated by the revised Framingham Risk Score, which included MI, cerebrovascular accident, transient ischemic attack, peripheral artery disease, and heart failure with preserved ejection fraction.
“We are dealing with patients who are in their 70s. So, it is expected that this group of patients will be more often affected by cardiovascular disease” than younger individuals, Dr. Mader observed. That said, the study’s findings “confirm the theory that patients with DISH have a high likelihood of developing cardiovascular disease,” he added, acknowledging that it was only the risk for MI that was statistically significantly higher in people with DISH than in the controls.
DISH and coronary artery calcification
“It might be even more interesting to have a different control population that had no osteoarthritis,” Dr. Regan observed.
As the associate director of the COPDGene study, Dr. Regan has access to data collected from a large cohort of people with chronic obstructive pulmonary disease (COPD; n = 2,728), around 13% of whom were identified as having DISH in one recent study.
In that study, the presence of DISH versus no DISH was associated with a 37% higher risk for having coronary artery calcification (CAC) – a marker for atherosclerosis and cardiovascular disease. Two-thirds of people with DISH had CAC, compared with 46.9% of those without DISH (P < .001). The prevalence of DISH was 8.8% in those without CAC, 12.8% in those with a CAC score of 1-100, 20% in those with a CAC score of 100-400, and 24.7% in those with a CAC score of more than 400, which is associated with a very high risk for coronary artery disease.
Dr. Regan observed that information on heart attacks and strokes were collected within the COPDGene study, so it would be possible to look at cardiovascular risk in their patients with DISH and confirm the findings of Mader and colleagues.
“I think the most important thing is recognizing that there are things going on in the spine that are important to people’s general health,” Dr. Regan said.
Dr. Mader noted: “It makes sense that patients with DISH should be more meticulously followed for at least the traditional risk factors and better treated because they are at a higher risk for these events.”
The study received no financial support. Neither Dr. Mader nor Dr. Regan had any conflicts of interest to disclose.
SOURCE: Glick K et al. Arthritis Res Ther. 2020. doi: 10.1186/s13075-020-02278-w.
More people with diffuse idiopathic skeletal hyperostosis (DISH) develop cardiovascular disease (CVD) than is predicted by the Framingham Risk Score, results of an observational study have shown.
Notably, a higher rate of myocardial infarction (MI) was seen in those with DISH than in those without DISH over the 10-year follow-up period (24.4% vs. 4.3%; P = .0055).
“We propose more scrutiny is warranted in evaluating CV risk in these patients, more demanding treatment target goals should be established, and as a result, earlier and more aggressive preventive medical interventions instituted,” corresponding author Reuven Mader, MD, and associates wrote in Arthritis Research & Therapy.
“What Mader’s study is pointing out is that it’s worth the radiologist reporting [DISH],” Elizabeth A. Regan, MD, PhD, from the National Jewish Health Center in Denver, said in an interview.
DISH on a chest x-ray or CT scan should be another “red flag to be even more attentive to cardiovascular risk,” she added, particularly because studies have shown that people with DISH tend to be obese, have metabolic syndrome, or diabetes – all of which independently increase their risk for cardiovascular disease.
An old condition often found by accident
Physicians have known about DISH for many years, Dr. Mader of Ha’Emek Medical Center in Afula, Israel, observed in an interview. Historical evidence suggests it was present more than a thousand years ago, but it wasn’t until the 1950s that it gained scientific interest. Originally coined Forestier’s disease, it was renamed DISH in the late 1960s following the realization that it was not limited to the spine.
“It is a condition which is characterized by new bone formation,” Dr. Mader explained. This new bone formation has some predilection for the entheses – the tendons, ligaments, or joint capsules, that attach to the bone.
“Diagnosis of the disease is based mainly on radiographs, especially of the thoracic spine, and it requires the formation of bridges that connect at least four contiguous vertebra,” he continued.
“The bridges are usually right-sided and usually the intervertebral spaces are spared. Classically there is no involvement of the sacroiliac joints, although there are some changes that might involve the sacroiliac joints but in a different manner than in inflammatory sacroiliitis.”
DISH was originally thought to be a pain syndrome, which has “not played out,” Dr. Regan noted in her interview. While there may be people who experience pain as a result of DISH, most cases are asymptomatic and usually picked up incidentally on a chest x-ray or CT scan.
“It’s something that’s not obvious,” she said. One of the main problems it can cause is stiffness and lack of mobility in the spine and this can lead to quite severe fractures in some cases, such as during a car accident. Hence spinal surgeons and other orthopedic specialists, such as Dr. Regan, have also taken an interest in the condition.
“Apart from the thoracic spine, DISH may also involve the cervical spine; there have been many reports about difficulty in swallowing, breathing, and in the lumbar spine, spinal stenosis and so forth,” Dr. Mader said. The differential diagnosis includes ankylosing spondylitis, although there is some evidence that the two can coexist.
“The diagnosis depends on the alertness of the examining physician,” he added, noting that rheumatologists and other specialists would be “very aware of this condition” and “sensitive to changes that we see when we examine these patients.”
DISH and heightened cardiovascular risk
Previous work by Dr. Mader and associates has shown that people with DISH are more often affected by the metabolic syndrome than are those without DISH. The cross-sectional study had excluded those with preexisting CVD and found that people with DISH had a significantly higher Framingham Risk Score, compared with a control group of people with osteoarthritis and no DISH (P = .004), which in turn meant they had a significantly (P = .007) higher 10-year risk for developing CVD.
The aim of their most recent study was to compare the actual rate of CV events in 2016 versus those predicted by the Framingham Risk Score in 2006. To do this, they compared the available electronic medical records of 45 individuals with DISH and 47 without it.
The results showed that almost 39% of people with DISH had developed CVD, whereas the Framingham Risk Score had estimated that just under 27% would develop CVD.
For every 1% increase in the CVD risk calculated by the Framingham Risk Score, the odds of CVD increased by 4% in the DISH group versus the control group (P = .02).
While there was a significant (P < .003) difference in the Framingham Risk Score between the DISH and control groups in 2006 (28.6% vs. 17.8%), there was no overall statistical difference (P = .2) in the composite CVD outcome (38.8% vs. 25.5%) 10 years later, as calculated by the revised Framingham Risk Score, which included MI, cerebrovascular accident, transient ischemic attack, peripheral artery disease, and heart failure with preserved ejection fraction.
“We are dealing with patients who are in their 70s. So, it is expected that this group of patients will be more often affected by cardiovascular disease” than younger individuals, Dr. Mader observed. That said, the study’s findings “confirm the theory that patients with DISH have a high likelihood of developing cardiovascular disease,” he added, acknowledging that it was only the risk for MI that was statistically significantly higher in people with DISH than in the controls.
DISH and coronary artery calcification
“It might be even more interesting to have a different control population that had no osteoarthritis,” Dr. Regan observed.
As the associate director of the COPDGene study, Dr. Regan has access to data collected from a large cohort of people with chronic obstructive pulmonary disease (COPD; n = 2,728), around 13% of whom were identified as having DISH in one recent study.
In that study, the presence of DISH versus no DISH was associated with a 37% higher risk for having coronary artery calcification (CAC) – a marker for atherosclerosis and cardiovascular disease. Two-thirds of people with DISH had CAC, compared with 46.9% of those without DISH (P < .001). The prevalence of DISH was 8.8% in those without CAC, 12.8% in those with a CAC score of 1-100, 20% in those with a CAC score of 100-400, and 24.7% in those with a CAC score of more than 400, which is associated with a very high risk for coronary artery disease.
Dr. Regan observed that information on heart attacks and strokes were collected within the COPDGene study, so it would be possible to look at cardiovascular risk in their patients with DISH and confirm the findings of Mader and colleagues.
“I think the most important thing is recognizing that there are things going on in the spine that are important to people’s general health,” Dr. Regan said.
Dr. Mader noted: “It makes sense that patients with DISH should be more meticulously followed for at least the traditional risk factors and better treated because they are at a higher risk for these events.”
The study received no financial support. Neither Dr. Mader nor Dr. Regan had any conflicts of interest to disclose.
SOURCE: Glick K et al. Arthritis Res Ther. 2020. doi: 10.1186/s13075-020-02278-w.
More people with diffuse idiopathic skeletal hyperostosis (DISH) develop cardiovascular disease (CVD) than is predicted by the Framingham Risk Score, results of an observational study have shown.
Notably, a higher rate of myocardial infarction (MI) was seen in those with DISH than in those without DISH over the 10-year follow-up period (24.4% vs. 4.3%; P = .0055).
“We propose more scrutiny is warranted in evaluating CV risk in these patients, more demanding treatment target goals should be established, and as a result, earlier and more aggressive preventive medical interventions instituted,” corresponding author Reuven Mader, MD, and associates wrote in Arthritis Research & Therapy.
“What Mader’s study is pointing out is that it’s worth the radiologist reporting [DISH],” Elizabeth A. Regan, MD, PhD, from the National Jewish Health Center in Denver, said in an interview.
DISH on a chest x-ray or CT scan should be another “red flag to be even more attentive to cardiovascular risk,” she added, particularly because studies have shown that people with DISH tend to be obese, have metabolic syndrome, or diabetes – all of which independently increase their risk for cardiovascular disease.
An old condition often found by accident
Physicians have known about DISH for many years, Dr. Mader of Ha’Emek Medical Center in Afula, Israel, observed in an interview. Historical evidence suggests it was present more than a thousand years ago, but it wasn’t until the 1950s that it gained scientific interest. Originally coined Forestier’s disease, it was renamed DISH in the late 1960s following the realization that it was not limited to the spine.
“It is a condition which is characterized by new bone formation,” Dr. Mader explained. This new bone formation has some predilection for the entheses – the tendons, ligaments, or joint capsules, that attach to the bone.
“Diagnosis of the disease is based mainly on radiographs, especially of the thoracic spine, and it requires the formation of bridges that connect at least four contiguous vertebra,” he continued.
“The bridges are usually right-sided and usually the intervertebral spaces are spared. Classically there is no involvement of the sacroiliac joints, although there are some changes that might involve the sacroiliac joints but in a different manner than in inflammatory sacroiliitis.”
DISH was originally thought to be a pain syndrome, which has “not played out,” Dr. Regan noted in her interview. While there may be people who experience pain as a result of DISH, most cases are asymptomatic and usually picked up incidentally on a chest x-ray or CT scan.
“It’s something that’s not obvious,” she said. One of the main problems it can cause is stiffness and lack of mobility in the spine and this can lead to quite severe fractures in some cases, such as during a car accident. Hence spinal surgeons and other orthopedic specialists, such as Dr. Regan, have also taken an interest in the condition.
“Apart from the thoracic spine, DISH may also involve the cervical spine; there have been many reports about difficulty in swallowing, breathing, and in the lumbar spine, spinal stenosis and so forth,” Dr. Mader said. The differential diagnosis includes ankylosing spondylitis, although there is some evidence that the two can coexist.
“The diagnosis depends on the alertness of the examining physician,” he added, noting that rheumatologists and other specialists would be “very aware of this condition” and “sensitive to changes that we see when we examine these patients.”
DISH and heightened cardiovascular risk
Previous work by Dr. Mader and associates has shown that people with DISH are more often affected by the metabolic syndrome than are those without DISH. The cross-sectional study had excluded those with preexisting CVD and found that people with DISH had a significantly higher Framingham Risk Score, compared with a control group of people with osteoarthritis and no DISH (P = .004), which in turn meant they had a significantly (P = .007) higher 10-year risk for developing CVD.
The aim of their most recent study was to compare the actual rate of CV events in 2016 versus those predicted by the Framingham Risk Score in 2006. To do this, they compared the available electronic medical records of 45 individuals with DISH and 47 without it.
The results showed that almost 39% of people with DISH had developed CVD, whereas the Framingham Risk Score had estimated that just under 27% would develop CVD.
For every 1% increase in the CVD risk calculated by the Framingham Risk Score, the odds of CVD increased by 4% in the DISH group versus the control group (P = .02).
While there was a significant (P < .003) difference in the Framingham Risk Score between the DISH and control groups in 2006 (28.6% vs. 17.8%), there was no overall statistical difference (P = .2) in the composite CVD outcome (38.8% vs. 25.5%) 10 years later, as calculated by the revised Framingham Risk Score, which included MI, cerebrovascular accident, transient ischemic attack, peripheral artery disease, and heart failure with preserved ejection fraction.
