CASE 1 › Ms. T is an otherwise healthy 76 year old with a history of severe osteoarthritis (OA) in her right knee. She has participated in multiple rounds of physical therapy (PT) over the last 3 years. During the past year, she received 2 intra-articular corticosteroid injections, each of which provided only 3 to 4 weeks of pain relief, and one hyaluronic acid (HA) injection, which provided no benefit whatsoever.

Today, she describes her right knee pain as an 8 out of 10 and is frustrated by her lack of symptom relief. She was planning to have a total knee replacement and is a good surgical candidate, but recently found an article regarding platelet-rich plasma (PRP) injections for knee OA. She wants your opinion as to whether she should try this approach or proceed with surgery.

CASE 2 › Mr. H is a 44-year-old, right-handed dentist who has been suffering from right lateral epicondylitis for the past year. Although he has undergone PT and has been performing exercises at home since his symptoms began, he has not noticed a significant improvement. In the last 5 months, he has been out of work a total of 8 weeks due to the pain. He received one corticosteroid injection last month, which provided no improvement in symptoms. He is not interested in surgery, as he does not want to be out of work for a prolonged period of time.

He reports that one of his friends recently received a PRP injection for lateral epicondylitis and now feels great. He is aware that PRP injections are not covered by his health insurance and says he is willing to pay out of pocket if the treatment works. He wants to know if you recommend this course of action for his elbow pain.

How would you counsel each of these patients about the use of PRP injections for pain relief from their respective orthopedic conditions?

Musculoskeletal symptoms account for 10% to 28% of patients’ complaints to primary care physicians annually.¹ Treatment of both chronic tendinopathies and knee OA—2 of the most common causes of these complaints—typically follows a stepwise approach, beginning with anti-inflammatory and pain medications in addition to PT. Patients who fail to respond to these interventions are often treated with corticosteroid injections, and, in the case of knee OA, viscosupplementation (ie, HA injections) and braces. If these therapies fail, patients are often forced to choose between an invasive surgical procedure or continued pain and limited function.

Platelet-rich plasma is thought to tip the body’s response in favor of regeneration over destruction.

A number of physicians specializing in musculoskeletal medicine have turned to prolotherapy—specifically, dextrose prolotherapy (see “Prolotherapy: Can it help your patient?” J Fam Pract. 2015;64:763-768) and platelet-rich plasma (PRP) therapy—as an alternative treatment for chronic musculoskeletal conditions.

PRP has been used to enhance surgical healing and to treat muscle strains and chondropathies. It drew a great deal of attention in the media when it was used by such high-profile professional athletes as Tiger Woods and Kobe Bryant.

Although PRP therapy is not commonly reimbursed by health insurance companies because of a lack of large, definitive studies supporting its effectiveness, patients are paying anywhere from a few hundred to a few thousand dollars out of pocket for it. They’re doing so in the hope that it will treat their chronic musculoskeletal disorders or at least delay surgical procedures.

But what can these patients reasonably expect from this therapy?

The following review of the evidence for PRP in the treatment of knee OA and tendinopathies (including elbow epicondylitis, patellar tendinitis, and Achilles tendinitis) will help you counsel patients on its appropriate use.

What is PRP?

PRP is defined as a sample of autologous blood with concentrations of platelets above baseline values.² It is made through a one- or 2-stage centrifugation process in which the liquid and solid components of whole blood are separated, and then the liquid components are further separated into portions that are platelet-rich and platelet-poor.

Significant variability in preparation methods exists, resulting in more than 40 different products.² Some methods centrifuge only once, creating plasma that is separated from red and white blood cells, but without a huge shift in the concentration of platelets; some include white blood cells in the final preparation; and most have differing concentrations of platelets and various growth factors in the end product. Researchers have attempted to classify the various preparations by platelet concentration, inclusion or exclusion of white blood cells, and fibrin content, but no validated system yet exists. Thus, consistency in preparations is lacking.^3,4

PRP is rich not only in platelets, but also in a multitude of other growth factors. It is thought to improve healing by enhancing the body’s natural regenerative processes at the tissue level. In OA, for example, a complex balance of destructive and reparative processes is at play; PRP is thought to tip the body’s response in favor of regeneration over destruction. Similarly, chronic tendinopathy involves a process of destruction, reaction, healing, and degeneration; intervening at the correct point in this pathway with a boost to healing may help the body repair an otherwise diseased tendon.³

What does the evidence show?

Overall, basic science and preclinical research support “the promise” of PRP(strength of recommendation [SOR]: A).⁵ However, patient-centered evidence is lacking, and tremendous variability exists between studies, not only in terms of PRP preparation, but also with regard to:

• Protocol—Was ultrasound guidance used? Did the injection include needling of the tendon? What post-injection rehabilitation was followed?
• Patient population—What treatments were tried in the past? How chronic or severe was the problem?
• Study design—What was the comparison group? How were pain and function measured? Most studies have been small in size and have included various treatment modalities in addition to the PRP injection (most often PT).

Knee OA: PRP may provide short-term benefit, especially in younger patients

Researchers have conducted a number of studies evaluating PRP for knee OA.^6-12 Most have compared PRP to HA—another intra-articular injection that is plagued by mixed, limited, and poor-quality evidence. These trials have had varied results and do not consistently support PRP as superior to HA.

The most well-designed study to date demonstrated that PRP was superior to saline and as effective as HA.¹¹ In addition, the researchers found that a series of 3 PRP injections was superior to 3 injections of HA or only one injection of PRP.

One small randomized controlled trial (RCT) compared PRP injections to saline and found that PRP improved pain and function better than placebo at 6 weeks, 3 months, and 6 months; results appeared to deteriorate after that time period.⁶ Also, the findings suggested that PRP delivered the strongest benefit in younger patients who had less advanced OA.

In addition, a recent systematic review found short-term improvements in functional outcomes in patients treated with PRP injections vs those treated with HA injections and those treated with placebo.¹²

Basic science and preclinical research support “the promise” of platelet-rich plasma, but patient-centered evidence is lacking, and tremendous variability exists between studies.

But before experts can make any conclusive recommendations regarding the use of PRP for knee OA, standardized studies with larger numbers of participants and rigorous methodology must be designed. Notably, no evidence exists of significant harm resulting from PRP injection for knee OA. Therefore, given the mixed evidence in terms of efficacy, there may be a potential benefit to treatment with little negative consequence.

In 2013, the American Academy of Orthopaedic Surgeons (AAOS) stated that they were unable to recommend for or against PRP injection for patients with symptomatic OA of the knee because the evidence was inconclusive.¹³ At the same time, the AAOS was unable to recommend for or against corticosteroid injections, manual therapy, or bracing for knee OA, and recommended against HA injections.¹³ Recently, however, the American Medical Society for Sports Medicine (AMSSM) recommended that HA be used in appropriate patients with knee OA.¹⁴

Such disagreement indicates that evidence is lacking for many modalities employed in the management of knee OA, including the injection of corticosteroids, which is a frequent and generally accepted treatment. Compounding matters is that many of the original studies testing the efficacy of PRP injection in knee OA used HA injections as the comparison, and there is no agreement between AAOS and AMSSM as to its usefulness. Thus, the validity of using HA as a control is suspect.

Tendinopathies: PRP may have benefit, but more research is needed

A number of meta-analyses and systematic review articles have combined the results of studies involving PRP treatment for various tendinopathies.^3,15-17 While most found that PRP may have a benefit (although not long-lasting) and may be of use in attempts to avoid surgery or to return to a desired activity, all reported that more rigorous studies with standardized methodologies must be conducted before PRP can be conclusively recommended for any anatomic site.

Elbow epicondylitis (tennis elbow). The majority of tendinopathy studies have examined the effect of PRP on tennis elbow, although given the small study numbers (N=20-100), high risks of bias, and very different comparison groups, the data are extremely limited. Of the 4 randomized studies,^18-21 2 compared different PRP preparations to whole blood,^18,20 one compared PRP to both saline and corticosteroid,¹⁹ and one compared PRP to corticosteroid alone.²¹

The studies comparing PRP to whole blood found similar outcomes at most time points.^18,20 These studies were of extremely poor quality, and other review articles have defined whole blood as a type of PRP, so this comparison was somewhat inappropriate. One recently published meta-analysis, which included 10 studies comparing either PRP or whole blood to corticosteroid, found that PRP improved pain more than a corticosteroid.²²

The one study that included a comparison of PRP to placebo (saline) suffered from a high dropout rate, and the authors were not able to analyze the primary outcome data. At 3 months, the participants remaining in each group (PRP, saline, or corticosteroid) had similar pain and disability scores.¹⁹ Although the steroid group had improved from baseline at one month, there was no difference between the steroid group and placebo group at 3 months. The PRP group did not differ from the placebo group at any time point.

The study comparing PRP to corticosteroid alone found that PRP’s effects on pain and function exceeded those of the steroid. Specifically, the steroid group initially improved and then worsened, ending the study near their baseline pain and function scores.²¹ The PRP group, on the other hand, showed slow improvement throughout, ending the study with less pain and disability than when they started.

There is no evidence of significant harms associated with platelet-rich plasma treatment, but studies have lacked the power to detect rare but serious problems.

Patellar tendinitis (jumper’s knee). The majority of studies examining the effect of PRP on patellar tendinitis are non-randomized, non-comparative studies. Of the 2 small RCTs that were conducted, one compared PRP to extracorporeal shockwave therapy (ESWT),²³ and the other to dry needling.²⁴

In the ESWT study, there was a slight improvement in pain and function in the PRP group relative to the ESWT group at 6 and 12 months. In the other study, although the PRP group showed an improvement in recovery at 12 weeks relative to the dry needling group, there was no difference between such outcomes as pain and activity in the 2 groups at 26 weeks.

Worth noting here is that like the studies done on OA patients, the research involving patellar tendinitis also used comparative interventions (ESWT and dry needling) that lack high-quality evidence for their use. So whether these were appropriate comparisons is debatable.

Achilles tendinitis. Only one RCT (N=54) has evaluated PRP for the treatment of Achilles tendinitis.²⁵ This study, which compared PRP to saline, excluded patients who had previously completed a course of PT, yet both study groups participated in PT during the study. Although the trial found no difference between groups at any time point (both showed improvement), it was underpowered to detect any difference (positive or negative) between groups, given that most participants likely would have improved with PT anyway.²⁶

PRP has few harms or adverse effects

Most individual studies involving PRP have not reported on harms or side effects; the studies that have reported on them have generally found low rates (2%-5%) of only local, short-term adverse effects.¹⁵ One review article did find that increasing the number of PRP injections increased the rate of adverse effects; however, those effects still appeared to be mild and time-limited.¹⁰

One study reported that 33% (17/51) of patients experienced systemic adverse effects including syncope, dizziness, and nausea at the time of their PRP injection.⁶ Overall, there is no evidence of significant harms associated with PRP treatment, but available studies have lacked the power to detect rare but serious problems.