“We are dealing with patients who are in their 70s. So, it is expected that this group of patients will be more often affected by cardiovascular disease” than younger individuals, Dr. Mader observed. That said, the study’s findings “confirm the theory that patients with DISH have a high likelihood of developing cardiovascular disease,” he added, acknowledging that it was only the risk for MI that was statistically significantly higher in people with DISH than in the controls.
DISH and coronary artery calcification
“It might be even more interesting to have a different control population that had no osteoarthritis,” Dr. Regan observed.
As the associate director of the COPDGene study, Dr. Regan has access to data collected from a large cohort of people with chronic obstructive pulmonary disease (COPD; n = 2,728), around 13% of whom were identified as having DISH in one recent study.
In that study, the presence of DISH versus no DISH was associated with a 37% higher risk for having coronary artery calcification (CAC) – a marker for atherosclerosis and cardiovascular disease. Two-thirds of people with DISH had CAC, compared with 46.9% of those without DISH (P < .001). The prevalence of DISH was 8.8% in those without CAC, 12.8% in those with a CAC score of 1-100, 20% in those with a CAC score of 100-400, and 24.7% in those with a CAC score of more than 400, which is associated with a very high risk for coronary artery disease.
Dr. Regan observed that information on heart attacks and strokes were collected within the COPDGene study, so it would be possible to look at cardiovascular risk in their patients with DISH and confirm the findings of Mader and colleagues.
“I think the most important thing is recognizing that there are things going on in the spine that are important to people’s general health,” Dr. Regan said.
Dr. Mader noted: “It makes sense that patients with DISH should be more meticulously followed for at least the traditional risk factors and better treated because they are at a higher risk for these events.”
The study received no financial support. Neither Dr. Mader nor Dr. Regan had any conflicts of interest to disclose.
SOURCE: Glick K et al. Arthritis Res Ther. 2020. doi: 10.1186/s13075-020-02278-w.
FROM ARTHRITIS RESEARCH & THERAPY
Vitamin D pearls
Case: A 56-year-old man with a history of type 2 diabetes, hypertension, hyperlipidemia, and obesity calls clinic to discuss concerns about COVID-19, stating: “I want to do everything I can to reduce my risk of infection.” In addition to physical distancing, mask wearing, hand hygiene, and control of chronic conditions, which of the following supplements would you recommend for this patient?
1. Coenzyme Q10 160 mg twice a day
2. Vitamin D 2,000 IU daily
3. Vitamin E 400 IU daily
4. Vitamin B12 1,000 mcg daily
Of these choices, vitamin D supplementation is likely the best option, based on the limited data that is available.
Risk factors for worse COVID-19 outcome, such as older age, obesity, and more pigmented skin are also risk factors for vitamin D deficiency. This makes the study of vitamin D and COVID-19 both challenging and relevant.
In a recent study of 7,807 people living in Israel, Merzon and colleagues found that low plasma vitamin D level was an independent risk factor for COVID-19 infection. Mean plasma vitamin D level was significantly lower among those who tested positive for COVID-19 (19.00 ng/mL) than negative (20.55 ng/ mL). After controlling for demographic variables and several medical conditions, the adjusted odds ratio of COVID-19 infection in those with lower vitamin D was 1.45 (95% confidence interval, 1.08-1.95; P < .001). However, the odds of hospitalization for COVID-19 was not significantly associated with vitamin D level.1
Prior studies have also looked at vitamin D and respiratory infection. Martineau and colleagues analyzed 25 randomized, controlled trials with a pooled number of 11,321 individuals, including healthy ones and those with comorbidities, and found that oral vitamin D supplementation in daily or weekly doses had a protective effect against acute respiratory infection (adjusted odds ratio, 0.88; 95% CI, 0.81-0.96; P < .001). Patients with vitamin D deficiency (less than 25 nmol/L) experienced the most protective benefit. Vitamin D did not influence respiratory infection outcome.2
These studies suggest an adequate vitamin D level may be protective against infection with COVID-19, but who will benefit from vitamin D supplementation, and in what dose? Per U.S. Preventive Services Task Force guidelines, there is insufficient evidence to recommend screening for vitamin D deficiency in asymptomatic adults. Regarding daily dietary intake, the Institute of Medicine recommends 600 IU for persons aged 1-70, and 800 IU for those aged over 70 years. Salmon (447 IU per 3 oz serving), tuna (154 IU), and fortified milk (116 IU) are among the most vitamin D–rich foods.3 The recommended upper level of intake is 4,000 IU/day.
Too much of a good thing?
Extra vitamin D is stored in adipose tissue. If it builds up over time, storage sites may be overwhelmed, causing a rise in serum D level. While one might expect a subsequent rise in calcium levels, studies have shown this happens inconsistently, and at very high vitamin D levels, over 120 ng/mL.4 Most people would have to take at least 50,000 IU daily for several months to see an effect. The main adverse outcome of vitamin D toxicity is kidney stones, mediated by increased calcium in the blood and urine.
Several animal models have demonstrated hypervitaminosis D–induced aortic and coronary artery calcification. Like with kidney stones, the mechanism appears to be through increased calcium and phosphate levels. Shroff and colleagues studied serum vitamin D levels and vascular disease in children with renal disease on dialysis and found a U-shaped distribution: Children with both low and high vitamin D levels had significantly increased carotid artery intima-media thickness and calcification.5 Given the specialized nature of this population, it’s unclear whether these results can be generalized to most people. More studies are warranted on this topic.
Other benefits
Vitamin D is perhaps most famous for helping to build strong bones. Avenell and colleagues performed a Cochrane meta-analysis of vitamin D supplementation in older adults and found that vitamin D alone did not significantly reduce the risk of hip or other new fracture. Vitamin D plus calcium supplementation did reduce the risk of hip fracture (nine trials, pooled number of individuals was 49,853; relative risk, 0.84; P = .01).6
A lesser-known benefit of vitamin D is muscle protection. A prospective study out of the Jewish Hospital of Cincinnati followed 146 adults who were intolerant to two or more statins because of muscle side effects and found to have a vitamin D level below 32 ng per mL. Subjects were given vitamin D replacement (50,000 units weekly) and followed for 2 years. On statin rechallenge, 88-95% tolerated a statin with vitamin D levels 53-55 ng/mL.7
Pearl
Vitamin D supplementation may protect against COVID-19 infection and has very low chance of harm at daily doses at or below 4,000 IU. Other benefits of taking vitamin D include bone protection and reduction in statin-induced myopathy. The main adverse effect is kidney stones.
Ms. Sharninghausen is a medical student at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Merzon E et al. Low plasma 25(OH) vitamin D level is associated with increased risk of COVID‐19 infection: An Israeli population‐based study. FEBS J. 2020. doi: 10.1111/febs.15495.
2. Martineau AR et al. Vitamin D supplementation to prevent acute respiratory tract infections: Systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583. doi:10.1136/bmj.i6583
3. “How to Get More Vitamin D From Your Food,” Cleveland Clinic. 2019 Oct 23. https://health.clevelandclinic.org/how-to-get-more-vitamin-d-from-your-food/.
4. Galior K et al. Development of vitamin d toxicity from overcorrection of vitamin D Deficiency: A review of case reports. Nutrients. 2018;10(8):953. doi: 10.3390/nu10080953
5. Shroff R et al. A bimodal association of vitamin D levels and vascular disease in children on dialysis. J Am Soc Nephrol. 2008;19(6):1239-46. doi: 10.1681/ASN.2007090993.
6. Avenell A et al. Vitamin D and vitamin D analogues for preventing fractures in post‐menopausal women and older men. Cochrane Database Syst Rev. 2014 Apr 14;2014(4):CD000227. doi: 10.1002/14651858.CD000227.pub4.
7. Khayznikov M et al. Statin intolerance because of myalgia, myositis, myopathy, or myonecrosis can in most cases be safely resolved by vitamin D supplementation. N Am J Med Sci. 2015;7(3):86-93. doi:10.4103/1947-2714.153919
Case: A 56-year-old man with a history of type 2 diabetes, hypertension, hyperlipidemia, and obesity calls clinic to discuss concerns about COVID-19, stating: “I want to do everything I can to reduce my risk of infection.” In addition to physical distancing, mask wearing, hand hygiene, and control of chronic conditions, which of the following supplements would you recommend for this patient?
1. Coenzyme Q10 160 mg twice a day
2. Vitamin D 2,000 IU daily
3. Vitamin E 400 IU daily
4. Vitamin B12 1,000 mcg daily
Of these choices, vitamin D supplementation is likely the best option, based on the limited data that is available.
Risk factors for worse COVID-19 outcome, such as older age, obesity, and more pigmented skin are also risk factors for vitamin D deficiency. This makes the study of vitamin D and COVID-19 both challenging and relevant.
In a recent study of 7,807 people living in Israel, Merzon and colleagues found that low plasma vitamin D level was an independent risk factor for COVID-19 infection. Mean plasma vitamin D level was significantly lower among those who tested positive for COVID-19 (19.00 ng/mL) than negative (20.55 ng/ mL). After controlling for demographic variables and several medical conditions, the adjusted odds ratio of COVID-19 infection in those with lower vitamin D was 1.45 (95% confidence interval, 1.08-1.95; P < .001). However, the odds of hospitalization for COVID-19 was not significantly associated with vitamin D level.1
Prior studies have also looked at vitamin D and respiratory infection. Martineau and colleagues analyzed 25 randomized, controlled trials with a pooled number of 11,321 individuals, including healthy ones and those with comorbidities, and found that oral vitamin D supplementation in daily or weekly doses had a protective effect against acute respiratory infection (adjusted odds ratio, 0.88; 95% CI, 0.81-0.96; P < .001). Patients with vitamin D deficiency (less than 25 nmol/L) experienced the most protective benefit. Vitamin D did not influence respiratory infection outcome.2
These studies suggest an adequate vitamin D level may be protective against infection with COVID-19, but who will benefit from vitamin D supplementation, and in what dose? Per U.S. Preventive Services Task Force guidelines, there is insufficient evidence to recommend screening for vitamin D deficiency in asymptomatic adults. Regarding daily dietary intake, the Institute of Medicine recommends 600 IU for persons aged 1-70, and 800 IU for those aged over 70 years. Salmon (447 IU per 3 oz serving), tuna (154 IU), and fortified milk (116 IU) are among the most vitamin D–rich foods.3 The recommended upper level of intake is 4,000 IU/day.
Too much of a good thing?
Extra vitamin D is stored in adipose tissue. If it builds up over time, storage sites may be overwhelmed, causing a rise in serum D level. While one might expect a subsequent rise in calcium levels, studies have shown this happens inconsistently, and at very high vitamin D levels, over 120 ng/mL.4 Most people would have to take at least 50,000 IU daily for several months to see an effect. The main adverse outcome of vitamin D toxicity is kidney stones, mediated by increased calcium in the blood and urine.
Several animal models have demonstrated hypervitaminosis D–induced aortic and coronary artery calcification. Like with kidney stones, the mechanism appears to be through increased calcium and phosphate levels. Shroff and colleagues studied serum vitamin D levels and vascular disease in children with renal disease on dialysis and found a U-shaped distribution: Children with both low and high vitamin D levels had significantly increased carotid artery intima-media thickness and calcification.5 Given the specialized nature of this population, it’s unclear whether these results can be generalized to most people. More studies are warranted on this topic.
Other benefits
Vitamin D is perhaps most famous for helping to build strong bones. Avenell and colleagues performed a Cochrane meta-analysis of vitamin D supplementation in older adults and found that vitamin D alone did not significantly reduce the risk of hip or other new fracture. Vitamin D plus calcium supplementation did reduce the risk of hip fracture (nine trials, pooled number of individuals was 49,853; relative risk, 0.84; P = .01).6
A lesser-known benefit of vitamin D is muscle protection. A prospective study out of the Jewish Hospital of Cincinnati followed 146 adults who were intolerant to two or more statins because of muscle side effects and found to have a vitamin D level below 32 ng per mL. Subjects were given vitamin D replacement (50,000 units weekly) and followed for 2 years. On statin rechallenge, 88-95% tolerated a statin with vitamin D levels 53-55 ng/mL.7
Pearl
Vitamin D supplementation may protect against COVID-19 infection and has very low chance of harm at daily doses at or below 4,000 IU. Other benefits of taking vitamin D include bone protection and reduction in statin-induced myopathy. The main adverse effect is kidney stones.
Ms. Sharninghausen is a medical student at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Merzon E et al. Low plasma 25(OH) vitamin D level is associated with increased risk of COVID‐19 infection: An Israeli population‐based study. FEBS J. 2020. doi: 10.1111/febs.15495.
2. Martineau AR et al. Vitamin D supplementation to prevent acute respiratory tract infections: Systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583. doi:10.1136/bmj.i6583
3. “How to Get More Vitamin D From Your Food,” Cleveland Clinic. 2019 Oct 23. https://health.clevelandclinic.org/how-to-get-more-vitamin-d-from-your-food/.
4. Galior K et al. Development of vitamin d toxicity from overcorrection of vitamin D Deficiency: A review of case reports. Nutrients. 2018;10(8):953. doi: 10.3390/nu10080953
5. Shroff R et al. A bimodal association of vitamin D levels and vascular disease in children on dialysis. J Am Soc Nephrol. 2008;19(6):1239-46. doi: 10.1681/ASN.2007090993.
6. Avenell A et al. Vitamin D and vitamin D analogues for preventing fractures in post‐menopausal women and older men. Cochrane Database Syst Rev. 2014 Apr 14;2014(4):CD000227. doi: 10.1002/14651858.CD000227.pub4.
7. Khayznikov M et al. Statin intolerance because of myalgia, myositis, myopathy, or myonecrosis can in most cases be safely resolved by vitamin D supplementation. N Am J Med Sci. 2015;7(3):86-93. doi:10.4103/1947-2714.153919
Case: A 56-year-old man with a history of type 2 diabetes, hypertension, hyperlipidemia, and obesity calls clinic to discuss concerns about COVID-19, stating: “I want to do everything I can to reduce my risk of infection.” In addition to physical distancing, mask wearing, hand hygiene, and control of chronic conditions, which of the following supplements would you recommend for this patient?
1. Coenzyme Q10 160 mg twice a day
2. Vitamin D 2,000 IU daily
3. Vitamin E 400 IU daily
4. Vitamin B12 1,000 mcg daily
Of these choices, vitamin D supplementation is likely the best option, based on the limited data that is available.
Risk factors for worse COVID-19 outcome, such as older age, obesity, and more pigmented skin are also risk factors for vitamin D deficiency. This makes the study of vitamin D and COVID-19 both challenging and relevant.
In a recent study of 7,807 people living in Israel, Merzon and colleagues found that low plasma vitamin D level was an independent risk factor for COVID-19 infection. Mean plasma vitamin D level was significantly lower among those who tested positive for COVID-19 (19.00 ng/mL) than negative (20.55 ng/ mL). After controlling for demographic variables and several medical conditions, the adjusted odds ratio of COVID-19 infection in those with lower vitamin D was 1.45 (95% confidence interval, 1.08-1.95; P < .001). However, the odds of hospitalization for COVID-19 was not significantly associated with vitamin D level.1
Prior studies have also looked at vitamin D and respiratory infection. Martineau and colleagues analyzed 25 randomized, controlled trials with a pooled number of 11,321 individuals, including healthy ones and those with comorbidities, and found that oral vitamin D supplementation in daily or weekly doses had a protective effect against acute respiratory infection (adjusted odds ratio, 0.88; 95% CI, 0.81-0.96; P < .001). Patients with vitamin D deficiency (less than 25 nmol/L) experienced the most protective benefit. Vitamin D did not influence respiratory infection outcome.2
These studies suggest an adequate vitamin D level may be protective against infection with COVID-19, but who will benefit from vitamin D supplementation, and in what dose? Per U.S. Preventive Services Task Force guidelines, there is insufficient evidence to recommend screening for vitamin D deficiency in asymptomatic adults. Regarding daily dietary intake, the Institute of Medicine recommends 600 IU for persons aged 1-70, and 800 IU for those aged over 70 years. Salmon (447 IU per 3 oz serving), tuna (154 IU), and fortified milk (116 IU) are among the most vitamin D–rich foods.3 The recommended upper level of intake is 4,000 IU/day.
Too much of a good thing?
Extra vitamin D is stored in adipose tissue. If it builds up over time, storage sites may be overwhelmed, causing a rise in serum D level. While one might expect a subsequent rise in calcium levels, studies have shown this happens inconsistently, and at very high vitamin D levels, over 120 ng/mL.4 Most people would have to take at least 50,000 IU daily for several months to see an effect. The main adverse outcome of vitamin D toxicity is kidney stones, mediated by increased calcium in the blood and urine.
Several animal models have demonstrated hypervitaminosis D–induced aortic and coronary artery calcification. Like with kidney stones, the mechanism appears to be through increased calcium and phosphate levels. Shroff and colleagues studied serum vitamin D levels and vascular disease in children with renal disease on dialysis and found a U-shaped distribution: Children with both low and high vitamin D levels had significantly increased carotid artery intima-media thickness and calcification.5 Given the specialized nature of this population, it’s unclear whether these results can be generalized to most people. More studies are warranted on this topic.
Other benefits
Vitamin D is perhaps most famous for helping to build strong bones. Avenell and colleagues performed a Cochrane meta-analysis of vitamin D supplementation in older adults and found that vitamin D alone did not significantly reduce the risk of hip or other new fracture. Vitamin D plus calcium supplementation did reduce the risk of hip fracture (nine trials, pooled number of individuals was 49,853; relative risk, 0.84; P = .01).6
A lesser-known benefit of vitamin D is muscle protection. A prospective study out of the Jewish Hospital of Cincinnati followed 146 adults who were intolerant to two or more statins because of muscle side effects and found to have a vitamin D level below 32 ng per mL. Subjects were given vitamin D replacement (50,000 units weekly) and followed for 2 years. On statin rechallenge, 88-95% tolerated a statin with vitamin D levels 53-55 ng/mL.7
Pearl
Vitamin D supplementation may protect against COVID-19 infection and has very low chance of harm at daily doses at or below 4,000 IU. Other benefits of taking vitamin D include bone protection and reduction in statin-induced myopathy. The main adverse effect is kidney stones.
Ms. Sharninghausen is a medical student at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Merzon E et al. Low plasma 25(OH) vitamin D level is associated with increased risk of COVID‐19 infection: An Israeli population‐based study. FEBS J. 2020. doi: 10.1111/febs.15495.
2. Martineau AR et al. Vitamin D supplementation to prevent acute respiratory tract infections: Systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583. doi:10.1136/bmj.i6583
3. “How to Get More Vitamin D From Your Food,” Cleveland Clinic. 2019 Oct 23. https://health.clevelandclinic.org/how-to-get-more-vitamin-d-from-your-food/.
4. Galior K et al. Development of vitamin d toxicity from overcorrection of vitamin D Deficiency: A review of case reports. Nutrients. 2018;10(8):953. doi: 10.3390/nu10080953
5. Shroff R et al. A bimodal association of vitamin D levels and vascular disease in children on dialysis. J Am Soc Nephrol. 2008;19(6):1239-46. doi: 10.1681/ASN.2007090993.
6. Avenell A et al. Vitamin D and vitamin D analogues for preventing fractures in post‐menopausal women and older men. Cochrane Database Syst Rev. 2014 Apr 14;2014(4):CD000227. doi: 10.1002/14651858.CD000227.pub4.
7. Khayznikov M et al. Statin intolerance because of myalgia, myositis, myopathy, or myonecrosis can in most cases be safely resolved by vitamin D supplementation. N Am J Med Sci. 2015;7(3):86-93. doi:10.4103/1947-2714.153919
Ten-Year Outcomes of a Systems-Based Approach to Longitudinal Amputation Care in the US Department of Veteran Affairs
The US Department of Veterans Affairs (VA) established a formal Amputation System of Care (ASoC) in 2008 with the goal of enhancing the quality and consistency of amputation rehabilitation care for veterans with limb loss.1,2 Throughout its history, the VA has placed a high priority on the care that is provided to veterans with limb amputation.1,3 Amputations have medical, physical, social, and psychological ramifications for the veteran and his or her family. Therefore, management of veterans with limb loss requires a comprehensive, coordinated, transdisciplinary program of services throughout the continuum of care. This includes offering the latest practices in medical interventions, artificial limbs, assistive technologies, and rehabilitation strategies to restore function and thereby optimize quality of life.
Amputation System of Care
The ASoC is an integrated system within the Veterans Health Administration (VHA) that provides specialized expertise in amputation rehabilitation incorporating the latest practices in medical management, rehabilitation therapies, artificial limbs, and assistive technologies. The system facilitates patient-centered, gender-sensitive, lifelong care and care coordination across the entire health continuum from acute inpatient hospitalization through a spectrum of inpatient, residential, and outpatient rehabilitation care settings. Through the provision of quality rehabilitation and prosthetic limb care, the ASoC strives to minimize disability and enable the highest level of social, vocational, and recreational success for veterans with an amputation.1-3
The policy and procedures for the ASoC have been detailed in prior VA Handbooks and in the ASoC Directive.1 This article highlights the background, population served, and organizational structure of the ASoC by detailing the outcomes and accomplishments of this systems-based approach to longitudinal amputation care between 2009 and 2019. Four core areas of activities and accomplishments are highlighted: (1) learning organization creation; (2) trust in VA care; (3) system modernization; and (4) customer service. This analysis and description of the VA amputation care program serves as a model of amputation care that can be used in the civilian sector. There also is potential for the ASoC to serve as a care model example for other populations within the VA.
Organizational Structure
The ASoC is an integrated, national health care delivery system in which each VA medical center (VAMC) has a specific designation that reflects the level of expertise and accessibility across the system based on an individual veteran’s needs and the specific capabilities of each VAMC.1-3 The organizational structure for the ASoC is similar to the Polytrauma System of Care in that facilities are divided into 4 tiers.1,4
For the ASoC, the 4 tiers are Regional Amputation Centers (RAC) at 7 VAMCs, Polytrauma Amputation Network Sites (PANS) at 18 VAMCs, Amputation Clinic Teams (ACT) at 106 VAMCs, and Amputation Points of Contact (APoC) at 22 VAMCs. The RAC locations provide the highest level of specialized expertise in clinical care and prosthetic limb technology and have rehabilitation capabilities to manage the most complicated cases. Like the RAC facilities, PANS provide a full range of clinical and ancillary services to veterans within their catchment area and serve as referral locations for veterans with needs that are more complex. ACT sites have a core amputation specialty team that provides regular follow-up and address ongoing care needs. ACT sites may or may not have full ancillary services, such as surgical subspecialties or an in-house prosthetics laboratory. APoC facilities have at least 1 person on staff who serves as the point of contact for consultation, assessment, and referral of a veteran with an amputation to a facility capable of providing the level of services required.1
The VA also places a high priority on both primary and secondary amputation prevention. The Preventing Amputations in Veterans Everywhere (PAVE) program and the ASoC coordinate efforts in order to address the prevention of an initial amputation, the rehabilitation of veterans who have had an amputation, and the prevention of a second amputation in those with an amputation.1,5
Population Served
The ASoC serves veterans with limb loss regardless of the etiology. This includes care of individuals with complex limb trauma and those with other injuries or disease processes resulting in a high likelihood of requiring a limb amputation. In 2019, the VA provided care to 96,519 veterans with amputation, and about half (46,214) had at least 1 major limb amputation, which is defined as an amputation at or proximal to the wrist or ankle.6 The majority of veterans with amputation treated within the VA have limb loss resulting from disease processes, such as diabetes mellitus (DM) and peripheral vascular disease (PVD). Amputations caused by these diseases generally occur in the older veteran population and are associated with comorbidities, such as cardiovascular disease, hypertension, and end-stage renal disease. Veterans with amputation due to trauma, including conflict-related injuries, are commonly younger at the time of their amputation. Although the number of conflict-related amputations is small compared with the number of amputations associated with disease processes, both groups require high-quality, comprehensive, lifelong care.