Looking to the future: Additional considerations

In order to properly evaluate this potentially promising method of care, future studies need to include appropriately chosen controls, specifically defined formulations of PRP, standardized protocols for the injection of PRP, standardized post-injection PT regimens, and patient populations that are clearly defined in terms of severity and chronicity of disease. Furthermore, studies must be rigorously designed in terms of randomization, blinding, and analysis. (Many studies done to date did not use an intention-to-treat protocol, for example). Higher-quality studies with larger numbers of participants are the only way to determine whether PRP is worth all the “buzz.”

Platelet-rich plasma is approved only for use in the operative setting to enhance bone graft handling properties. Office-based injections are an off-label use.

We should keep in mind, too, that the evidence for many of the other treatment options for both tendinopathy and knee OA are similarly problematic, and these modalities are even more widely used than PRP. Given the systemic problems associated with nonsteroidal anti-inflammatory drugs, concerns about possible tendon rupture with corticosteroid injections, and the time and compliance issues associated with PT, PRP may be a safer alternative to more traditional treatments.

An off-label use. PRP does not pass through the standard regulatory pathway of the US Food and Drug Administration (FDA). As a blood product, PRP falls under the regulatory purview of the FDA’s Center for Biologics Evaluation and Research, which has approved PRP only for use in the operative setting to enhance bone graft handling properties.²⁷ Therefore, office-based PRP injections are an off-label use of the treatment.

CASE 1 › You explain to Ms. T that PRP injections are not covered by insurance and that there is not a significant amount of evidence to indicate that an injection would appreciably improve her pain. She decides to proceed with a knee replacement and not to pursue a PRP injection.

CASE 2 › Given the time that Mr. H has invested in traditional conservative management strategies, his time away from work, and that he is not concerned with the out-of-pocket cost associated with PRP, you explain to him that there is some limited evidence that PRP might improve his symptoms. He decides that he would rather try a PRP injection than pursue surgery.

CORRESPONDENCE
Jordan White, MD, MPH, Department of Family Medicine, 111 Brewster Street, Pawtucket, RI 02860; [email protected].

CASE 1 › Ms. T is an otherwise healthy 76 year old with a history of severe osteoarthritis (OA) in her right knee. She has participated in multiple rounds of physical therapy (PT) over the last 3 years. During the past year, she received 2 intra-articular corticosteroid injections, each of which provided only 3 to 4 weeks of pain relief, and one hyaluronic acid (HA) injection, which provided no benefit whatsoever.

Today, she describes her right knee pain as an 8 out of 10 and is frustrated by her lack of symptom relief. She was planning to have a total knee replacement and is a good surgical candidate, but recently found an article regarding platelet-rich plasma (PRP) injections for knee OA. She wants your opinion as to whether she should try this approach or proceed with surgery.

CASE 2 › Mr. H is a 44-year-old, right-handed dentist who has been suffering from right lateral epicondylitis for the past year. Although he has undergone PT and has been performing exercises at home since his symptoms began, he has not noticed a significant improvement. In the last 5 months, he has been out of work a total of 8 weeks due to the pain. He received one corticosteroid injection last month, which provided no improvement in symptoms. He is not interested in surgery, as he does not want to be out of work for a prolonged period of time.

He reports that one of his friends recently received a PRP injection for lateral epicondylitis and now feels great. He is aware that PRP injections are not covered by his health insurance and says he is willing to pay out of pocket if the treatment works. He wants to know if you recommend this course of action for his elbow pain.

How would you counsel each of these patients about the use of PRP injections for pain relief from their respective orthopedic conditions?

Musculoskeletal symptoms account for 10% to 28% of patients’ complaints to primary care physicians annually.¹ Treatment of both chronic tendinopathies and knee OA—2 of the most common causes of these complaints—typically follows a stepwise approach, beginning with anti-inflammatory and pain medications in addition to PT. Patients who fail to respond to these interventions are often treated with corticosteroid injections, and, in the case of knee OA, viscosupplementation (ie, HA injections) and braces. If these therapies fail, patients are often forced to choose between an invasive surgical procedure or continued pain and limited function.

Platelet-rich plasma is thought to tip the body’s response in favor of regeneration over destruction.

A number of physicians specializing in musculoskeletal medicine have turned to prolotherapy—specifically, dextrose prolotherapy (see “Prolotherapy: Can it help your patient?” J Fam Pract. 2015;64:763-768) and platelet-rich plasma (PRP) therapy—as an alternative treatment for chronic musculoskeletal conditions.

PRP has been used to enhance surgical healing and to treat muscle strains and chondropathies. It drew a great deal of attention in the media when it was used by such high-profile professional athletes as Tiger Woods and Kobe Bryant.

Although PRP therapy is not commonly reimbursed by health insurance companies because of a lack of large, definitive studies supporting its effectiveness, patients are paying anywhere from a few hundred to a few thousand dollars out of pocket for it. They’re doing so in the hope that it will treat their chronic musculoskeletal disorders or at least delay surgical procedures.

But what can these patients reasonably expect from this therapy?

The following review of the evidence for PRP in the treatment of knee OA and tendinopathies (including elbow epicondylitis, patellar tendinitis, and Achilles tendinitis) will help you counsel patients on its appropriate use.

What is PRP?

PRP is defined as a sample of autologous blood with concentrations of platelets above baseline values.² It is made through a one- or 2-stage centrifugation process in which the liquid and solid components of whole blood are separated, and then the liquid components are further separated into portions that are platelet-rich and platelet-poor.

Significant variability in preparation methods exists, resulting in more than 40 different products.² Some methods centrifuge only once, creating plasma that is separated from red and white blood cells, but without a huge shift in the concentration of platelets; some include white blood cells in the final preparation; and most have differing concentrations of platelets and various growth factors in the end product. Researchers have attempted to classify the various preparations by platelet concentration, inclusion or exclusion of white blood cells, and fibrin content, but no validated system yet exists. Thus, consistency in preparations is lacking.^3,4

PRP is rich not only in platelets, but also in a multitude of other growth factors. It is thought to improve healing by enhancing the body’s natural regenerative processes at the tissue level. In OA, for example, a complex balance of destructive and reparative processes is at play; PRP is thought to tip the body’s response in favor of regeneration over destruction. Similarly, chronic tendinopathy involves a process of destruction, reaction, healing, and degeneration; intervening at the correct point in this pathway with a boost to healing may help the body repair an otherwise diseased tendon.³

What does the evidence show?

Overall, basic science and preclinical research support “the promise” of PRP(strength of recommendation [SOR]: A).⁵ However, patient-centered evidence is lacking, and tremendous variability exists between studies, not only in terms of PRP preparation, but also with regard to:

• Protocol—Was ultrasound guidance used? Did the injection include needling of the tendon? What post-injection rehabilitation was followed?
• Patient population—What treatments were tried in the past? How chronic or severe was the problem?
• Study design—What was the comparison group? How were pain and function measured? Most studies have been small in size and have included various treatment modalities in addition to the PRP injection (most often PT).

Knee OA: PRP may provide short-term benefit, especially in younger patients

Researchers have conducted a number of studies evaluating PRP for knee OA.^6-12 Most have compared PRP to HA—another intra-articular injection that is plagued by mixed, limited, and poor-quality evidence. These trials have had varied results and do not consistently support PRP as superior to HA.

The most well-designed study to date demonstrated that PRP was superior to saline and as effective as HA.¹¹ In addition, the researchers found that a series of 3 PRP injections was superior to 3 injections of HA or only one injection of PRP.

One small randomized controlled trial (RCT) compared PRP injections to saline and found that PRP improved pain and function better than placebo at 6 weeks, 3 months, and 6 months; results appeared to deteriorate after that time period.⁶ Also, the findings suggested that PRP delivered the strongest benefit in younger patients who had less advanced OA.

In addition, a recent systematic review found short-term improvements in functional outcomes in patients treated with PRP injections vs those treated with HA injections and those treated with placebo.¹²

Basic science and preclinical research support “the promise” of platelet-rich plasma, but patient-centered evidence is lacking, and tremendous variability exists between studies.

But before experts can make any conclusive recommendations regarding the use of PRP for knee OA, standardized studies with larger numbers of participants and rigorous methodology must be designed. Notably, no evidence exists of significant harm resulting from PRP injection for knee OA. Therefore, given the mixed evidence in terms of efficacy, there may be a potential benefit to treatment with little negative consequence.

In 2013, the American Academy of Orthopaedic Surgeons (AAOS) stated that they were unable to recommend for or against PRP injection for patients with symptomatic OA of the knee because the evidence was inconclusive.¹³ At the same time, the AAOS was unable to recommend for or against corticosteroid injections, manual therapy, or bracing for knee OA, and recommended against HA injections.¹³ Recently, however, the American Medical Society for Sports Medicine (AMSSM) recommended that HA be used in appropriate patients with knee OA.¹⁴

Such disagreement indicates that evidence is lacking for many modalities employed in the management of knee OA, including the injection of corticosteroids, which is a frequent and generally accepted treatment. Compounding matters is that many of the original studies testing the efficacy of PRP injection in knee OA used HA injections as the comparison, and there is no agreement between AAOS and AMSSM as to its usefulness. Thus, the validity of using HA as a control is suspect.

Tendinopathies: PRP may have benefit, but more research is needed

A number of meta-analyses and systematic review articles have combined the results of studies involving PRP treatment for various tendinopathies.^3,15-17 While most found that PRP may have a benefit (although not long-lasting) and may be of use in attempts to avoid surgery or to return to a desired activity, all reported that more rigorous studies with standardized methodologies must be conducted before PRP can be conclusively recommended for any anatomic site.

Elbow epicondylitis (tennis elbow). The majority of tendinopathy studies have examined the effect of PRP on tennis elbow, although given the small study numbers (N=20-100), high risks of bias, and very different comparison groups, the data are extremely limited. Of the 4 randomized studies,^18-21 2 compared different PRP preparations to whole blood,^18,20 one compared PRP to both saline and corticosteroid,¹⁹ and one compared PRP to corticosteroid alone.²¹

The studies comparing PRP to whole blood found similar outcomes at most time points.^18,20 These studies were of extremely poor quality, and other review articles have defined whole blood as a type of PRP, so this comparison was somewhat inappropriate. One recently published meta-analysis, which included 10 studies comparing either PRP or whole blood to corticosteroid, found that PRP improved pain more than a corticosteroid.²²

The one study that included a comparison of PRP to placebo (saline) suffered from a high dropout rate, and the authors were not able to analyze the primary outcome data. At 3 months, the participants remaining in each group (PRP, saline, or corticosteroid) had similar pain and disability scores.¹⁹ Although the steroid group had improved from baseline at one month, there was no difference between the steroid group and placebo group at 3 months. The PRP group did not differ from the placebo group at any time point.