Between 2009 and 2019, the number of veterans with limb loss receiving care in the VA increased 34%.6 With advances in vascular surgery and limb-sparing procedures, minor amputations are more common than major limb amputations and more below-knee rather than above-knee amputations have been noted over the same time. However, the high prevalence of DM in the overall veteran population places about 1.8 million veterans at risk for amputation, and it is anticipated that the volume of limb loss in the veteran population will continue to grow and possibly accelerate.5
Performance Metrics
During this same period, the amputation specialty clinic encounter to unique ratio (a measure of how frequently patients return to the clinic each year) rose from 1.8 in 2009 to 2.3 in 2019 for both the total amputation population and for those with major limb amputation. When looking more specifically at the RAC facilities, the encounter to unique ratio increased from 1.5 to 3.0 over the same time, reflecting the added benefit of having dedicated resources for the amputation specialty program.6
Comparing the percentage of veterans with amputation who are seen in the VA for any service with those who also are seen in the amputation specialty clinic in the same year is a performance metric that reflects the penetration of amputation specialty services across the system. Between 2009 and 2019, this increased from 2.9 to 12.7% for the overall amputation population and from 4.8 to 26% for those with major limb amputation (Figure 2). This metric improved to a greater extent in RAC facilities; 44% of veterans with major limb amputation seen at a RAC were also seen in the amputation specialty clinic in 2019.6
System Hallmarks
One of the primary hallmarks of the ASoC is the interdisciplinary team approach addressing all aspects of management across the continuum of care (Table). The core team consists of a physician, therapist, and prosthetist, and may include a variety of other disciplines based on a veteran’s individual needs. This model promotes veteran-centric care. Comprehensive management of veterans with limb loss includes addressing medical considerations such as residual limb skin health to the prescription of artificial limbs and the provision of therapy services for prosthetic limb gait training.1,2
Lifelong care for veterans living with limb loss is another hallmark of the ASoC. The provision of care coordination across the continuum of care from acute hospitalization following an amputation to long-term follow-up in the outpatient setting for veteran’s lifespan is essential. Care coordination is provided across the system of care, which assures that a veteran with limb loss can obtain the required services through consultation or referral to a RAC or PANS as needed. Care coordination for the ASoC is facilitated by amputation rehabilitation coordinators at each of the RAC and PANS designated VAMCs.
Integration of services and resource collaboration are additional key aspects of the ASoC (Figure 3). In order to be successful, care of the veteran facing potential amputation or living with the challenges postamputation must be well-integrated into the broader care of the individual. Many veterans who undergo amputation have significant medical comorbidities, including a high prevalence of DM and peripheral vascular disease. Management of these conditions in collaboration with primary care and other medical specialties promotes the achievement of rehabilitation goals. Integration of surgical services and amputation prevention strategies is critical. Another essential element of the system is maintaining amputation specialty care team contact with all veterans with limb loss on at least an annual basis. A clinical practice guideline published in 2017 on lower Limb amputation rehabilitation emphasizes this need for an annual contact and includes a management and referral algorithm to assist primary care providers in the management of veterans with amputation (Figure 4).7
Collaboration with external partners has been an important element in the system of care development. The VA has partnered extensively with the US Department of Defense (DoD) to transition service members with amputation from the military health care system to the VA. The VA and DoD also have collaborated through the development and provision of joint provider trainings, clinical practice guidelines, incentive funding programs, and patient education materials. Congress authorized the Extremity Trauma and Amputation Center of Excellence (EACE) in 2009 with the mission to serve as the joint DoD and VA lead element focused on the mitigation, treatment, and rehabilitation of traumatic extremity injuries and amputations. The EACE has several lines of effort, including clinical affairs, research, and global outreach focused on building partnerships and fostering collaboration to optimize quality of life for those with extremity trauma and amputation. The Amputee Coalition, the largest nonprofit consumer-based amputee advocacy organization in the US, has been an important strategic partner for the dissemination of guideline recommendations and patient education as well as the development and provision of peer support services.
Methods
The ASoC created a learning organization to develop and maintain a knowledgeable and highly skilled clinical workforce through the identification of best practices related to amputation rehabilitation and the use of innovative education delivery models. During the past 10 years, the ASoC conducted 9 national, live health care provider training events in conjunction with the DoD. In conjunction with the EACE, the ASoC holds 6 national Grand Rounds sessions each year. Dissemination of information and trainings across both the VA and DoD has been facilitated through a national listserv referred to as the Federal Amputation Interest Group (FAIG), which has > 800 members. Since 2009, the VA, in collaboration with the DoD, has produced 3 clinical practice guidelines (CPGs) related to amputation care. The Lower Limb Amputation CPG was published in 2007 and updated in 2017, and a CPG and associated clinician resources focused on upper extremity amputation were published in 2014.7,8 In addition to these formal, comprehensive, and evidence-driven guidelines, the ASoC has developed other clinical support documents covering a range of topics from prosthesis prescription candidacy determination to osseointegration. In conjunction with the EACE, The ASoC also has published guidance for clinical implementation of new technologies such as the Mobius Bionics LUKE arm and Dynamic Response Ankle-Foot Orthoses.
The ASoC strives to improve the psychosocial welfare of veterans with amputation and enhance trust in VA amputation care services through sharing results on the quality and timeliness of care. The Commission on Accreditation for Rehabilitation Facilities (CARF) provides an international, independent, peer-reviewed system of accreditation that is widely recognized by federal agencies, state governments, major insurers, and professional organizations.1,2 CARF offers amputation specialty accreditation for inpatient and outpatient programs that signifies the attainment of a distinguished level of expertise and the provision of a comprehensive spectrum of services related to amputation care and rehabilitation. During its development, the ASoC established the expectation that each of the RAC and PANS designated VAMCs would attain and maintain CARF amputation specialty accreditation. The ASoC has achieved 100% success on this metric.
In addition, the ASoC has completed many other initiatives focused on enhancing trust in VA amputation care services. These include assuring compliance with implementation of the Mission Act as it relates to the provision of amputation care and prosthetic limb delivery so that any services provided in the community are well integrated and at the direction of the amputation specialty team. The ASoC has maintained a strong relationship with the Amputee Coalition to provide veterans with high-quality patient education materials as well as integrated peer support services.
ASoC virtual and face-to-face training events incorporate suicide prevention training for providers. Special focus has been placed on care provision for Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn veterans with conflict-related multiple limb amputations. Although relatively small, this cohort is recognized as a unique and important population due to their unique care needs and increased risk for secondary complications. In 2019, 83% of these individuals were contacted to assure their amputation care needs were being adequately addressed.
Discussion
Over the past 10 years, the ASoC has built a modern, high-performance network of care to best serve veterans with amputation. Maturation of the system has included the addition of 3 new PANS locations to improve access to services as well as to better support geographic regions near large DoD military treatment facilities. The number of ACT designated VAMCs also has grown from 101 to 106 locations. The regional organization of sites has been modified to enhance the availability of referral and consultative services across the system. In addition, the ASoC has supported the development of an upper extremity amputation specialty program for consultation or referral to a highly specialized team of providers well versed in the significant technology advances that have taken place with upper extremity prostheses.9
One of the key components to high-performance network development is attaining a clear picture of the clinical demands and service delivery needs of the population served. The Amputee Data Repository was developed with the support of the VHA Support Service Center (VSSC) in order to better understand and track the population of veterans with amputation.6 The development and implementation of the Amputee Data Repository took place over several years, and the product was officially released into publication in 2015. The overall goals of this resource are to provide a data system for the ASoC to identify clinical care volumes and patterns of treatment; better understand the demographics of the veteran amputee population; assess the effectiveness of new treatment strategies; and utilize data analysis outcomes to influence clinical practice. The acquisition and analysis of this information will provide justification for the modification of clinical practice and will enhance the quality of care for all veterans with amputation.
Although the ASoC focuses primarily on the provision of clinical services, the system has been leveraged to support research activities and the advancement of artificial limb technologies. For example, ASoC providers and investigators supported the clinical research required to test and optimize the development of the DEKA arm. These research efforts resulted in the US Food and Drug Administration approval and commercialization of this device. Once the device became commercially available as the LUKE arm, the ASoC developed a clinical implementation strategy that assured availability and appropriate prescription and training with the new technology. The VA also has supported research and program development in osseointegration with further investigations and clinical implementation being planned.
Telehealth
The goal of the ASoC is to provide timely access and greater choice to specialty amputation rehabilitation services for veterans as determined by their clinical needs. One key strategy used to achieve this goal has been the expansion of virtual communication tools to enhance access to clinical expertise. Telehealth (Virtual Care) amputation services afford the opportunity to provide specialized clinical expertise to veterans who otherwise may not have access to this level of service or consultation.1,2 For others, virtual care services reduce the need for travel. The ASoC has leveraged these services effectively to enhance specialty amputation care for veterans in rural areas. Over time, the scope of virtual care services has expanded to provide virtual peer support services as well as care in the veteran’s home.
Another unique example is the use of virtual care to see veterans when they are being provided services by a community prosthetist. This service improves the timeliness of care and reduces the travel burden for the veteran. Between 2009 and 2019, total virtual care encounters to provide amputation-related services grew from 44 encounters to 3,905 encounters (Figure 5). In 2019, 13.8% of veterans seen in a VA outpatient amputation specialty clinic had at least 1 virtual encounter in the same year.6
In addition to the expansion of virtual care and building capacity through increasing the number of amputation specialty clinics and providers, the ASoC has used a host of other strategies to improve care access. The development of provider expertise in amputation care has been achieved through the methods of extensive provider training. Implementation of Patient Self-Referral Direct Scheduling allows veterans to access the outpatient amputation specialty clinic without a referral and without having to be seen by their primary care provider. This initiative provides easier and more timely access to amputation specialty services while reducing burden on primary care services. The amputation outpatient specialty clinic was one of a few specialty programs to be an early adopter of national online scheduling. The implementation of this service is still ongoing, but this program gives veterans greater control over scheduling, canceling, and rescheduling appointments.
Conclusions
During the 10 years following its implementation, the VA ASoC has successfully enhanced the quality and consistency of care and rehabilitation services provided to veterans with limb loss through the provision of highly specialized services in the areas of medical care, rehabilitation services, and prosthetic technology. This mission has been accomplished through prioritization and implementation of key strategic initiatives in learning organization creation, trust in VA care, development of a modern, high-performance network, and customer service. Collaborative partnerships both internally within the VA and externally with key stakeholders has facilitated this development, and these will need to be enhanced for future success. Evolving trends in amputation surgery, limb transplantation, artificial limb control and suspension strategies as well as advances in assistive technology also will need to be integrated into best practices and program development.
1. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1172.03(1): Amputation system of care. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7482. Published August 3, 2018. Accessed July 31, 2020.
2. Webster JB, Poorman CE, Cifu DX. Guest editorial: Department of Veterans Affairs Amputations System of care: 5 years of accomplishments and outcomes. J Rehabil Res Dev. 2014;51(4):vii-xvi. doi:10.1682/JRRD.2014.01.0024
3. Reiber GE, Smith DG. VA paradigm shift in care of veterans with limb loss. J Rehabil Res Dev. 2010;47(4):vii-x. doi:10.1682/jrrd.2010.03.0030
4. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1172.01: Polytrauma system of care. https://www.va.gov/OPTOMETRY/docs/VHA_Directive_1172-01_Polytrauma_System_of_Care_1172_01_D_2019-01-24.pdf. Published January 24, 2019. Accessed July 31, 2020.
5. VHA Directive 1410, Prevention of amputation in veterans everywhere (PAVE) program, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5364. Published March 31, 2017. Accessed July 31, 2020.
6. VHA Amputee Data Repository. VHA Support Service Center. http://vssc.med.va.gov. [Nonpublic source, not verified.]
7. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: rehabilitation of lower limb amputation. Version 2.0 -2017. https://www.healthquality.va.gov/guidelines/Rehab/amp/VADoDLLACPG092817.pdf. Accessed July 16, 2020.
8. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: The Management of upper extremity amputation rehabilitation.Version 1-2014. https://www.healthquality.va.gov/guidelines/Rehab/UEAR/VADoDCPGManagementofUEAR121614Corrected508.pdf. Accessed July 16, 2020.
9. Resnik L, Meucci MR, Lieberman-Klinger S, et al. Advanced upper limb prosthetic devices: implications for upper limb prosthetic rehabilitation. Arch Phys Med Rehabil. 2012;93(4):710-717. doi:10.1016/j.apmr.2011.11.010
10. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: rehabilitation of lower limb amputation. Version 2.0 -2017. Pocket card. https://www.healthquality.va.gov/guidelines/Rehab/amp/VADoDLLACPGPocketCard092817.pdf. Accessed July 31, 2020.
The US Department of Veterans Affairs (VA) established a formal Amputation System of Care (ASoC) in 2008 with the goal of enhancing the quality and consistency of amputation rehabilitation care for veterans with limb loss.1,2 Throughout its history, the VA has placed a high priority on the care that is provided to veterans with limb amputation.1,3 Amputations have medical, physical, social, and psychological ramifications for the veteran and his or her family. Therefore, management of veterans with limb loss requires a comprehensive, coordinated, transdisciplinary program of services throughout the continuum of care. This includes offering the latest practices in medical interventions, artificial limbs, assistive technologies, and rehabilitation strategies to restore function and thereby optimize quality of life.
Amputation System of Care
The ASoC is an integrated system within the Veterans Health Administration (VHA) that provides specialized expertise in amputation rehabilitation incorporating the latest practices in medical management, rehabilitation therapies, artificial limbs, and assistive technologies. The system facilitates patient-centered, gender-sensitive, lifelong care and care coordination across the entire health continuum from acute inpatient hospitalization through a spectrum of inpatient, residential, and outpatient rehabilitation care settings. Through the provision of quality rehabilitation and prosthetic limb care, the ASoC strives to minimize disability and enable the highest level of social, vocational, and recreational success for veterans with an amputation.1-3
The policy and procedures for the ASoC have been detailed in prior VA Handbooks and in the ASoC Directive.1 This article highlights the background, population served, and organizational structure of the ASoC by detailing the outcomes and accomplishments of this systems-based approach to longitudinal amputation care between 2009 and 2019. Four core areas of activities and accomplishments are highlighted: (1) learning organization creation; (2) trust in VA care; (3) system modernization; and (4) customer service. This analysis and description of the VA amputation care program serves as a model of amputation care that can be used in the civilian sector. There also is potential for the ASoC to serve as a care model example for other populations within the VA.
Organizational Structure
The ASoC is an integrated, national health care delivery system in which each VA medical center (VAMC) has a specific designation that reflects the level of expertise and accessibility across the system based on an individual veteran’s needs and the specific capabilities of each VAMC.1-3 The organizational structure for the ASoC is similar to the Polytrauma System of Care in that facilities are divided into 4 tiers.1,4
For the ASoC, the 4 tiers are Regional Amputation Centers (RAC) at 7 VAMCs, Polytrauma Amputation Network Sites (PANS) at 18 VAMCs, Amputation Clinic Teams (ACT) at 106 VAMCs, and Amputation Points of Contact (APoC) at 22 VAMCs. The RAC locations provide the highest level of specialized expertise in clinical care and prosthetic limb technology and have rehabilitation capabilities to manage the most complicated cases. Like the RAC facilities, PANS provide a full range of clinical and ancillary services to veterans within their catchment area and serve as referral locations for veterans with needs that are more complex. ACT sites have a core amputation specialty team that provides regular follow-up and address ongoing care needs. ACT sites may or may not have full ancillary services, such as surgical subspecialties or an in-house prosthetics laboratory. APoC facilities have at least 1 person on staff who serves as the point of contact for consultation, assessment, and referral of a veteran with an amputation to a facility capable of providing the level of services required.1
The VA also places a high priority on both primary and secondary amputation prevention. The Preventing Amputations in Veterans Everywhere (PAVE) program and the ASoC coordinate efforts in order to address the prevention of an initial amputation, the rehabilitation of veterans who have had an amputation, and the prevention of a second amputation in those with an amputation.1,5
Population Served
The ASoC serves veterans with limb loss regardless of the etiology. This includes care of individuals with complex limb trauma and those with other injuries or disease processes resulting in a high likelihood of requiring a limb amputation. In 2019, the VA provided care to 96,519 veterans with amputation, and about half (46,214) had at least 1 major limb amputation, which is defined as an amputation at or proximal to the wrist or ankle.6 The majority of veterans with amputation treated within the VA have limb loss resulting from disease processes, such as diabetes mellitus (DM) and peripheral vascular disease (PVD). Amputations caused by these diseases generally occur in the older veteran population and are associated with comorbidities, such as cardiovascular disease, hypertension, and end-stage renal disease. Veterans with amputation due to trauma, including conflict-related injuries, are commonly younger at the time of their amputation. Although the number of conflict-related amputations is small compared with the number of amputations associated with disease processes, both groups require high-quality, comprehensive, lifelong care.
Between 2009 and 2019, the number of veterans with limb loss receiving care in the VA increased 34%.6 With advances in vascular surgery and limb-sparing procedures, minor amputations are more common than major limb amputations and more below-knee rather than above-knee amputations have been noted over the same time. However, the high prevalence of DM in the overall veteran population places about 1.8 million veterans at risk for amputation, and it is anticipated that the volume of limb loss in the veteran population will continue to grow and possibly accelerate.5
Performance Metrics
During this same period, the amputation specialty clinic encounter to unique ratio (a measure of how frequently patients return to the clinic each year) rose from 1.8 in 2009 to 2.3 in 2019 for both the total amputation population and for those with major limb amputation. When looking more specifically at the RAC facilities, the encounter to unique ratio increased from 1.5 to 3.0 over the same time, reflecting the added benefit of having dedicated resources for the amputation specialty program.6
Comparing the percentage of veterans with amputation who are seen in the VA for any service with those who also are seen in the amputation specialty clinic in the same year is a performance metric that reflects the penetration of amputation specialty services across the system. Between 2009 and 2019, this increased from 2.9 to 12.7% for the overall amputation population and from 4.8 to 26% for those with major limb amputation (Figure 2). This metric improved to a greater extent in RAC facilities; 44% of veterans with major limb amputation seen at a RAC were also seen in the amputation specialty clinic in 2019.6
System Hallmarks
One of the primary hallmarks of the ASoC is the interdisciplinary team approach addressing all aspects of management across the continuum of care (Table). The core team consists of a physician, therapist, and prosthetist, and may include a variety of other disciplines based on a veteran’s individual needs. This model promotes veteran-centric care. Comprehensive management of veterans with limb loss includes addressing medical considerations such as residual limb skin health to the prescription of artificial limbs and the provision of therapy services for prosthetic limb gait training.1,2
Lifelong care for veterans living with limb loss is another hallmark of the ASoC. The provision of care coordination across the continuum of care from acute hospitalization following an amputation to long-term follow-up in the outpatient setting for veteran’s lifespan is essential. Care coordination is provided across the system of care, which assures that a veteran with limb loss can obtain the required services through consultation or referral to a RAC or PANS as needed. Care coordination for the ASoC is facilitated by amputation rehabilitation coordinators at each of the RAC and PANS designated VAMCs.
Integration of services and resource collaboration are additional key aspects of the ASoC (Figure 3). In order to be successful, care of the veteran facing potential amputation or living with the challenges postamputation must be well-integrated into the broader care of the individual. Many veterans who undergo amputation have significant medical comorbidities, including a high prevalence of DM and peripheral vascular disease. Management of these conditions in collaboration with primary care and other medical specialties promotes the achievement of rehabilitation goals. Integration of surgical services and amputation prevention strategies is critical. Another essential element of the system is maintaining amputation specialty care team contact with all veterans with limb loss on at least an annual basis. A clinical practice guideline published in 2017 on lower Limb amputation rehabilitation emphasizes this need for an annual contact and includes a management and referral algorithm to assist primary care providers in the management of veterans with amputation (Figure 4).7
Collaboration with external partners has been an important element in the system of care development. The VA has partnered extensively with the US Department of Defense (DoD) to transition service members with amputation from the military health care system to the VA. The VA and DoD also have collaborated through the development and provision of joint provider trainings, clinical practice guidelines, incentive funding programs, and patient education materials. Congress authorized the Extremity Trauma and Amputation Center of Excellence (EACE) in 2009 with the mission to serve as the joint DoD and VA lead element focused on the mitigation, treatment, and rehabilitation of traumatic extremity injuries and amputations. The EACE has several lines of effort, including clinical affairs, research, and global outreach focused on building partnerships and fostering collaboration to optimize quality of life for those with extremity trauma and amputation. The Amputee Coalition, the largest nonprofit consumer-based amputee advocacy organization in the US, has been an important strategic partner for the dissemination of guideline recommendations and patient education as well as the development and provision of peer support services.
Methods
The ASoC created a learning organization to develop and maintain a knowledgeable and highly skilled clinical workforce through the identification of best practices related to amputation rehabilitation and the use of innovative education delivery models. During the past 10 years, the ASoC conducted 9 national, live health care provider training events in conjunction with the DoD. In conjunction with the EACE, the ASoC holds 6 national Grand Rounds sessions each year. Dissemination of information and trainings across both the VA and DoD has been facilitated through a national listserv referred to as the Federal Amputation Interest Group (FAIG), which has > 800 members. Since 2009, the VA, in collaboration with the DoD, has produced 3 clinical practice guidelines (CPGs) related to amputation care. The Lower Limb Amputation CPG was published in 2007 and updated in 2017, and a CPG and associated clinician resources focused on upper extremity amputation were published in 2014.7,8 In addition to these formal, comprehensive, and evidence-driven guidelines, the ASoC has developed other clinical support documents covering a range of topics from prosthesis prescription candidacy determination to osseointegration. In conjunction with the EACE, The ASoC also has published guidance for clinical implementation of new technologies such as the Mobius Bionics LUKE arm and Dynamic Response Ankle-Foot Orthoses.
The ASoC strives to improve the psychosocial welfare of veterans with amputation and enhance trust in VA amputation care services through sharing results on the quality and timeliness of care. The Commission on Accreditation for Rehabilitation Facilities (CARF) provides an international, independent, peer-reviewed system of accreditation that is widely recognized by federal agencies, state governments, major insurers, and professional organizations.1,2 CARF offers amputation specialty accreditation for inpatient and outpatient programs that signifies the attainment of a distinguished level of expertise and the provision of a comprehensive spectrum of services related to amputation care and rehabilitation. During its development, the ASoC established the expectation that each of the RAC and PANS designated VAMCs would attain and maintain CARF amputation specialty accreditation. The ASoC has achieved 100% success on this metric.
In addition, the ASoC has completed many other initiatives focused on enhancing trust in VA amputation care services. These include assuring compliance with implementation of the Mission Act as it relates to the provision of amputation care and prosthetic limb delivery so that any services provided in the community are well integrated and at the direction of the amputation specialty team. The ASoC has maintained a strong relationship with the Amputee Coalition to provide veterans with high-quality patient education materials as well as integrated peer support services.
ASoC virtual and face-to-face training events incorporate suicide prevention training for providers. Special focus has been placed on care provision for Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn veterans with conflict-related multiple limb amputations. Although relatively small, this cohort is recognized as a unique and important population due to their unique care needs and increased risk for secondary complications. In 2019, 83% of these individuals were contacted to assure their amputation care needs were being adequately addressed.
Discussion
Over the past 10 years, the ASoC has built a modern, high-performance network of care to best serve veterans with amputation. Maturation of the system has included the addition of 3 new PANS locations to improve access to services as well as to better support geographic regions near large DoD military treatment facilities. The number of ACT designated VAMCs also has grown from 101 to 106 locations. The regional organization of sites has been modified to enhance the availability of referral and consultative services across the system. In addition, the ASoC has supported the development of an upper extremity amputation specialty program for consultation or referral to a highly specialized team of providers well versed in the significant technology advances that have taken place with upper extremity prostheses.9
One of the key components to high-performance network development is attaining a clear picture of the clinical demands and service delivery needs of the population served. The Amputee Data Repository was developed with the support of the VHA Support Service Center (VSSC) in order to better understand and track the population of veterans with amputation.6 The development and implementation of the Amputee Data Repository took place over several years, and the product was officially released into publication in 2015. The overall goals of this resource are to provide a data system for the ASoC to identify clinical care volumes and patterns of treatment; better understand the demographics of the veteran amputee population; assess the effectiveness of new treatment strategies; and utilize data analysis outcomes to influence clinical practice. The acquisition and analysis of this information will provide justification for the modification of clinical practice and will enhance the quality of care for all veterans with amputation.