The study comparing PRP to corticosteroid alone found that PRP’s effects on pain and function exceeded those of the steroid. Specifically, the steroid group initially improved and then worsened, ending the study near their baseline pain and function scores.²¹ The PRP group, on the other hand, showed slow improvement throughout, ending the study with less pain and disability than when they started.

There is no evidence of significant harms associated with platelet-rich plasma treatment, but studies have lacked the power to detect rare but serious problems.

Patellar tendinitis (jumper’s knee). The majority of studies examining the effect of PRP on patellar tendinitis are non-randomized, non-comparative studies. Of the 2 small RCTs that were conducted, one compared PRP to extracorporeal shockwave therapy (ESWT),²³ and the other to dry needling.²⁴

In the ESWT study, there was a slight improvement in pain and function in the PRP group relative to the ESWT group at 6 and 12 months. In the other study, although the PRP group showed an improvement in recovery at 12 weeks relative to the dry needling group, there was no difference between such outcomes as pain and activity in the 2 groups at 26 weeks.

Worth noting here is that like the studies done on OA patients, the research involving patellar tendinitis also used comparative interventions (ESWT and dry needling) that lack high-quality evidence for their use. So whether these were appropriate comparisons is debatable.

Achilles tendinitis. Only one RCT (N=54) has evaluated PRP for the treatment of Achilles tendinitis.²⁵ This study, which compared PRP to saline, excluded patients who had previously completed a course of PT, yet both study groups participated in PT during the study. Although the trial found no difference between groups at any time point (both showed improvement), it was underpowered to detect any difference (positive or negative) between groups, given that most participants likely would have improved with PT anyway.²⁶

PRP has few harms or adverse effects

Most individual studies involving PRP have not reported on harms or side effects; the studies that have reported on them have generally found low rates (2%-5%) of only local, short-term adverse effects.¹⁵ One review article did find that increasing the number of PRP injections increased the rate of adverse effects; however, those effects still appeared to be mild and time-limited.¹⁰

One study reported that 33% (17/51) of patients experienced systemic adverse effects including syncope, dizziness, and nausea at the time of their PRP injection.⁶ Overall, there is no evidence of significant harms associated with PRP treatment, but available studies have lacked the power to detect rare but serious problems.

Looking to the future: Additional considerations

In order to properly evaluate this potentially promising method of care, future studies need to include appropriately chosen controls, specifically defined formulations of PRP, standardized protocols for the injection of PRP, standardized post-injection PT regimens, and patient populations that are clearly defined in terms of severity and chronicity of disease. Furthermore, studies must be rigorously designed in terms of randomization, blinding, and analysis. (Many studies done to date did not use an intention-to-treat protocol, for example). Higher-quality studies with larger numbers of participants are the only way to determine whether PRP is worth all the “buzz.”

Platelet-rich plasma is approved only for use in the operative setting to enhance bone graft handling properties. Office-based injections are an off-label use.

We should keep in mind, too, that the evidence for many of the other treatment options for both tendinopathy and knee OA are similarly problematic, and these modalities are even more widely used than PRP. Given the systemic problems associated with nonsteroidal anti-inflammatory drugs, concerns about possible tendon rupture with corticosteroid injections, and the time and compliance issues associated with PT, PRP may be a safer alternative to more traditional treatments.

An off-label use. PRP does not pass through the standard regulatory pathway of the US Food and Drug Administration (FDA). As a blood product, PRP falls under the regulatory purview of the FDA’s Center for Biologics Evaluation and Research, which has approved PRP only for use in the operative setting to enhance bone graft handling properties.²⁷ Therefore, office-based PRP injections are an off-label use of the treatment.

CASE 1 › You explain to Ms. T that PRP injections are not covered by insurance and that there is not a significant amount of evidence to indicate that an injection would appreciably improve her pain. She decides to proceed with a knee replacement and not to pursue a PRP injection.

CASE 2 › Given the time that Mr. H has invested in traditional conservative management strategies, his time away from work, and that he is not concerned with the out-of-pocket cost associated with PRP, you explain to him that there is some limited evidence that PRP might improve his symptoms. He decides that he would rather try a PRP injection than pursue surgery.

CORRESPONDENCE
Jordan White, MD, MPH, Department of Family Medicine, 111 Brewster Street, Pawtucket, RI 02860; [email protected].

CASE 1 › Ms. T is an otherwise healthy 76 year old with a history of severe osteoarthritis (OA) in her right knee. She has participated in multiple rounds of physical therapy (PT) over the last 3 years. During the past year, she received 2 intra-articular corticosteroid injections, each of which provided only 3 to 4 weeks of pain relief, and one hyaluronic acid (HA) injection, which provided no benefit whatsoever.

Today, she describes her right knee pain as an 8 out of 10 and is frustrated by her lack of symptom relief. She was planning to have a total knee replacement and is a good surgical candidate, but recently found an article regarding platelet-rich plasma (PRP) injections for knee OA. She wants your opinion as to whether she should try this approach or proceed with surgery.

CASE 2 › Mr. H is a 44-year-old, right-handed dentist who has been suffering from right lateral epicondylitis for the past year. Although he has undergone PT and has been performing exercises at home since his symptoms began, he has not noticed a significant improvement. In the last 5 months, he has been out of work a total of 8 weeks due to the pain. He received one corticosteroid injection last month, which provided no improvement in symptoms. He is not interested in surgery, as he does not want to be out of work for a prolonged period of time.

He reports that one of his friends recently received a PRP injection for lateral epicondylitis and now feels great. He is aware that PRP injections are not covered by his health insurance and says he is willing to pay out of pocket if the treatment works. He wants to know if you recommend this course of action for his elbow pain.

How would you counsel each of these patients about the use of PRP injections for pain relief from their respective orthopedic conditions?

Musculoskeletal symptoms account for 10% to 28% of patients’ complaints to primary care physicians annually.¹ Treatment of both chronic tendinopathies and knee OA—2 of the most common causes of these complaints—typically follows a stepwise approach, beginning with anti-inflammatory and pain medications in addition to PT. Patients who fail to respond to these interventions are often treated with corticosteroid injections, and, in the case of knee OA, viscosupplementation (ie, HA injections) and braces. If these therapies fail, patients are often forced to choose between an invasive surgical procedure or continued pain and limited function.

Platelet-rich plasma is thought to tip the body’s response in favor of regeneration over destruction.

A number of physicians specializing in musculoskeletal medicine have turned to prolotherapy—specifically, dextrose prolotherapy (see “Prolotherapy: Can it help your patient?” J Fam Pract. 2015;64:763-768) and platelet-rich plasma (PRP) therapy—as an alternative treatment for chronic musculoskeletal conditions.

PRP has been used to enhance surgical healing and to treat muscle strains and chondropathies. It drew a great deal of attention in the media when it was used by such high-profile professional athletes as Tiger Woods and Kobe Bryant.

Although PRP therapy is not commonly reimbursed by health insurance companies because of a lack of large, definitive studies supporting its effectiveness, patients are paying anywhere from a few hundred to a few thousand dollars out of pocket for it. They’re doing so in the hope that it will treat their chronic musculoskeletal disorders or at least delay surgical procedures.

But what can these patients reasonably expect from this therapy?

The following review of the evidence for PRP in the treatment of knee OA and tendinopathies (including elbow epicondylitis, patellar tendinitis, and Achilles tendinitis) will help you counsel patients on its appropriate use.

What is PRP?

PRP is defined as a sample of autologous blood with concentrations of platelets above baseline values.² It is made through a one- or 2-stage centrifugation process in which the liquid and solid components of whole blood are separated, and then the liquid components are further separated into portions that are platelet-rich and platelet-poor.

Significant variability in preparation methods exists, resulting in more than 40 different products.² Some methods centrifuge only once, creating plasma that is separated from red and white blood cells, but without a huge shift in the concentration of platelets; some include white blood cells in the final preparation; and most have differing concentrations of platelets and various growth factors in the end product. Researchers have attempted to classify the various preparations by platelet concentration, inclusion or exclusion of white blood cells, and fibrin content, but no validated system yet exists. Thus, consistency in preparations is lacking.^3,4

PRP is rich not only in platelets, but also in a multitude of other growth factors. It is thought to improve healing by enhancing the body’s natural regenerative processes at the tissue level. In OA, for example, a complex balance of destructive and reparative processes is at play; PRP is thought to tip the body’s response in favor of regeneration over destruction. Similarly, chronic tendinopathy involves a process of destruction, reaction, healing, and degeneration; intervening at the correct point in this pathway with a boost to healing may help the body repair an otherwise diseased tendon.³

What does the evidence show?

Overall, basic science and preclinical research support “the promise” of PRP(strength of recommendation [SOR]: A).⁵ However, patient-centered evidence is lacking, and tremendous variability exists between studies, not only in terms of PRP preparation, but also with regard to:

• Protocol—Was ultrasound guidance used? Did the injection include needling of the tendon? What post-injection rehabilitation was followed?
• Patient population—What treatments were tried in the past? How chronic or severe was the problem?
• Study design—What was the comparison group? How were pain and function measured? Most studies have been small in size and have included various treatment modalities in addition to the PRP injection (most often PT).

Knee OA: PRP may provide short-term benefit, especially in younger patients

Researchers have conducted a number of studies evaluating PRP for knee OA.^6-12 Most have compared PRP to HA—another intra-articular injection that is plagued by mixed, limited, and poor-quality evidence. These trials have had varied results and do not consistently support PRP as superior to HA.

The most well-designed study to date demonstrated that PRP was superior to saline and as effective as HA.¹¹ In addition, the researchers found that a series of 3 PRP injections was superior to 3 injections of HA or only one injection of PRP.

One small randomized controlled trial (RCT) compared PRP injections to saline and found that PRP improved pain and function better than placebo at 6 weeks, 3 months, and 6 months; results appeared to deteriorate after that time period.⁶ Also, the findings suggested that PRP delivered the strongest benefit in younger patients who had less advanced OA.

In addition, a recent systematic review found short-term improvements in functional outcomes in patients treated with PRP injections vs those treated with HA injections and those treated with placebo.¹²

Basic science and preclinical research support “the promise” of platelet-rich plasma, but patient-centered evidence is lacking, and tremendous variability exists between studies.

But before experts can make any conclusive recommendations regarding the use of PRP for knee OA, standardized studies with larger numbers of participants and rigorous methodology must be designed. Notably, no evidence exists of significant harm resulting from PRP injection for knee OA. Therefore, given the mixed evidence in terms of efficacy, there may be a potential benefit to treatment with little negative consequence.

In 2013, the American Academy of Orthopaedic Surgeons (AAOS) stated that they were unable to recommend for or against PRP injection for patients with symptomatic OA of the knee because the evidence was inconclusive.¹³ At the same time, the AAOS was unable to recommend for or against corticosteroid injections, manual therapy, or bracing for knee OA, and recommended against HA injections.¹³ Recently, however, the American Medical Society for Sports Medicine (AMSSM) recommended that HA be used in appropriate patients with knee OA.¹⁴

Such disagreement indicates that evidence is lacking for many modalities employed in the management of knee OA, including the injection of corticosteroids, which is a frequent and generally accepted treatment. Compounding matters is that many of the original studies testing the efficacy of PRP injection in knee OA used HA injections as the comparison, and there is no agreement between AAOS and AMSSM as to its usefulness. Thus, the validity of using HA as a control is suspect.