Although the ASoC focuses primarily on the provision of clinical services, the system has been leveraged to support research activities and the advancement of artificial limb technologies. For example, ASoC providers and investigators supported the clinical research required to test and optimize the development of the DEKA arm. These research efforts resulted in the US Food and Drug Administration approval and commercialization of this device. Once the device became commercially available as the LUKE arm, the ASoC developed a clinical implementation strategy that assured availability and appropriate prescription and training with the new technology. The VA also has supported research and program development in osseointegration with further investigations and clinical implementation being planned.
Telehealth
The goal of the ASoC is to provide timely access and greater choice to specialty amputation rehabilitation services for veterans as determined by their clinical needs. One key strategy used to achieve this goal has been the expansion of virtual communication tools to enhance access to clinical expertise. Telehealth (Virtual Care) amputation services afford the opportunity to provide specialized clinical expertise to veterans who otherwise may not have access to this level of service or consultation.1,2 For others, virtual care services reduce the need for travel. The ASoC has leveraged these services effectively to enhance specialty amputation care for veterans in rural areas. Over time, the scope of virtual care services has expanded to provide virtual peer support services as well as care in the veteran’s home.
Another unique example is the use of virtual care to see veterans when they are being provided services by a community prosthetist. This service improves the timeliness of care and reduces the travel burden for the veteran. Between 2009 and 2019, total virtual care encounters to provide amputation-related services grew from 44 encounters to 3,905 encounters (Figure 5). In 2019, 13.8% of veterans seen in a VA outpatient amputation specialty clinic had at least 1 virtual encounter in the same year.6
In addition to the expansion of virtual care and building capacity through increasing the number of amputation specialty clinics and providers, the ASoC has used a host of other strategies to improve care access. The development of provider expertise in amputation care has been achieved through the methods of extensive provider training. Implementation of Patient Self-Referral Direct Scheduling allows veterans to access the outpatient amputation specialty clinic without a referral and without having to be seen by their primary care provider. This initiative provides easier and more timely access to amputation specialty services while reducing burden on primary care services. The amputation outpatient specialty clinic was one of a few specialty programs to be an early adopter of national online scheduling. The implementation of this service is still ongoing, but this program gives veterans greater control over scheduling, canceling, and rescheduling appointments.
Conclusions
During the 10 years following its implementation, the VA ASoC has successfully enhanced the quality and consistency of care and rehabilitation services provided to veterans with limb loss through the provision of highly specialized services in the areas of medical care, rehabilitation services, and prosthetic technology. This mission has been accomplished through prioritization and implementation of key strategic initiatives in learning organization creation, trust in VA care, development of a modern, high-performance network, and customer service. Collaborative partnerships both internally within the VA and externally with key stakeholders has facilitated this development, and these will need to be enhanced for future success. Evolving trends in amputation surgery, limb transplantation, artificial limb control and suspension strategies as well as advances in assistive technology also will need to be integrated into best practices and program development.
The US Department of Veterans Affairs (VA) established a formal Amputation System of Care (ASoC) in 2008 with the goal of enhancing the quality and consistency of amputation rehabilitation care for veterans with limb loss.1,2 Throughout its history, the VA has placed a high priority on the care that is provided to veterans with limb amputation.1,3 Amputations have medical, physical, social, and psychological ramifications for the veteran and his or her family. Therefore, management of veterans with limb loss requires a comprehensive, coordinated, transdisciplinary program of services throughout the continuum of care. This includes offering the latest practices in medical interventions, artificial limbs, assistive technologies, and rehabilitation strategies to restore function and thereby optimize quality of life.
Amputation System of Care
The ASoC is an integrated system within the Veterans Health Administration (VHA) that provides specialized expertise in amputation rehabilitation incorporating the latest practices in medical management, rehabilitation therapies, artificial limbs, and assistive technologies. The system facilitates patient-centered, gender-sensitive, lifelong care and care coordination across the entire health continuum from acute inpatient hospitalization through a spectrum of inpatient, residential, and outpatient rehabilitation care settings. Through the provision of quality rehabilitation and prosthetic limb care, the ASoC strives to minimize disability and enable the highest level of social, vocational, and recreational success for veterans with an amputation.1-3
The policy and procedures for the ASoC have been detailed in prior VA Handbooks and in the ASoC Directive.1 This article highlights the background, population served, and organizational structure of the ASoC by detailing the outcomes and accomplishments of this systems-based approach to longitudinal amputation care between 2009 and 2019. Four core areas of activities and accomplishments are highlighted: (1) learning organization creation; (2) trust in VA care; (3) system modernization; and (4) customer service. This analysis and description of the VA amputation care program serves as a model of amputation care that can be used in the civilian sector. There also is potential for the ASoC to serve as a care model example for other populations within the VA.
Organizational Structure
The ASoC is an integrated, national health care delivery system in which each VA medical center (VAMC) has a specific designation that reflects the level of expertise and accessibility across the system based on an individual veteran’s needs and the specific capabilities of each VAMC.1-3 The organizational structure for the ASoC is similar to the Polytrauma System of Care in that facilities are divided into 4 tiers.1,4
For the ASoC, the 4 tiers are Regional Amputation Centers (RAC) at 7 VAMCs, Polytrauma Amputation Network Sites (PANS) at 18 VAMCs, Amputation Clinic Teams (ACT) at 106 VAMCs, and Amputation Points of Contact (APoC) at 22 VAMCs. The RAC locations provide the highest level of specialized expertise in clinical care and prosthetic limb technology and have rehabilitation capabilities to manage the most complicated cases. Like the RAC facilities, PANS provide a full range of clinical and ancillary services to veterans within their catchment area and serve as referral locations for veterans with needs that are more complex. ACT sites have a core amputation specialty team that provides regular follow-up and address ongoing care needs. ACT sites may or may not have full ancillary services, such as surgical subspecialties or an in-house prosthetics laboratory. APoC facilities have at least 1 person on staff who serves as the point of contact for consultation, assessment, and referral of a veteran with an amputation to a facility capable of providing the level of services required.1
The VA also places a high priority on both primary and secondary amputation prevention. The Preventing Amputations in Veterans Everywhere (PAVE) program and the ASoC coordinate efforts in order to address the prevention of an initial amputation, the rehabilitation of veterans who have had an amputation, and the prevention of a second amputation in those with an amputation.1,5
Population Served
The ASoC serves veterans with limb loss regardless of the etiology. This includes care of individuals with complex limb trauma and those with other injuries or disease processes resulting in a high likelihood of requiring a limb amputation. In 2019, the VA provided care to 96,519 veterans with amputation, and about half (46,214) had at least 1 major limb amputation, which is defined as an amputation at or proximal to the wrist or ankle.6 The majority of veterans with amputation treated within the VA have limb loss resulting from disease processes, such as diabetes mellitus (DM) and peripheral vascular disease (PVD). Amputations caused by these diseases generally occur in the older veteran population and are associated with comorbidities, such as cardiovascular disease, hypertension, and end-stage renal disease. Veterans with amputation due to trauma, including conflict-related injuries, are commonly younger at the time of their amputation. Although the number of conflict-related amputations is small compared with the number of amputations associated with disease processes, both groups require high-quality, comprehensive, lifelong care.
Between 2009 and 2019, the number of veterans with limb loss receiving care in the VA increased 34%.6 With advances in vascular surgery and limb-sparing procedures, minor amputations are more common than major limb amputations and more below-knee rather than above-knee amputations have been noted over the same time. However, the high prevalence of DM in the overall veteran population places about 1.8 million veterans at risk for amputation, and it is anticipated that the volume of limb loss in the veteran population will continue to grow and possibly accelerate.5
Performance Metrics
During this same period, the amputation specialty clinic encounter to unique ratio (a measure of how frequently patients return to the clinic each year) rose from 1.8 in 2009 to 2.3 in 2019 for both the total amputation population and for those with major limb amputation. When looking more specifically at the RAC facilities, the encounter to unique ratio increased from 1.5 to 3.0 over the same time, reflecting the added benefit of having dedicated resources for the amputation specialty program.6
Comparing the percentage of veterans with amputation who are seen in the VA for any service with those who also are seen in the amputation specialty clinic in the same year is a performance metric that reflects the penetration of amputation specialty services across the system. Between 2009 and 2019, this increased from 2.9 to 12.7% for the overall amputation population and from 4.8 to 26% for those with major limb amputation (Figure 2). This metric improved to a greater extent in RAC facilities; 44% of veterans with major limb amputation seen at a RAC were also seen in the amputation specialty clinic in 2019.6
System Hallmarks
One of the primary hallmarks of the ASoC is the interdisciplinary team approach addressing all aspects of management across the continuum of care (Table). The core team consists of a physician, therapist, and prosthetist, and may include a variety of other disciplines based on a veteran’s individual needs. This model promotes veteran-centric care. Comprehensive management of veterans with limb loss includes addressing medical considerations such as residual limb skin health to the prescription of artificial limbs and the provision of therapy services for prosthetic limb gait training.1,2
Lifelong care for veterans living with limb loss is another hallmark of the ASoC. The provision of care coordination across the continuum of care from acute hospitalization following an amputation to long-term follow-up in the outpatient setting for veteran’s lifespan is essential. Care coordination is provided across the system of care, which assures that a veteran with limb loss can obtain the required services through consultation or referral to a RAC or PANS as needed. Care coordination for the ASoC is facilitated by amputation rehabilitation coordinators at each of the RAC and PANS designated VAMCs.
Integration of services and resource collaboration are additional key aspects of the ASoC (Figure 3). In order to be successful, care of the veteran facing potential amputation or living with the challenges postamputation must be well-integrated into the broader care of the individual. Many veterans who undergo amputation have significant medical comorbidities, including a high prevalence of DM and peripheral vascular disease. Management of these conditions in collaboration with primary care and other medical specialties promotes the achievement of rehabilitation goals. Integration of surgical services and amputation prevention strategies is critical. Another essential element of the system is maintaining amputation specialty care team contact with all veterans with limb loss on at least an annual basis. A clinical practice guideline published in 2017 on lower Limb amputation rehabilitation emphasizes this need for an annual contact and includes a management and referral algorithm to assist primary care providers in the management of veterans with amputation (Figure 4).7
Collaboration with external partners has been an important element in the system of care development. The VA has partnered extensively with the US Department of Defense (DoD) to transition service members with amputation from the military health care system to the VA. The VA and DoD also have collaborated through the development and provision of joint provider trainings, clinical practice guidelines, incentive funding programs, and patient education materials. Congress authorized the Extremity Trauma and Amputation Center of Excellence (EACE) in 2009 with the mission to serve as the joint DoD and VA lead element focused on the mitigation, treatment, and rehabilitation of traumatic extremity injuries and amputations. The EACE has several lines of effort, including clinical affairs, research, and global outreach focused on building partnerships and fostering collaboration to optimize quality of life for those with extremity trauma and amputation. The Amputee Coalition, the largest nonprofit consumer-based amputee advocacy organization in the US, has been an important strategic partner for the dissemination of guideline recommendations and patient education as well as the development and provision of peer support services.
Methods
The ASoC created a learning organization to develop and maintain a knowledgeable and highly skilled clinical workforce through the identification of best practices related to amputation rehabilitation and the use of innovative education delivery models. During the past 10 years, the ASoC conducted 9 national, live health care provider training events in conjunction with the DoD. In conjunction with the EACE, the ASoC holds 6 national Grand Rounds sessions each year. Dissemination of information and trainings across both the VA and DoD has been facilitated through a national listserv referred to as the Federal Amputation Interest Group (FAIG), which has > 800 members. Since 2009, the VA, in collaboration with the DoD, has produced 3 clinical practice guidelines (CPGs) related to amputation care. The Lower Limb Amputation CPG was published in 2007 and updated in 2017, and a CPG and associated clinician resources focused on upper extremity amputation were published in 2014.7,8 In addition to these formal, comprehensive, and evidence-driven guidelines, the ASoC has developed other clinical support documents covering a range of topics from prosthesis prescription candidacy determination to osseointegration. In conjunction with the EACE, The ASoC also has published guidance for clinical implementation of new technologies such as the Mobius Bionics LUKE arm and Dynamic Response Ankle-Foot Orthoses.