Tendinopathies: PRP may have benefit, but more research is needed

A number of meta-analyses and systematic review articles have combined the results of studies involving PRP treatment for various tendinopathies.^3,15-17 While most found that PRP may have a benefit (although not long-lasting) and may be of use in attempts to avoid surgery or to return to a desired activity, all reported that more rigorous studies with standardized methodologies must be conducted before PRP can be conclusively recommended for any anatomic site.

Elbow epicondylitis (tennis elbow). The majority of tendinopathy studies have examined the effect of PRP on tennis elbow, although given the small study numbers (N=20-100), high risks of bias, and very different comparison groups, the data are extremely limited. Of the 4 randomized studies,^18-21 2 compared different PRP preparations to whole blood,^18,20 one compared PRP to both saline and corticosteroid,¹⁹ and one compared PRP to corticosteroid alone.²¹

The studies comparing PRP to whole blood found similar outcomes at most time points.^18,20 These studies were of extremely poor quality, and other review articles have defined whole blood as a type of PRP, so this comparison was somewhat inappropriate. One recently published meta-analysis, which included 10 studies comparing either PRP or whole blood to corticosteroid, found that PRP improved pain more than a corticosteroid.²²

The one study that included a comparison of PRP to placebo (saline) suffered from a high dropout rate, and the authors were not able to analyze the primary outcome data. At 3 months, the participants remaining in each group (PRP, saline, or corticosteroid) had similar pain and disability scores.¹⁹ Although the steroid group had improved from baseline at one month, there was no difference between the steroid group and placebo group at 3 months. The PRP group did not differ from the placebo group at any time point.

The study comparing PRP to corticosteroid alone found that PRP’s effects on pain and function exceeded those of the steroid. Specifically, the steroid group initially improved and then worsened, ending the study near their baseline pain and function scores.²¹ The PRP group, on the other hand, showed slow improvement throughout, ending the study with less pain and disability than when they started.

There is no evidence of significant harms associated with platelet-rich plasma treatment, but studies have lacked the power to detect rare but serious problems.

Patellar tendinitis (jumper’s knee). The majority of studies examining the effect of PRP on patellar tendinitis are non-randomized, non-comparative studies. Of the 2 small RCTs that were conducted, one compared PRP to extracorporeal shockwave therapy (ESWT),²³ and the other to dry needling.²⁴

In the ESWT study, there was a slight improvement in pain and function in the PRP group relative to the ESWT group at 6 and 12 months. In the other study, although the PRP group showed an improvement in recovery at 12 weeks relative to the dry needling group, there was no difference between such outcomes as pain and activity in the 2 groups at 26 weeks.

Worth noting here is that like the studies done on OA patients, the research involving patellar tendinitis also used comparative interventions (ESWT and dry needling) that lack high-quality evidence for their use. So whether these were appropriate comparisons is debatable.

Achilles tendinitis. Only one RCT (N=54) has evaluated PRP for the treatment of Achilles tendinitis.²⁵ This study, which compared PRP to saline, excluded patients who had previously completed a course of PT, yet both study groups participated in PT during the study. Although the trial found no difference between groups at any time point (both showed improvement), it was underpowered to detect any difference (positive or negative) between groups, given that most participants likely would have improved with PT anyway.²⁶

PRP has few harms or adverse effects

Most individual studies involving PRP have not reported on harms or side effects; the studies that have reported on them have generally found low rates (2%-5%) of only local, short-term adverse effects.¹⁵ One review article did find that increasing the number of PRP injections increased the rate of adverse effects; however, those effects still appeared to be mild and time-limited.¹⁰

One study reported that 33% (17/51) of patients experienced systemic adverse effects including syncope, dizziness, and nausea at the time of their PRP injection.⁶ Overall, there is no evidence of significant harms associated with PRP treatment, but available studies have lacked the power to detect rare but serious problems.

Looking to the future: Additional considerations

In order to properly evaluate this potentially promising method of care, future studies need to include appropriately chosen controls, specifically defined formulations of PRP, standardized protocols for the injection of PRP, standardized post-injection PT regimens, and patient populations that are clearly defined in terms of severity and chronicity of disease. Furthermore, studies must be rigorously designed in terms of randomization, blinding, and analysis. (Many studies done to date did not use an intention-to-treat protocol, for example). Higher-quality studies with larger numbers of participants are the only way to determine whether PRP is worth all the “buzz.”

Platelet-rich plasma is approved only for use in the operative setting to enhance bone graft handling properties. Office-based injections are an off-label use.

We should keep in mind, too, that the evidence for many of the other treatment options for both tendinopathy and knee OA are similarly problematic, and these modalities are even more widely used than PRP. Given the systemic problems associated with nonsteroidal anti-inflammatory drugs, concerns about possible tendon rupture with corticosteroid injections, and the time and compliance issues associated with PT, PRP may be a safer alternative to more traditional treatments.

An off-label use. PRP does not pass through the standard regulatory pathway of the US Food and Drug Administration (FDA). As a blood product, PRP falls under the regulatory purview of the FDA’s Center for Biologics Evaluation and Research, which has approved PRP only for use in the operative setting to enhance bone graft handling properties.²⁷ Therefore, office-based PRP injections are an off-label use of the treatment.

CASE 1 › You explain to Ms. T that PRP injections are not covered by insurance and that there is not a significant amount of evidence to indicate that an injection would appreciably improve her pain. She decides to proceed with a knee replacement and not to pursue a PRP injection.

CASE 2 › Given the time that Mr. H has invested in traditional conservative management strategies, his time away from work, and that he is not concerned with the out-of-pocket cost associated with PRP, you explain to him that there is some limited evidence that PRP might improve his symptoms. He decides that he would rather try a PRP injection than pursue surgery.

CORRESPONDENCE
Jordan White, MD, MPH, Department of Family Medicine, 111 Brewster Street, Pawtucket, RI 02860; [email protected].

More than 5 million Americans are living with paralysis, and for nearly one in 4 of them the cause is spinal cord injury or disease (SCI/D).¹ More common than multiple sclerosis (17%) as a cause for the loss of movement, SCI/D is second only to stroke (29%).¹

The percentage of people living with paralysis due to SCI/D is increasing, partly because the population is aging and partly because management of infections has improved. Prior to the 1970s, life expectancy for people with SCI/D was significantly shortened, largely because of urologic and respiratory infections. But improved bladder management, in particular, has increased life expectancy—especially for the least severely injured.² Respiratory diseases and septicemia remain the leading causes of death, but with increased longevity, other causes, such as endocrine, metabolic and nutritional diseases, accidents, nervous system diseases, and musculoskeletal disorders, are becoming increasingly common.^2,3

Primary care’s pivotal role. Given the size of the population affected by SCI/D and the increase in life expectancy, family physicians (FPs) are more likely than ever before to care for these patients, most of whom have highly specific needs. However, little information about the primary care of patients with SCI/D exists. This patient population tends to consume a relatively large share of practices’ resources because of high case complexity.⁴

A recent Canadian report confirms our clinical experience that FPs report knowledge gaps in the area of SCI/D care, yet the same report found that 90% of people with SCI/D identify FPs as their “regular doctors.”⁵ Although a large number of patients with SCI/D identify their physiatrist as their primary care physician (PCP), one study reported that fewer than half of physiatrists are willing to assume that role.⁶ And while more than half of all patients with SCI/D have both specialists and PCPs involved in their care,⁵ communication breakdowns are a concern for patients receiving medical and rehabilitative direction from multiple health care professionals.

Below we take a closer look at the distinct patient populations affected by SCI/D, summarize several clinical conditions that contribute to hospitalization, and provide clinical management recommendations (TABLE^7-26).

2 patient populations, one diagnosis

Paralysis due to spinal trauma occurs predominantly in non-Hispanic white and black males because of vehicular accidents, falls, violence, and sports.² The mean age of injury has increased from 29 years during the 1970s to 42 years since 2010.² However, this calculated average is misleading because there is an emerging bimodal distribution of people injured during early adulthood and a new increase in older adults injured primarily because of falls.²⁷ In addition to those injured traumatically, a broader cohort of approximately 1 million patients represents a largely undefined group of people with paralysis due to diseases such as spinal stenosis, cancer, infection, multiple sclerosis, or other non-traumatic causes.

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high—up to 50%—for people with spinal cord injury/disease.

As a result, the population with SCI/D is comprised primarily of young adult males who have relatively few chronic medical conditions at the time of their injury and age with SCI/D, and older patients who are more likely to have already developed chronic medical conditions by the time of their SCI/D. Approximately 60% of SCI/Ds result in tetraplegia (ie, 4 limbs affected), although approximately two-thirds are incomplete, meaning that patients have some residual motor or sensory function below the level of injury.² Not surprisingly, the level and severity of SCI/D impact life expectancy inversely and lifetime financial costs directly.

High health care utilization. Morbidity data largely parallel mortality data, often resulting in high health care utilization and cost among SCI/D patients.²⁸ In a recent prospective observational study of nearly 1000 people with new traumatic SCI, 36.2% were rehospitalized at least once and 12.5% were rehospitalized at least twice during the 12-month period after discharge following injury.²⁹

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high (36%-50%) for people with SCI/D.^29,30 The leading causes of rehospitalization—pneumonia, urinary tract infection (UTI), and pressure ulcers²⁹—have not changed over the years and persist over the lifetime of individuals with SCI/D.³⁰

Take steps to prevent pneumonia, other respiratory complications

Many people with SCI/D are at high risk for respiratory complications because of their weakened respiratory muscles. This is particularly true for individuals who have injuries occurring above T10; those with injuries that are high on the spinal cord have the highest complication risk.^7,8 In fact, pneumonia, atelectasis, and other respiratory complications are the leading causes of mortality in patients with tetraplegia, occurring in 40% to 70% of these patients.⁷

The diaphragm, innervated by the phrenic nerve (C3-C5), is the primary muscle of inspiration. Accessory muscles of inspiration include the scalenes (C5-C8), sternocleidomastoid and trapezius (C1-C4), and intercostals (T1-T11); whereas forced exhalation (cough) occurs with contraction of the abdominals (T5-T12).⁹ Diminished inspiration in individuals with higher level lesions can lead to microatelectasis, dyspnea with exertion, and even respiratory insufficiency.

In SCI/D above T8, weakened expiration can severely decrease cough effectiveness and secretion clearance, increasing susceptibility to lower respiratory tract infections. In addition, experts have described asthma-like disorders of airway function, particularly in those with higher lesions, due to unopposed parasympathetic innervation of respiratory smooth muscle.¹⁰

Use general population guidelines to target antibiotic therapy, as guidelines validated for use in the spinal cord injury/disease population don't exist.