The ASoC strives to improve the psychosocial welfare of veterans with amputation and enhance trust in VA amputation care services through sharing results on the quality and timeliness of care. The Commission on Accreditation for Rehabilitation Facilities (CARF) provides an international, independent, peer-reviewed system of accreditation that is widely recognized by federal agencies, state governments, major insurers, and professional organizations.1,2 CARF offers amputation specialty accreditation for inpatient and outpatient programs that signifies the attainment of a distinguished level of expertise and the provision of a comprehensive spectrum of services related to amputation care and rehabilitation. During its development, the ASoC established the expectation that each of the RAC and PANS designated VAMCs would attain and maintain CARF amputation specialty accreditation. The ASoC has achieved 100% success on this metric.
In addition, the ASoC has completed many other initiatives focused on enhancing trust in VA amputation care services. These include assuring compliance with implementation of the Mission Act as it relates to the provision of amputation care and prosthetic limb delivery so that any services provided in the community are well integrated and at the direction of the amputation specialty team. The ASoC has maintained a strong relationship with the Amputee Coalition to provide veterans with high-quality patient education materials as well as integrated peer support services.
ASoC virtual and face-to-face training events incorporate suicide prevention training for providers. Special focus has been placed on care provision for Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn veterans with conflict-related multiple limb amputations. Although relatively small, this cohort is recognized as a unique and important population due to their unique care needs and increased risk for secondary complications. In 2019, 83% of these individuals were contacted to assure their amputation care needs were being adequately addressed.
Discussion
Over the past 10 years, the ASoC has built a modern, high-performance network of care to best serve veterans with amputation. Maturation of the system has included the addition of 3 new PANS locations to improve access to services as well as to better support geographic regions near large DoD military treatment facilities. The number of ACT designated VAMCs also has grown from 101 to 106 locations. The regional organization of sites has been modified to enhance the availability of referral and consultative services across the system. In addition, the ASoC has supported the development of an upper extremity amputation specialty program for consultation or referral to a highly specialized team of providers well versed in the significant technology advances that have taken place with upper extremity prostheses.9
One of the key components to high-performance network development is attaining a clear picture of the clinical demands and service delivery needs of the population served. The Amputee Data Repository was developed with the support of the VHA Support Service Center (VSSC) in order to better understand and track the population of veterans with amputation.6 The development and implementation of the Amputee Data Repository took place over several years, and the product was officially released into publication in 2015. The overall goals of this resource are to provide a data system for the ASoC to identify clinical care volumes and patterns of treatment; better understand the demographics of the veteran amputee population; assess the effectiveness of new treatment strategies; and utilize data analysis outcomes to influence clinical practice. The acquisition and analysis of this information will provide justification for the modification of clinical practice and will enhance the quality of care for all veterans with amputation.
Although the ASoC focuses primarily on the provision of clinical services, the system has been leveraged to support research activities and the advancement of artificial limb technologies. For example, ASoC providers and investigators supported the clinical research required to test and optimize the development of the DEKA arm. These research efforts resulted in the US Food and Drug Administration approval and commercialization of this device. Once the device became commercially available as the LUKE arm, the ASoC developed a clinical implementation strategy that assured availability and appropriate prescription and training with the new technology. The VA also has supported research and program development in osseointegration with further investigations and clinical implementation being planned.
Telehealth
The goal of the ASoC is to provide timely access and greater choice to specialty amputation rehabilitation services for veterans as determined by their clinical needs. One key strategy used to achieve this goal has been the expansion of virtual communication tools to enhance access to clinical expertise. Telehealth (Virtual Care) amputation services afford the opportunity to provide specialized clinical expertise to veterans who otherwise may not have access to this level of service or consultation.1,2 For others, virtual care services reduce the need for travel. The ASoC has leveraged these services effectively to enhance specialty amputation care for veterans in rural areas. Over time, the scope of virtual care services has expanded to provide virtual peer support services as well as care in the veteran’s home.
Another unique example is the use of virtual care to see veterans when they are being provided services by a community prosthetist. This service improves the timeliness of care and reduces the travel burden for the veteran. Between 2009 and 2019, total virtual care encounters to provide amputation-related services grew from 44 encounters to 3,905 encounters (Figure 5). In 2019, 13.8% of veterans seen in a VA outpatient amputation specialty clinic had at least 1 virtual encounter in the same year.6
In addition to the expansion of virtual care and building capacity through increasing the number of amputation specialty clinics and providers, the ASoC has used a host of other strategies to improve care access. The development of provider expertise in amputation care has been achieved through the methods of extensive provider training. Implementation of Patient Self-Referral Direct Scheduling allows veterans to access the outpatient amputation specialty clinic without a referral and without having to be seen by their primary care provider. This initiative provides easier and more timely access to amputation specialty services while reducing burden on primary care services. The amputation outpatient specialty clinic was one of a few specialty programs to be an early adopter of national online scheduling. The implementation of this service is still ongoing, but this program gives veterans greater control over scheduling, canceling, and rescheduling appointments.
Conclusions
During the 10 years following its implementation, the VA ASoC has successfully enhanced the quality and consistency of care and rehabilitation services provided to veterans with limb loss through the provision of highly specialized services in the areas of medical care, rehabilitation services, and prosthetic technology. This mission has been accomplished through prioritization and implementation of key strategic initiatives in learning organization creation, trust in VA care, development of a modern, high-performance network, and customer service. Collaborative partnerships both internally within the VA and externally with key stakeholders has facilitated this development, and these will need to be enhanced for future success. Evolving trends in amputation surgery, limb transplantation, artificial limb control and suspension strategies as well as advances in assistive technology also will need to be integrated into best practices and program development.
1. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1172.03(1): Amputation system of care. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7482. Published August 3, 2018. Accessed July 31, 2020.
2. Webster JB, Poorman CE, Cifu DX. Guest editorial: Department of Veterans Affairs Amputations System of care: 5 years of accomplishments and outcomes. J Rehabil Res Dev. 2014;51(4):vii-xvi. doi:10.1682/JRRD.2014.01.0024
3. Reiber GE, Smith DG. VA paradigm shift in care of veterans with limb loss. J Rehabil Res Dev. 2010;47(4):vii-x. doi:10.1682/jrrd.2010.03.0030
4. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1172.01: Polytrauma system of care. https://www.va.gov/OPTOMETRY/docs/VHA_Directive_1172-01_Polytrauma_System_of_Care_1172_01_D_2019-01-24.pdf. Published January 24, 2019. Accessed July 31, 2020.
5. VHA Directive 1410, Prevention of amputation in veterans everywhere (PAVE) program, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5364. Published March 31, 2017. Accessed July 31, 2020.
6. VHA Amputee Data Repository. VHA Support Service Center. http://vssc.med.va.gov. [Nonpublic source, not verified.]
7. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: rehabilitation of lower limb amputation. Version 2.0 -2017. https://www.healthquality.va.gov/guidelines/Rehab/amp/VADoDLLACPG092817.pdf. Accessed July 16, 2020.
8. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: The Management of upper extremity amputation rehabilitation.Version 1-2014. https://www.healthquality.va.gov/guidelines/Rehab/UEAR/VADoDCPGManagementofUEAR121614Corrected508.pdf. Accessed July 16, 2020.
9. Resnik L, Meucci MR, Lieberman-Klinger S, et al. Advanced upper limb prosthetic devices: implications for upper limb prosthetic rehabilitation. Arch Phys Med Rehabil. 2012;93(4):710-717. doi:10.1016/j.apmr.2011.11.010
10. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: rehabilitation of lower limb amputation. Version 2.0 -2017. Pocket card. https://www.healthquality.va.gov/guidelines/Rehab/amp/VADoDLLACPGPocketCard092817.pdf. Accessed July 31, 2020.
1. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1172.03(1): Amputation system of care. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7482. Published August 3, 2018. Accessed July 31, 2020.
2. Webster JB, Poorman CE, Cifu DX. Guest editorial: Department of Veterans Affairs Amputations System of care: 5 years of accomplishments and outcomes. J Rehabil Res Dev. 2014;51(4):vii-xvi. doi:10.1682/JRRD.2014.01.0024
3. Reiber GE, Smith DG. VA paradigm shift in care of veterans with limb loss. J Rehabil Res Dev. 2010;47(4):vii-x. doi:10.1682/jrrd.2010.03.0030
4. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1172.01: Polytrauma system of care. https://www.va.gov/OPTOMETRY/docs/VHA_Directive_1172-01_Polytrauma_System_of_Care_1172_01_D_2019-01-24.pdf. Published January 24, 2019. Accessed July 31, 2020.
5. VHA Directive 1410, Prevention of amputation in veterans everywhere (PAVE) program, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5364. Published March 31, 2017. Accessed July 31, 2020.
6. VHA Amputee Data Repository. VHA Support Service Center. http://vssc.med.va.gov. [Nonpublic source, not verified.]
7. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: rehabilitation of lower limb amputation. Version 2.0 -2017. https://www.healthquality.va.gov/guidelines/Rehab/amp/VADoDLLACPG092817.pdf. Accessed July 16, 2020.
8. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: The Management of upper extremity amputation rehabilitation.Version 1-2014. https://www.healthquality.va.gov/guidelines/Rehab/UEAR/VADoDCPGManagementofUEAR121614Corrected508.pdf. Accessed July 16, 2020.
9. Resnik L, Meucci MR, Lieberman-Klinger S, et al. Advanced upper limb prosthetic devices: implications for upper limb prosthetic rehabilitation. Arch Phys Med Rehabil. 2012;93(4):710-717. doi:10.1016/j.apmr.2011.11.010
10. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guidelines: rehabilitation of lower limb amputation. Version 2.0 -2017. Pocket card. https://www.healthquality.va.gov/guidelines/Rehab/amp/VADoDLLACPGPocketCard092817.pdf. Accessed July 31, 2020.
Pandemic hampers reopening of joint replacement gold mine
Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.
“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.
Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible – an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.
The cost of joint replacement surgery varies widely – though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.
The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.
Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March – and again in July in some areas plagued by renewed COVID outbreaks.
“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.
It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.
But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.
That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.
If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.
The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.
Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.
At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.
At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May – cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.
In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.
The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.
In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.
The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.
It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers – especially on younger, healthier patients who don’t require hospitalization.
The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.
“[G]enerally the savings should be very good – but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money – $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.
Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.
“That was key to me – avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”
Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.
However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.
“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”
McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’ ”
This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation.
Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.
“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.
Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible – an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.
The cost of joint replacement surgery varies widely – though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.
The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.
Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March – and again in July in some areas plagued by renewed COVID outbreaks.
“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.
It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.
But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.
That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.
If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.
The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.
Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.
At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.
At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May – cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.
In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.
The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.
In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.
The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.
It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers – especially on younger, healthier patients who don’t require hospitalization.
The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.
“[G]enerally the savings should be very good – but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money – $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.
Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.
“That was key to me – avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”
Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.
However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.
“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”
McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’ ”
This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation.
Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.
“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.
Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible – an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.
The cost of joint replacement surgery varies widely – though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.
The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.
Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March – and again in July in some areas plagued by renewed COVID outbreaks.
“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.
It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.
But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.
That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.
If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.
The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.
Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.
At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.
At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May – cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.
In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.
The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.
In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.
The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.
It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers – especially on younger, healthier patients who don’t require hospitalization.
The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.
“[G]enerally the savings should be very good – but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money – $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.
Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.
“That was key to me – avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”
Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.
However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.
“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”
McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’ ”
This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation.
Delaying denosumab dose boosts risk for vertebral fractures
a new study confirms. Physicians say they are especially concerned about the risk facing patients who are delaying the treatment during the coronavirus pandemic.
The recommended doses of denosumab are at 6-month intervals. Patients who delayed a dose by more than 16 weeks were nearly four times more likely to suffer vertebral fractures, compared with those who received on-time injections, according to the study, which was published in Annals of Internal Medicine.
“Because patients who used denosumab were at high risk for vertebral fracture, strategies to improve timely administration of denosumab in routine clinical settings are needed,” wrote the study authors, led by Houchen Lyu, MD, PhD, of National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation at General Hospital of Chinese PLA in Beijing.
Denosumab, a human monoclonal antibody, is used to reduce bone loss in osteoporosis. The manufacturer of Prolia, a brand of the drug, recommends it be given every 6 months, but the study reports that it’s common for injections to be delayed.
Researchers have linked cessation of denosumab to higher risk of fractures, and Dr. Lyu led a study published earlier this year that linked less-frequent doses to less bone mineral density improvement. “However,” the authors of the new study wrote, “whether delaying subsequent injections beyond the recommended 6-month interval is associated with fractures is unknown.”