Management of this neurogenic pulmonary dysfunction after SCI/D relies on extensive preventive measures, including positioning and postural changes, breathing techniques, coughing (assisted for patients with tetraplegia), postural drainage, chest compression and percussion, and suctioning to avoid atelectasis, aspiration, and pneumonia. Ensure that patients receive influenza and pneumococcal vaccinations, and encourage smoking cessation. Obtain a chest x-ray if the patient demonstrates a decrease in respiratory function, deteriorating vital signs, reduced vital capacity, an increase in subjective dyspnea, or a change in sputum quantity. Treat respiratory infections early and aggressively,^7-10 and strongly consider inpatient management because of the high risk of respiratory failure.

Pneumococcus is the most common cause of respiratory infections, although up to 21% of cases of community-acquired pneumonia in patients with SCI/D are caused by Pseudomonas.^11-13 Avoid the use of antibiotics in patients who do not have signs or symptoms of a respiratory infection to minimize the development of resistant organisms. Target antibiotic therapy as per general population guidelines, as guidelines validated for use in the population with SCI/D do not currently exist.^7,11

Be alert for UTIs—typical signs, symptoms don’t apply

The bladder receives innervation from S2 to S4 via the hypogastric, pudendal, and pelvic nerves. As such, the vast majority—70% to 84%—of patients with SCI/D report some degree of bladder dysfunction.¹⁴ Generally, SCI/D contributes to a combination of a failure to empty the bladder and a failure to store urine. The former is more frequent and the latter occurs more often in people with bladder outlet flaccidity, which usually occurs with low injury, such as that of the lumbar spine.¹⁴

The majority of people with SCI/D who are unable to empty their bladder require the use of some type of bladder catheter, either intermittent, indwelling (urethral or suprapubic), or condom. The choice of bladder management technique depends on gender, hand function, body habitus, caregiver assistance, and medical comorbidities. People with SCI/D are at greater risk for bladder and renal stones, UTI, vesicoureteral reflux, and bladder cancer.^15,16 That said, the risk of bladder and renal stones declines somewhat after the first 6 months following an injury due to an immobility-induced loss of calcium.

One can't rely on the typical UTI symptoms of dysuria and increased urinary frequency in this patient population.

Patients with SCI/D are often found to have bacteruria and even pyuria, and although they are at high risk for recurrent UTIs, these can be difficult to diagnose because signs and symptoms may differ from those seen in people with neurologically intact bladders. Symptomatic UTIs may present with fever, hematuria, abdominal discomfort, and/or increased spasticity, among other symptoms. They may cause increased bouts of autonomic dysreflexia, malaise, or a change in functional status. One cannot rely on the typical symptoms of dysuria and increased urinary frequency in this patient population. Further, the Infectious Diseases Society of America (IDSA) states that cloudy or foul-smelling urine in adults with catheters is not a symptom or sign mandating treatment.¹⁷

Because there is a lack of consensus as to what constitutes UTI symptoms in patients with SCI/D, PCPs need to be aware of changes from baseline in patients; these, combined with urine dip and culture results, should guide initiation of treatment.¹⁶

Prophylactic antibiotics have no role in the prevention of UTIs in patients with SCI/D. The minimal benefits associated with prophylaxis are outweighed by the risks of increased bacterial resistance to antibiotics. Research shows no significant benefit associated with the use of non-antibiotic prophylaxis, including the use of cranberry products and mannose, but further studies are needed in this patient population.¹⁸

Focus on bowel function; it correlates with quality of life

Bowel dysfunction is nearly universal in patients with SCI/D. The enteric nervous system is modulated via the sympathetic, parasympathetic, and somatic systems, and intrinsic control occurs via the myenteric and submucosal plexi. The loss of volitional control of defecation can result in prolonged transit time, reduced colonic motility, fecal incontinence, and difficulty with evacuation.

Because bowel care and function are highly correlated with quality of life,¹⁹ recommend bowel emptying every day or every other day, as well as adequate fiber in the diet, intake of fluids, stool softeners, bulk forming agents, contact irritants (eg, bisacodyl), and prokinetic agents to achieve optimal bowel care.

Prevent and treat pressure ulcers whenever possible

Fertility is often unaffected in women with spinal cord injury/disease, so routine discussions about contraception in those who are sexually active are imperative.

Accompanying the paralysis associated with SCI/D is often some degree of sensory loss of pain, light touch, temperature, and/or proprioception. The combination of insensate skin, immobility, and sarcopenia with resultant body composition changes places individuals with SCI/D at high risk for skin breakdown.^21,22 Blood flow and oxygen tension at the skin surface are also decreased in patients with SCI/D compared to those without, further contributing to the problem.^21,23 Increased latency from the time of injury correlates with increased likelihood of pressure ulcer development.^21,22,24

External risk factors for pressure ulcers include prolonged pressure exposure, or intense pressure over a short period, shear forces, poor nutrition, smoking, moisture, and immobility. The incidence of pressure ulcers in patients with SCI/D is 25% to 66%, compared with 0.38% in the general population.^21,22 Research indicates that US hospitals spend $11 billion annually on the treatment of the condition.²²

To minimize pressure ulcers in this population, perform a risk assessment, using, for example, the Spinal Cord Injury Pressure Ulcer Scale-Acute (SCIPUS-A) available at https://www.scireproject.com/outcome-measures-new/spinal-cord-injury-pressure-ulcer-scale-acute-scipus. In addition, recommend that patients use pressure redistribution surfaces for beds and wheelchairs, turn while in bed, perform frequent (approximately every 15-30 minutes) pressure reliefs, exercise or move regularly, and that they or a caregiver inspect the skin daily. If pressure ulcers do occur, start treatment immediately and document the stage of the ulcer.

Ensure that screening efforts go beyond what’s standard

Preventive care for patients with SCI/D is similar in many ways to that recommended for the general population. Screening for colorectal cancer,³¹ cervical cancer, and breast cancer³² should follow the same evidence-based intervals and age ranges suggested by groups such as the US Preventive Services Task Force (USPSTF). The only difference is to give special consideration to patients’ physical limitations and the set-up of exam rooms when scheduling and conducting procedures, such as Pap smears, colonoscopies, and mammograms.^33,34

Bladder cancer. Because of the high risk for bladder cancer (ie, squamous cell carcinoma, as opposed to the more common transitional cell carcinoma) in this population, experts recommend annual cystoscopy for bladder cancer surveillance in patients who have had indwelling catheters for more than 5 to 10 years.³⁵

Osteoporosis. Screening for osteoporosis is another preventive health area in which recommendations differ from those addressing the general population. Paralysis contributes to a decrease in mechanical stress on bone and to accelerated bone loss, and, thus, to osteoporosis.³⁶

In patients with SCI/D, osteoporosis affects primarily weight-bearing areas below the injured lesion, such as the distal femur and proximal tibia. Fractures in patients with SCI/D may occur during minor trauma (eg, during transfers from wheelchair to bed). Although screening and treatment guidelines for osteoporosis in patients with SCI/D are not established, most experts recommend early screening and early and aggressive treatment.³⁶

Male fertility is usually profoundly affected by spinal cord injury/disease; patients and their partners who are interested in having children will require specialized interventions.

Depression reportedly occurs more frequently in individuals with SCI/D than in the general population,^37,38 affecting adjustment, quality of life, and social, behavioral, and physical functioning. In light of this, it’s advisable to use screening tools, such as The Patient Health Questionnaire (PHQ)-9, routinely.³⁹

Sexuality and sexual function are often adversely affected in both men and women with SCI/D. Loss of sensation in the sexual organs, combined with difficulty with positioning and mobility and bowel and bladder dysfunction, contribute not only to sexual dysfunction, but to lower self-esteem and altered body image.⁴⁰

It is important to remember that fertility is often unaffected in women, so routine discussions about contraception with women who have SCI/D and who are sexually active are imperative. At the same time, male fertility is usually profoundly affected by SCI/D; patients and their partners who are interested in having children will require specialized interventions. Address sexuality and fertility during primary care visits and refer patients to counseling or specialists as necessary.^41-43

SCI/D requires a whole-person approach

The care of individuals with SCI/D requires a holistic approach that takes into consideration physical, psychological, environmental, and interpersonal factors^44,45 and involves ongoing support from a variety of specialists. FPs, with their whole-person orientation, can be instrumental in ensuring the successful rehabilitation of patients affected by SCI/D, and in helping individuals attain, preserve, and enhance their health and well-being.

CORRESPONDENCE
Ranit Mishori, MD, MHS, FAAFP, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Pre-clinical Building GB-01D, Washington, DC 20007; [email protected].

More than 5 million Americans are living with paralysis, and for nearly one in 4 of them the cause is spinal cord injury or disease (SCI/D).¹ More common than multiple sclerosis (17%) as a cause for the loss of movement, SCI/D is second only to stroke (29%).¹

The percentage of people living with paralysis due to SCI/D is increasing, partly because the population is aging and partly because management of infections has improved. Prior to the 1970s, life expectancy for people with SCI/D was significantly shortened, largely because of urologic and respiratory infections. But improved bladder management, in particular, has increased life expectancy—especially for the least severely injured.² Respiratory diseases and septicemia remain the leading causes of death, but with increased longevity, other causes, such as endocrine, metabolic and nutritional diseases, accidents, nervous system diseases, and musculoskeletal disorders, are becoming increasingly common.^2,3

Primary care’s pivotal role. Given the size of the population affected by SCI/D and the increase in life expectancy, family physicians (FPs) are more likely than ever before to care for these patients, most of whom have highly specific needs. However, little information about the primary care of patients with SCI/D exists. This patient population tends to consume a relatively large share of practices’ resources because of high case complexity.⁴

A recent Canadian report confirms our clinical experience that FPs report knowledge gaps in the area of SCI/D care, yet the same report found that 90% of people with SCI/D identify FPs as their “regular doctors.”⁵ Although a large number of patients with SCI/D identify their physiatrist as their primary care physician (PCP), one study reported that fewer than half of physiatrists are willing to assume that role.⁶ And while more than half of all patients with SCI/D have both specialists and PCPs involved in their care,⁵ communication breakdowns are a concern for patients receiving medical and rehabilitative direction from multiple health care professionals.

Below we take a closer look at the distinct patient populations affected by SCI/D, summarize several clinical conditions that contribute to hospitalization, and provide clinical management recommendations (TABLE^7-26).

2 patient populations, one diagnosis

Paralysis due to spinal trauma occurs predominantly in non-Hispanic white and black males because of vehicular accidents, falls, violence, and sports.² The mean age of injury has increased from 29 years during the 1970s to 42 years since 2010.² However, this calculated average is misleading because there is an emerging bimodal distribution of people injured during early adulthood and a new increase in older adults injured primarily because of falls.²⁷ In addition to those injured traumatically, a broader cohort of approximately 1 million patients represents a largely undefined group of people with paralysis due to diseases such as spinal stenosis, cancer, infection, multiple sclerosis, or other non-traumatic causes.

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high—up to 50%—for people with spinal cord injury/disease.

As a result, the population with SCI/D is comprised primarily of young adult males who have relatively few chronic medical conditions at the time of their injury and age with SCI/D, and older patients who are more likely to have already developed chronic medical conditions by the time of their SCI/D. Approximately 60% of SCI/Ds result in tetraplegia (ie, 4 limbs affected), although approximately two-thirds are incomplete, meaning that patients have some residual motor or sensory function below the level of injury.² Not surprisingly, the level and severity of SCI/D impact life expectancy inversely and lifetime financial costs directly.

High health care utilization. Morbidity data largely parallel mortality data, often resulting in high health care utilization and cost among SCI/D patients.²⁸ In a recent prospective observational study of nearly 1000 people with new traumatic SCI, 36.2% were rehospitalized at least once and 12.5% were rehospitalized at least twice during the 12-month period after discharge following injury.²⁹

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high (36%-50%) for people with SCI/D.^29,30 The leading causes of rehospitalization—pneumonia, urinary tract infection (UTI), and pressure ulcers²⁹—have not changed over the years and persist over the lifetime of individuals with SCI/D.³⁰

Take steps to prevent pneumonia, other respiratory complications

Many people with SCI/D are at high risk for respiratory complications because of their weakened respiratory muscles. This is particularly true for individuals who have injuries occurring above T10; those with injuries that are high on the spinal cord have the highest complication risk.^7,8 In fact, pneumonia, atelectasis, and other respiratory complications are the leading causes of mortality in patients with tetraplegia, occurring in 40% to 70% of these patients.⁷

The diaphragm, innervated by the phrenic nerve (C3-C5), is the primary muscle of inspiration. Accessory muscles of inspiration include the scalenes (C5-C8), sternocleidomastoid and trapezius (C1-C4), and intercostals (T1-T11); whereas forced exhalation (cough) occurs with contraction of the abdominals (T5-T12).⁹ Diminished inspiration in individuals with higher level lesions can lead to microatelectasis, dyspnea with exertion, and even respiratory insufficiency.

In SCI/D above T8, weakened expiration can severely decrease cough effectiveness and secretion clearance, increasing susceptibility to lower respiratory tract infections. In addition, experts have described asthma-like disorders of airway function, particularly in those with higher lesions, due to unopposed parasympathetic innervation of respiratory smooth muscle.¹⁰

Use general population guidelines to target antibiotic therapy, as guidelines validated for use in the spinal cord injury/disease population don't exist.

Management of this neurogenic pulmonary dysfunction after SCI/D relies on extensive preventive measures, including positioning and postural changes, breathing techniques, coughing (assisted for patients with tetraplegia), postural drainage, chest compression and percussion, and suctioning to avoid atelectasis, aspiration, and pneumonia. Ensure that patients receive influenza and pneumococcal vaccinations, and encourage smoking cessation. Obtain a chest x-ray if the patient demonstrates a decrease in respiratory function, deteriorating vital signs, reduced vital capacity, an increase in subjective dyspnea, or a change in sputum quantity. Treat respiratory infections early and aggressively,^7-10 and strongly consider inpatient management because of the high risk of respiratory failure.

Pneumococcus is the most common cause of respiratory infections, although up to 21% of cases of community-acquired pneumonia in patients with SCI/D are caused by Pseudomonas.^11-13 Avoid the use of antibiotics in patients who do not have signs or symptoms of a respiratory infection to minimize the development of resistant organisms. Target antibiotic therapy as per general population guidelines, as guidelines validated for use in the population with SCI/D do not currently exist.^7,11

Be alert for UTIs—typical signs, symptoms don’t apply

The bladder receives innervation from S2 to S4 via the hypogastric, pudendal, and pelvic nerves. As such, the vast majority—70% to 84%—of patients with SCI/D report some degree of bladder dysfunction.¹⁴ Generally, SCI/D contributes to a combination of a failure to empty the bladder and a failure to store urine. The former is more frequent and the latter occurs more often in people with bladder outlet flaccidity, which usually occurs with low injury, such as that of the lumbar spine.¹⁴

The majority of people with SCI/D who are unable to empty their bladder require the use of some type of bladder catheter, either intermittent, indwelling (urethral or suprapubic), or condom. The choice of bladder management technique depends on gender, hand function, body habitus, caregiver assistance, and medical comorbidities. People with SCI/D are at greater risk for bladder and renal stones, UTI, vesicoureteral reflux, and bladder cancer.^15,16 That said, the risk of bladder and renal stones declines somewhat after the first 6 months following an injury due to an immobility-induced loss of calcium.

One can't rely on the typical UTI symptoms of dysuria and increased urinary frequency in this patient population.

Patients with SCI/D are often found to have bacteruria and even pyuria, and although they are at high risk for recurrent UTIs, these can be difficult to diagnose because signs and symptoms may differ from those seen in people with neurologically intact bladders. Symptomatic UTIs may present with fever, hematuria, abdominal discomfort, and/or increased spasticity, among other symptoms. They may cause increased bouts of autonomic dysreflexia, malaise, or a change in functional status. One cannot rely on the typical symptoms of dysuria and increased urinary frequency in this patient population. Further, the Infectious Diseases Society of America (IDSA) states that cloudy or foul-smelling urine in adults with catheters is not a symptom or sign mandating treatment.¹⁷

Because there is a lack of consensus as to what constitutes UTI symptoms in patients with SCI/D, PCPs need to be aware of changes from baseline in patients; these, combined with urine dip and culture results, should guide initiation of treatment.¹⁶

Prophylactic antibiotics have no role in the prevention of UTIs in patients with SCI/D. The minimal benefits associated with prophylaxis are outweighed by the risks of increased bacterial resistance to antibiotics. Research shows no significant benefit associated with the use of non-antibiotic prophylaxis, including the use of cranberry products and mannose, but further studies are needed in this patient population.¹⁸

Focus on bowel function; it correlates with quality of life

Bowel dysfunction is nearly universal in patients with SCI/D. The enteric nervous system is modulated via the sympathetic, parasympathetic, and somatic systems, and intrinsic control occurs via the myenteric and submucosal plexi. The loss of volitional control of defecation can result in prolonged transit time, reduced colonic motility, fecal incontinence, and difficulty with evacuation.

Because bowel care and function are highly correlated with quality of life,¹⁹ recommend bowel emptying every day or every other day, as well as adequate fiber in the diet, intake of fluids, stool softeners, bulk forming agents, contact irritants (eg, bisacodyl), and prokinetic agents to achieve optimal bowel care.

Prevent and treat pressure ulcers whenever possible

Fertility is often unaffected in women with spinal cord injury/disease, so routine discussions about contraception in those who are sexually active are imperative.

Accompanying the paralysis associated with SCI/D is often some degree of sensory loss of pain, light touch, temperature, and/or proprioception. The combination of insensate skin, immobility, and sarcopenia with resultant body composition changes places individuals with SCI/D at high risk for skin breakdown.^21,22 Blood flow and oxygen tension at the skin surface are also decreased in patients with SCI/D compared to those without, further contributing to the problem.^21,23 Increased latency from the time of injury correlates with increased likelihood of pressure ulcer development.^21,22,24

External risk factors for pressure ulcers include prolonged pressure exposure, or intense pressure over a short period, shear forces, poor nutrition, smoking, moisture, and immobility. The incidence of pressure ulcers in patients with SCI/D is 25% to 66%, compared with 0.38% in the general population.^21,22 Research indicates that US hospitals spend $11 billion annually on the treatment of the condition.²²

To minimize pressure ulcers in this population, perform a risk assessment, using, for example, the Spinal Cord Injury Pressure Ulcer Scale-Acute (SCIPUS-A) available at https://www.scireproject.com/outcome-measures-new/spinal-cord-injury-pressure-ulcer-scale-acute-scipus. In addition, recommend that patients use pressure redistribution surfaces for beds and wheelchairs, turn while in bed, perform frequent (approximately every 15-30 minutes) pressure reliefs, exercise or move regularly, and that they or a caregiver inspect the skin daily. If pressure ulcers do occur, start treatment immediately and document the stage of the ulcer.

Ensure that screening efforts go beyond what’s standard

Preventive care for patients with SCI/D is similar in many ways to that recommended for the general population. Screening for colorectal cancer,³¹ cervical cancer, and breast cancer³² should follow the same evidence-based intervals and age ranges suggested by groups such as the US Preventive Services Task Force (USPSTF). The only difference is to give special consideration to patients’ physical limitations and the set-up of exam rooms when scheduling and conducting procedures, such as Pap smears, colonoscopies, and mammograms.^33,34

Bladder cancer. Because of the high risk for bladder cancer (ie, squamous cell carcinoma, as opposed to the more common transitional cell carcinoma) in this population, experts recommend annual cystoscopy for bladder cancer surveillance in patients who have had indwelling catheters for more than 5 to 10 years.³⁵

Osteoporosis. Screening for osteoporosis is another preventive health area in which recommendations differ from those addressing the general population. Paralysis contributes to a decrease in mechanical stress on bone and to accelerated bone loss, and, thus, to osteoporosis.³⁶

In patients with SCI/D, osteoporosis affects primarily weight-bearing areas below the injured lesion, such as the distal femur and proximal tibia. Fractures in patients with SCI/D may occur during minor trauma (eg, during transfers from wheelchair to bed). Although screening and treatment guidelines for osteoporosis in patients with SCI/D are not established, most experts recommend early screening and early and aggressive treatment.³⁶

Male fertility is usually profoundly affected by spinal cord injury/disease; patients and their partners who are interested in having children will require specialized interventions.

Depression reportedly occurs more frequently in individuals with SCI/D than in the general population,^37,38 affecting adjustment, quality of life, and social, behavioral, and physical functioning. In light of this, it’s advisable to use screening tools, such as The Patient Health Questionnaire (PHQ)-9, routinely.³⁹

Sexuality and sexual function are often adversely affected in both men and women with SCI/D. Loss of sensation in the sexual organs, combined with difficulty with positioning and mobility and bowel and bladder dysfunction, contribute not only to sexual dysfunction, but to lower self-esteem and altered body image.⁴⁰

It is important to remember that fertility is often unaffected in women, so routine discussions about contraception with women who have SCI/D and who are sexually active are imperative. At the same time, male fertility is usually profoundly affected by SCI/D; patients and their partners who are interested in having children will require specialized interventions. Address sexuality and fertility during primary care visits and refer patients to counseling or specialists as necessary.^41-43

SCI/D requires a whole-person approach

The care of individuals with SCI/D requires a holistic approach that takes into consideration physical, psychological, environmental, and interpersonal factors^44,45 and involves ongoing support from a variety of specialists. FPs, with their whole-person orientation, can be instrumental in ensuring the successful rehabilitation of patients affected by SCI/D, and in helping individuals attain, preserve, and enhance their health and well-being.