For their new study, researchers retrospectively analyzed data from 2,594 patients in the U.K. 45 years or older (mean age, 76; 94% female; 53% with a history of major osteoporotic fracture) who began taking denosumab between 2010 and 2019. They used a design that aimed to emulate a clinical trial, comparing three dosing intervals: “on time” (within 4 weeks of the recommended 6-month interval), “short delay” (within 4-16 weeks) and “long delay” (16 weeks to 6 months).
The study found that the risk of composite fracture over 6 months out of 1,000 was 27.3 for on-time dosing, 32.2 for short-delay dosing, and 42.4 for long-delay dosing. The hazard ratio for long-delay versus on-time was 1.44 (95% confidence interval, 0.96-2.17; P = .093).
Vertebral fractures were less likely, but delays boosted the risk significantly: Over 6 months, it grew from 2.2 in 1,000 (on time) to 3.6 in 1,000 (short delay) and 10.1 in 1,000 (long delay). The HR for long delay versus on time was 3.91 (95% CI, 1.62-9.45; P = .005).
“This study had limited statistical power for composite fracture and several secondary end points ... except for vertebral fracture. Thus, evidence was insufficient to conclude that fracture risk was increased at other anatomical sites.”
In an accompanying editorial, two physicians from the University of Minnesota, Minneapolis, noted that the study is “timely and relevant” since the coronavirus pandemic may disrupt dosage schedules more than usual. While the study has limitations, the “findings are consistent with known denosumab pharmacokinetics and prior studies of fracture incidence after denosumab treatment discontinuation, wrote Kristine E. Ensrud, MD, MPH, who is also of Minneapolis VA Health Care System, and John T. Schousboe, MD, PhD, who is also of HealthPartners Institute.
The editorial authors noted that, in light of the pandemic, “some organizations recommend temporary transition to an oral bisphosphonate in patients receiving denosumab treatment for whom continued treatment is not feasible within 7 to 8 months of their most recent injection.”
In an interview, endocrinologist and osteoporosis specialist Ethel Siris, MD, of Columbia University, New York, said many of her patients aren’t coming in for denosumab injections during the pandemic. “It’s hard enough to get people to show up every 6 months to get their shot when things are going nicely,” she said. “We’re talking older women who may be on a lot of other medications. People forget, and it’s difficult for the office to constantly remind some of them to get their shots at an infusion center.”
The lack of symptoms is another challenge to getting patients to return for doses, she said. “In osteoporosis, the only time something hurts is if you break it.”
Since the pandemic began, many patients have been avoiding medical offices because of fear of getting the coronavirus.
The new research is helpful because it shows that patients are “more likely to fracture if they delay,” Dr. Siris noted. The endocrinologist added that she has successfully convinced some patients to give themselves subcutaneous injections in the abdomen at home.
Dr. Siris said she has been able to watch patients do these injections on video to check their technique. Her patients have been impressed by “how easy it is and delighted to have accomplished it,” she said.
The study was funded by the National Institutes of Health China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation. The study authors, commentary authors, and Dr. Siris report no relevant disclosures.
SOURCE: Lyu H et al. Ann Intern Med. 2020 Jul 28. doi: 10.7326/M20-0882.
a new study confirms. Physicians say they are especially concerned about the risk facing patients who are delaying the treatment during the coronavirus pandemic.
The recommended doses of denosumab are at 6-month intervals. Patients who delayed a dose by more than 16 weeks were nearly four times more likely to suffer vertebral fractures, compared with those who received on-time injections, according to the study, which was published in Annals of Internal Medicine.
“Because patients who used denosumab were at high risk for vertebral fracture, strategies to improve timely administration of denosumab in routine clinical settings are needed,” wrote the study authors, led by Houchen Lyu, MD, PhD, of National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation at General Hospital of Chinese PLA in Beijing.
Denosumab, a human monoclonal antibody, is used to reduce bone loss in osteoporosis. The manufacturer of Prolia, a brand of the drug, recommends it be given every 6 months, but the study reports that it’s common for injections to be delayed.
Researchers have linked cessation of denosumab to higher risk of fractures, and Dr. Lyu led a study published earlier this year that linked less-frequent doses to less bone mineral density improvement. “However,” the authors of the new study wrote, “whether delaying subsequent injections beyond the recommended 6-month interval is associated with fractures is unknown.”
For their new study, researchers retrospectively analyzed data from 2,594 patients in the U.K. 45 years or older (mean age, 76; 94% female; 53% with a history of major osteoporotic fracture) who began taking denosumab between 2010 and 2019. They used a design that aimed to emulate a clinical trial, comparing three dosing intervals: “on time” (within 4 weeks of the recommended 6-month interval), “short delay” (within 4-16 weeks) and “long delay” (16 weeks to 6 months).
The study found that the risk of composite fracture over 6 months out of 1,000 was 27.3 for on-time dosing, 32.2 for short-delay dosing, and 42.4 for long-delay dosing. The hazard ratio for long-delay versus on-time was 1.44 (95% confidence interval, 0.96-2.17; P = .093).
Vertebral fractures were less likely, but delays boosted the risk significantly: Over 6 months, it grew from 2.2 in 1,000 (on time) to 3.6 in 1,000 (short delay) and 10.1 in 1,000 (long delay). The HR for long delay versus on time was 3.91 (95% CI, 1.62-9.45; P = .005).
“This study had limited statistical power for composite fracture and several secondary end points ... except for vertebral fracture. Thus, evidence was insufficient to conclude that fracture risk was increased at other anatomical sites.”
In an accompanying editorial, two physicians from the University of Minnesota, Minneapolis, noted that the study is “timely and relevant” since the coronavirus pandemic may disrupt dosage schedules more than usual. While the study has limitations, the “findings are consistent with known denosumab pharmacokinetics and prior studies of fracture incidence after denosumab treatment discontinuation, wrote Kristine E. Ensrud, MD, MPH, who is also of Minneapolis VA Health Care System, and John T. Schousboe, MD, PhD, who is also of HealthPartners Institute.
The editorial authors noted that, in light of the pandemic, “some organizations recommend temporary transition to an oral bisphosphonate in patients receiving denosumab treatment for whom continued treatment is not feasible within 7 to 8 months of their most recent injection.”
In an interview, endocrinologist and osteoporosis specialist Ethel Siris, MD, of Columbia University, New York, said many of her patients aren’t coming in for denosumab injections during the pandemic. “It’s hard enough to get people to show up every 6 months to get their shot when things are going nicely,” she said. “We’re talking older women who may be on a lot of other medications. People forget, and it’s difficult for the office to constantly remind some of them to get their shots at an infusion center.”
The lack of symptoms is another challenge to getting patients to return for doses, she said. “In osteoporosis, the only time something hurts is if you break it.”
Since the pandemic began, many patients have been avoiding medical offices because of fear of getting the coronavirus.
The new research is helpful because it shows that patients are “more likely to fracture if they delay,” Dr. Siris noted. The endocrinologist added that she has successfully convinced some patients to give themselves subcutaneous injections in the abdomen at home.
Dr. Siris said she has been able to watch patients do these injections on video to check their technique. Her patients have been impressed by “how easy it is and delighted to have accomplished it,” she said.
The study was funded by the National Institutes of Health China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation. The study authors, commentary authors, and Dr. Siris report no relevant disclosures.
SOURCE: Lyu H et al. Ann Intern Med. 2020 Jul 28. doi: 10.7326/M20-0882.
a new study confirms. Physicians say they are especially concerned about the risk facing patients who are delaying the treatment during the coronavirus pandemic.
The recommended doses of denosumab are at 6-month intervals. Patients who delayed a dose by more than 16 weeks were nearly four times more likely to suffer vertebral fractures, compared with those who received on-time injections, according to the study, which was published in Annals of Internal Medicine.
“Because patients who used denosumab were at high risk for vertebral fracture, strategies to improve timely administration of denosumab in routine clinical settings are needed,” wrote the study authors, led by Houchen Lyu, MD, PhD, of National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation at General Hospital of Chinese PLA in Beijing.
Denosumab, a human monoclonal antibody, is used to reduce bone loss in osteoporosis. The manufacturer of Prolia, a brand of the drug, recommends it be given every 6 months, but the study reports that it’s common for injections to be delayed.
Researchers have linked cessation of denosumab to higher risk of fractures, and Dr. Lyu led a study published earlier this year that linked less-frequent doses to less bone mineral density improvement. “However,” the authors of the new study wrote, “whether delaying subsequent injections beyond the recommended 6-month interval is associated with fractures is unknown.”
For their new study, researchers retrospectively analyzed data from 2,594 patients in the U.K. 45 years or older (mean age, 76; 94% female; 53% with a history of major osteoporotic fracture) who began taking denosumab between 2010 and 2019. They used a design that aimed to emulate a clinical trial, comparing three dosing intervals: “on time” (within 4 weeks of the recommended 6-month interval), “short delay” (within 4-16 weeks) and “long delay” (16 weeks to 6 months).
The study found that the risk of composite fracture over 6 months out of 1,000 was 27.3 for on-time dosing, 32.2 for short-delay dosing, and 42.4 for long-delay dosing. The hazard ratio for long-delay versus on-time was 1.44 (95% confidence interval, 0.96-2.17; P = .093).
Vertebral fractures were less likely, but delays boosted the risk significantly: Over 6 months, it grew from 2.2 in 1,000 (on time) to 3.6 in 1,000 (short delay) and 10.1 in 1,000 (long delay). The HR for long delay versus on time was 3.91 (95% CI, 1.62-9.45; P = .005).
“This study had limited statistical power for composite fracture and several secondary end points ... except for vertebral fracture. Thus, evidence was insufficient to conclude that fracture risk was increased at other anatomical sites.”
In an accompanying editorial, two physicians from the University of Minnesota, Minneapolis, noted that the study is “timely and relevant” since the coronavirus pandemic may disrupt dosage schedules more than usual. While the study has limitations, the “findings are consistent with known denosumab pharmacokinetics and prior studies of fracture incidence after denosumab treatment discontinuation, wrote Kristine E. Ensrud, MD, MPH, who is also of Minneapolis VA Health Care System, and John T. Schousboe, MD, PhD, who is also of HealthPartners Institute.
The editorial authors noted that, in light of the pandemic, “some organizations recommend temporary transition to an oral bisphosphonate in patients receiving denosumab treatment for whom continued treatment is not feasible within 7 to 8 months of their most recent injection.”
In an interview, endocrinologist and osteoporosis specialist Ethel Siris, MD, of Columbia University, New York, said many of her patients aren’t coming in for denosumab injections during the pandemic. “It’s hard enough to get people to show up every 6 months to get their shot when things are going nicely,” she said. “We’re talking older women who may be on a lot of other medications. People forget, and it’s difficult for the office to constantly remind some of them to get their shots at an infusion center.”
The lack of symptoms is another challenge to getting patients to return for doses, she said. “In osteoporosis, the only time something hurts is if you break it.”
Since the pandemic began, many patients have been avoiding medical offices because of fear of getting the coronavirus.
The new research is helpful because it shows that patients are “more likely to fracture if they delay,” Dr. Siris noted. The endocrinologist added that she has successfully convinced some patients to give themselves subcutaneous injections in the abdomen at home.
Dr. Siris said she has been able to watch patients do these injections on video to check their technique. Her patients have been impressed by “how easy it is and delighted to have accomplished it,” she said.
The study was funded by the National Institutes of Health China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation. The study authors, commentary authors, and Dr. Siris report no relevant disclosures.
SOURCE: Lyu H et al. Ann Intern Med. 2020 Jul 28. doi: 10.7326/M20-0882.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Patients with osteoporosis who delay denosumab doses are at much higher risk for vertebral fractures.
Major finding: Over 6 months, the risk of vertebral fractures grew from 2.2 in 1,000 (on-time doses) to 10.1 in 1,000 (delay of more than 16 weeks) – a hazard ratio of 3.91 (confidence interval, 1.62 to 9.45; P = .005).
Study details: Retrospective analysis of 2,594 patients in the U.K. 45 years or older who began taking denosumab between 2010 and 2019.
Disclosures: The study was funded by the National Institutes of Health China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation. The study authors report no relevant disclosures.
Source: Lyu H et al. Ann Intern Med. 2020 Jul 28. doi: 10.7326/M20-0882.
COVID-19 symptoms can linger for months
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.