CORRESPONDENCE
Ranit Mishori, MD, MHS, FAAFP, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Pre-clinical Building GB-01D, Washington, DC 20007; [email protected].

More than 5 million Americans are living with paralysis, and for nearly one in 4 of them the cause is spinal cord injury or disease (SCI/D).¹ More common than multiple sclerosis (17%) as a cause for the loss of movement, SCI/D is second only to stroke (29%).¹

The percentage of people living with paralysis due to SCI/D is increasing, partly because the population is aging and partly because management of infections has improved. Prior to the 1970s, life expectancy for people with SCI/D was significantly shortened, largely because of urologic and respiratory infections. But improved bladder management, in particular, has increased life expectancy—especially for the least severely injured.² Respiratory diseases and septicemia remain the leading causes of death, but with increased longevity, other causes, such as endocrine, metabolic and nutritional diseases, accidents, nervous system diseases, and musculoskeletal disorders, are becoming increasingly common.^2,3

Primary care’s pivotal role. Given the size of the population affected by SCI/D and the increase in life expectancy, family physicians (FPs) are more likely than ever before to care for these patients, most of whom have highly specific needs. However, little information about the primary care of patients with SCI/D exists. This patient population tends to consume a relatively large share of practices’ resources because of high case complexity.⁴

A recent Canadian report confirms our clinical experience that FPs report knowledge gaps in the area of SCI/D care, yet the same report found that 90% of people with SCI/D identify FPs as their “regular doctors.”⁵ Although a large number of patients with SCI/D identify their physiatrist as their primary care physician (PCP), one study reported that fewer than half of physiatrists are willing to assume that role.⁶ And while more than half of all patients with SCI/D have both specialists and PCPs involved in their care,⁵ communication breakdowns are a concern for patients receiving medical and rehabilitative direction from multiple health care professionals.

Below we take a closer look at the distinct patient populations affected by SCI/D, summarize several clinical conditions that contribute to hospitalization, and provide clinical management recommendations (TABLE^7-26).

2 patient populations, one diagnosis

Paralysis due to spinal trauma occurs predominantly in non-Hispanic white and black males because of vehicular accidents, falls, violence, and sports.² The mean age of injury has increased from 29 years during the 1970s to 42 years since 2010.² However, this calculated average is misleading because there is an emerging bimodal distribution of people injured during early adulthood and a new increase in older adults injured primarily because of falls.²⁷ In addition to those injured traumatically, a broader cohort of approximately 1 million patients represents a largely undefined group of people with paralysis due to diseases such as spinal stenosis, cancer, infection, multiple sclerosis, or other non-traumatic causes.

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high—up to 50%—for people with spinal cord injury/disease.

As a result, the population with SCI/D is comprised primarily of young adult males who have relatively few chronic medical conditions at the time of their injury and age with SCI/D, and older patients who are more likely to have already developed chronic medical conditions by the time of their SCI/D. Approximately 60% of SCI/Ds result in tetraplegia (ie, 4 limbs affected), although approximately two-thirds are incomplete, meaning that patients have some residual motor or sensory function below the level of injury.² Not surprisingly, the level and severity of SCI/D impact life expectancy inversely and lifetime financial costs directly.

High health care utilization. Morbidity data largely parallel mortality data, often resulting in high health care utilization and cost among SCI/D patients.²⁸ In a recent prospective observational study of nearly 1000 people with new traumatic SCI, 36.2% were rehospitalized at least once and 12.5% were rehospitalized at least twice during the 12-month period after discharge following injury.²⁹

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high (36%-50%) for people with SCI/D.^29,30 The leading causes of rehospitalization—pneumonia, urinary tract infection (UTI), and pressure ulcers²⁹—have not changed over the years and persist over the lifetime of individuals with SCI/D.³⁰

Take steps to prevent pneumonia, other respiratory complications

Many people with SCI/D are at high risk for respiratory complications because of their weakened respiratory muscles. This is particularly true for individuals who have injuries occurring above T10; those with injuries that are high on the spinal cord have the highest complication risk.^7,8 In fact, pneumonia, atelectasis, and other respiratory complications are the leading causes of mortality in patients with tetraplegia, occurring in 40% to 70% of these patients.⁷

The diaphragm, innervated by the phrenic nerve (C3-C5), is the primary muscle of inspiration. Accessory muscles of inspiration include the scalenes (C5-C8), sternocleidomastoid and trapezius (C1-C4), and intercostals (T1-T11); whereas forced exhalation (cough) occurs with contraction of the abdominals (T5-T12).⁹ Diminished inspiration in individuals with higher level lesions can lead to microatelectasis, dyspnea with exertion, and even respiratory insufficiency.

In SCI/D above T8, weakened expiration can severely decrease cough effectiveness and secretion clearance, increasing susceptibility to lower respiratory tract infections. In addition, experts have described asthma-like disorders of airway function, particularly in those with higher lesions, due to unopposed parasympathetic innervation of respiratory smooth muscle.¹⁰

Use general population guidelines to target antibiotic therapy, as guidelines validated for use in the spinal cord injury/disease population don't exist.

Management of this neurogenic pulmonary dysfunction after SCI/D relies on extensive preventive measures, including positioning and postural changes, breathing techniques, coughing (assisted for patients with tetraplegia), postural drainage, chest compression and percussion, and suctioning to avoid atelectasis, aspiration, and pneumonia. Ensure that patients receive influenza and pneumococcal vaccinations, and encourage smoking cessation. Obtain a chest x-ray if the patient demonstrates a decrease in respiratory function, deteriorating vital signs, reduced vital capacity, an increase in subjective dyspnea, or a change in sputum quantity. Treat respiratory infections early and aggressively,^7-10 and strongly consider inpatient management because of the high risk of respiratory failure.

Pneumococcus is the most common cause of respiratory infections, although up to 21% of cases of community-acquired pneumonia in patients with SCI/D are caused by Pseudomonas.^11-13 Avoid the use of antibiotics in patients who do not have signs or symptoms of a respiratory infection to minimize the development of resistant organisms. Target antibiotic therapy as per general population guidelines, as guidelines validated for use in the population with SCI/D do not currently exist.^7,11

Be alert for UTIs—typical signs, symptoms don’t apply

The bladder receives innervation from S2 to S4 via the hypogastric, pudendal, and pelvic nerves. As such, the vast majority—70% to 84%—of patients with SCI/D report some degree of bladder dysfunction.¹⁴ Generally, SCI/D contributes to a combination of a failure to empty the bladder and a failure to store urine. The former is more frequent and the latter occurs more often in people with bladder outlet flaccidity, which usually occurs with low injury, such as that of the lumbar spine.¹⁴

The majority of people with SCI/D who are unable to empty their bladder require the use of some type of bladder catheter, either intermittent, indwelling (urethral or suprapubic), or condom. The choice of bladder management technique depends on gender, hand function, body habitus, caregiver assistance, and medical comorbidities. People with SCI/D are at greater risk for bladder and renal stones, UTI, vesicoureteral reflux, and bladder cancer.^15,16 That said, the risk of bladder and renal stones declines somewhat after the first 6 months following an injury due to an immobility-induced loss of calcium.

One can't rely on the typical UTI symptoms of dysuria and increased urinary frequency in this patient population.

Patients with SCI/D are often found to have bacteruria and even pyuria, and although they are at high risk for recurrent UTIs, these can be difficult to diagnose because signs and symptoms may differ from those seen in people with neurologically intact bladders. Symptomatic UTIs may present with fever, hematuria, abdominal discomfort, and/or increased spasticity, among other symptoms. They may cause increased bouts of autonomic dysreflexia, malaise, or a change in functional status. One cannot rely on the typical symptoms of dysuria and increased urinary frequency in this patient population. Further, the Infectious Diseases Society of America (IDSA) states that cloudy or foul-smelling urine in adults with catheters is not a symptom or sign mandating treatment.¹⁷

Because there is a lack of consensus as to what constitutes UTI symptoms in patients with SCI/D, PCPs need to be aware of changes from baseline in patients; these, combined with urine dip and culture results, should guide initiation of treatment.¹⁶

Prophylactic antibiotics have no role in the prevention of UTIs in patients with SCI/D. The minimal benefits associated with prophylaxis are outweighed by the risks of increased bacterial resistance to antibiotics. Research shows no significant benefit associated with the use of non-antibiotic prophylaxis, including the use of cranberry products and mannose, but further studies are needed in this patient population.¹⁸

Focus on bowel function; it correlates with quality of life

Bowel dysfunction is nearly universal in patients with SCI/D. The enteric nervous system is modulated via the sympathetic, parasympathetic, and somatic systems, and intrinsic control occurs via the myenteric and submucosal plexi. The loss of volitional control of defecation can result in prolonged transit time, reduced colonic motility, fecal incontinence, and difficulty with evacuation.

Because bowel care and function are highly correlated with quality of life,¹⁹ recommend bowel emptying every day or every other day, as well as adequate fiber in the diet, intake of fluids, stool softeners, bulk forming agents, contact irritants (eg, bisacodyl), and prokinetic agents to achieve optimal bowel care.

Prevent and treat pressure ulcers whenever possible

Fertility is often unaffected in women with spinal cord injury/disease, so routine discussions about contraception in those who are sexually active are imperative.

Accompanying the paralysis associated with SCI/D is often some degree of sensory loss of pain, light touch, temperature, and/or proprioception. The combination of insensate skin, immobility, and sarcopenia with resultant body composition changes places individuals with SCI/D at high risk for skin breakdown.^21,22 Blood flow and oxygen tension at the skin surface are also decreased in patients with SCI/D compared to those without, further contributing to the problem.^21,23 Increased latency from the time of injury correlates with increased likelihood of pressure ulcer development.^21,22,24

External risk factors for pressure ulcers include prolonged pressure exposure, or intense pressure over a short period, shear forces, poor nutrition, smoking, moisture, and immobility. The incidence of pressure ulcers in patients with SCI/D is 25% to 66%, compared with 0.38% in the general population.^21,22 Research indicates that US hospitals spend $11 billion annually on the treatment of the condition.²²

To minimize pressure ulcers in this population, perform a risk assessment, using, for example, the Spinal Cord Injury Pressure Ulcer Scale-Acute (SCIPUS-A) available at https://www.scireproject.com/outcome-measures-new/spinal-cord-injury-pressure-ulcer-scale-acute-scipus. In addition, recommend that patients use pressure redistribution surfaces for beds and wheelchairs, turn while in bed, perform frequent (approximately every 15-30 minutes) pressure reliefs, exercise or move regularly, and that they or a caregiver inspect the skin daily. If pressure ulcers do occur, start treatment immediately and document the stage of the ulcer.

Ensure that screening efforts go beyond what’s standard

Preventive care for patients with SCI/D is similar in many ways to that recommended for the general population. Screening for colorectal cancer,³¹ cervical cancer, and breast cancer³² should follow the same evidence-based intervals and age ranges suggested by groups such as the US Preventive Services Task Force (USPSTF). The only difference is to give special consideration to patients’ physical limitations and the set-up of exam rooms when scheduling and conducting procedures, such as Pap smears, colonoscopies, and mammograms.^33,34

Bladder cancer. Because of the high risk for bladder cancer (ie, squamous cell carcinoma, as opposed to the more common transitional cell carcinoma) in this population, experts recommend annual cystoscopy for bladder cancer surveillance in patients who have had indwelling catheters for more than 5 to 10 years.³⁵

Osteoporosis. Screening for osteoporosis is another preventive health area in which recommendations differ from those addressing the general population. Paralysis contributes to a decrease in mechanical stress on bone and to accelerated bone loss, and, thus, to osteoporosis.³⁶

In patients with SCI/D, osteoporosis affects primarily weight-bearing areas below the injured lesion, such as the distal femur and proximal tibia. Fractures in patients with SCI/D may occur during minor trauma (eg, during transfers from wheelchair to bed). Although screening and treatment guidelines for osteoporosis in patients with SCI/D are not established, most experts recommend early screening and early and aggressive treatment.³⁶

Male fertility is usually profoundly affected by spinal cord injury/disease; patients and their partners who are interested in having children will require specialized interventions.

Depression reportedly occurs more frequently in individuals with SCI/D than in the general population,^37,38 affecting adjustment, quality of life, and social, behavioral, and physical functioning. In light of this, it’s advisable to use screening tools, such as The Patient Health Questionnaire (PHQ)-9, routinely.³⁹

Sexuality and sexual function are often adversely affected in both men and women with SCI/D. Loss of sensation in the sexual organs, combined with difficulty with positioning and mobility and bowel and bladder dysfunction, contribute not only to sexual dysfunction, but to lower self-esteem and altered body image.⁴⁰

It is important to remember that fertility is often unaffected in women, so routine discussions about contraception with women who have SCI/D and who are sexually active are imperative. At the same time, male fertility is usually profoundly affected by SCI/D; patients and their partners who are interested in having children will require specialized interventions. Address sexuality and fertility during primary care visits and refer patients to counseling or specialists as necessary.^41-43

SCI/D requires a whole-person approach

The care of individuals with SCI/D requires a holistic approach that takes into consideration physical, psychological, environmental, and interpersonal factors^44,45 and involves ongoing support from a variety of specialists. FPs, with their whole-person orientation, can be instrumental in ensuring the successful rehabilitation of patients affected by SCI/D, and in helping individuals attain, preserve, and enhance their health and well-being.

CORRESPONDENCE
Ranit Mishori, MD, MHS, FAAFP, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Pre-clinical Building GB-01D, Washington, DC 20007; [email protected].

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

[email protected]

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

[email protected]

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

[email protected]

BALTIMORE – Research into how primary hyperparathyroidism and parathyroidectomy affect sleep quality has been limited, but investigators at the Medical College of Wisconsin, Milwaukee, reported that primary hyperparathyroidism does indeed disrupt sleep patterns and that curative surgery can improve sleep quality in a third of patients.

“Today, most patients with primary hyperparathyroidism have what is considered asymptomatic disease,” Justin La reported at the annual meeting of the American Association of Endocrine Surgeons. “However, recent studies demonstrate that many of these asymptomatic patients commonly exhibit neuropsychological problems, including sleep disturbances.” Mr. La is a fourth-year medical student at the Medical College of Wisconsin.

This prospective study, led by Dr. Tina Yen, recruited patients between June 2013 and September 2015 and compared 110 patients who had parathyroidectomy for primary hyperparathyroidism (PHPT) with 45 controls who had thyroidectomy for benign euthyroid disease between June 2013 and September 2015.

“Multiple studies, including recent meta-analyses, have demonstrated lower quality of life in patients with primary hyperparathyroidism and have suggested that patients, regardless of symptoms or degree of hypercalcemia, report varying degrees of improvement after parathyroidectomy,” Mr. La said. “In contrast there is a relative paucity of literature on the effects of primary hyperparathyroidism on sleep quality and changes after parathyroidectomy.”

He noted studies from both the University of Texas M.D. Anderson Cancer Center, Houston, and the University of Wisconsin–Madison had demonstrated a 44%-63% incidence of sleep disturbance preoperatively and improvement postoperatively in patients with PHPT who had parathyroidectomy (Endocr Pract. 2007 Jul-Aug;13:338-44; World J Surg. 2014 Mar;38:542-8; Surgery. 2009 Dec;146:1116-22).

“However, these studies were limited by small sample sizes and lack of a control group,” La said.

The latest study had subjects complete questionnaires inquiring about quality of life and sleep patterns at three different intervals: before surgery; and 1 and 6 months after surgery. The study used the Medical Outcomes Study SF-36 to assess quality of life and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. The PSQI rates sleep quality on a scale of 0 to 21; a score of 5 or higher indicates poor sleep quality.

“Compared to the preoperative scores, sleep scores after parathyroidectomy were lower, signifying better sleep quality among the 105 patients who completed 1-month postoperative surveys and the 94 patients who completed the 6-month surveys,” La said.

Before surgery, PHPT patients had worse sleep quality than their thyroid counterparts with PSQI scores of 8.1 vs. 5.3, respectively. After surgery, sleep quality scores between the two groups were similar, with mean PSQI scores of 6.3 vs. 5.3 at 1 month after surgery for the parathyroid and thyroid groups, respectively, and 5.8 vs. 4.6 for the two groups at 6 months.

Also, the proportion of patients in both groups who had poor sleep quality after surgery showed no statistical difference. At 1 month after surgery, 50% of patients in the parathyroid group and 40% in the thyroid group continued to have poor sleep quality, La said. However, when comparing preoperative with postoperative sleep scores, 37% in the parathyroid group had a noticeable improvement in their sleep scores, while only 10% of the thyroid group demonstrated improvement.

The researchers also evaluated physical and mental function in the two groups. “Preoperative overall health status was significantly worse in the parathyroid group,” La said. At 1 and 6 months after parathyroidectomy, only two physical components, physical functioning and bodily pain, remained worse in the PHPT patients. Compared with preoperative scores, PHPT patients showed statistically significant improvement in all four mental components at both postoperative periods. “In contrast, the thyroid group demonstrated no significant changes in the preoperative to postoperative scores in all eight components,” La said.

“Our study adds to the body of literature suggesting that asymptomatic patients with primary hyperparathyroidism are unlikely to be truly asymptomatic,” La said. “All patients with primary hyperparathyroidism should be referred for surgical consultation, particularly those with neurocognitive symptoms.”

He also said that patients should be counseled that improvement in sleep quality and quality of life, if they are to occur, typically are seen within 1 month after surgery.

Mr. La, Dr. Yen, and the study coauthors had no relationships to disclose.

BALTIMORE – Research into how primary hyperparathyroidism and parathyroidectomy affect sleep quality has been limited, but investigators at the Medical College of Wisconsin, Milwaukee, reported that primary hyperparathyroidism does indeed disrupt sleep patterns and that curative surgery can improve sleep quality in a third of patients.

“Today, most patients with primary hyperparathyroidism have what is considered asymptomatic disease,” Justin La reported at the annual meeting of the American Association of Endocrine Surgeons. “However, recent studies demonstrate that many of these asymptomatic patients commonly exhibit neuropsychological problems, including sleep disturbances.” Mr. La is a fourth-year medical student at the Medical College of Wisconsin.

This prospective study, led by Dr. Tina Yen, recruited patients between June 2013 and September 2015 and compared 110 patients who had parathyroidectomy for primary hyperparathyroidism (PHPT) with 45 controls who had thyroidectomy for benign euthyroid disease between June 2013 and September 2015.

“Multiple studies, including recent meta-analyses, have demonstrated lower quality of life in patients with primary hyperparathyroidism and have suggested that patients, regardless of symptoms or degree of hypercalcemia, report varying degrees of improvement after parathyroidectomy,” Mr. La said. “In contrast there is a relative paucity of literature on the effects of primary hyperparathyroidism on sleep quality and changes after parathyroidectomy.”

He noted studies from both the University of Texas M.D. Anderson Cancer Center, Houston, and the University of Wisconsin–Madison had demonstrated a 44%-63% incidence of sleep disturbance preoperatively and improvement postoperatively in patients with PHPT who had parathyroidectomy (Endocr Pract. 2007 Jul-Aug;13:338-44; World J Surg. 2014 Mar;38:542-8; Surgery. 2009 Dec;146:1116-22).

“However, these studies were limited by small sample sizes and lack of a control group,” La said.

The latest study had subjects complete questionnaires inquiring about quality of life and sleep patterns at three different intervals: before surgery; and 1 and 6 months after surgery. The study used the Medical Outcomes Study SF-36 to assess quality of life and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. The PSQI rates sleep quality on a scale of 0 to 21; a score of 5 or higher indicates poor sleep quality.

“Compared to the preoperative scores, sleep scores after parathyroidectomy were lower, signifying better sleep quality among the 105 patients who completed 1-month postoperative surveys and the 94 patients who completed the 6-month surveys,” La said.

Before surgery, PHPT patients had worse sleep quality than their thyroid counterparts with PSQI scores of 8.1 vs. 5.3, respectively. After surgery, sleep quality scores between the two groups were similar, with mean PSQI scores of 6.3 vs. 5.3 at 1 month after surgery for the parathyroid and thyroid groups, respectively, and 5.8 vs. 4.6 for the two groups at 6 months.

Also, the proportion of patients in both groups who had poor sleep quality after surgery showed no statistical difference. At 1 month after surgery, 50% of patients in the parathyroid group and 40% in the thyroid group continued to have poor sleep quality, La said. However, when comparing preoperative with postoperative sleep scores, 37% in the parathyroid group had a noticeable improvement in their sleep scores, while only 10% of the thyroid group demonstrated improvement.

The researchers also evaluated physical and mental function in the two groups. “Preoperative overall health status was significantly worse in the parathyroid group,” La said. At 1 and 6 months after parathyroidectomy, only two physical components, physical functioning and bodily pain, remained worse in the PHPT patients. Compared with preoperative scores, PHPT patients showed statistically significant improvement in all four mental components at both postoperative periods. “In contrast, the thyroid group demonstrated no significant changes in the preoperative to postoperative scores in all eight components,” La said.

“Our study adds to the body of literature suggesting that asymptomatic patients with primary hyperparathyroidism are unlikely to be truly asymptomatic,” La said. “All patients with primary hyperparathyroidism should be referred for surgical consultation, particularly those with neurocognitive symptoms.”

He also said that patients should be counseled that improvement in sleep quality and quality of life, if they are to occur, typically are seen within 1 month after surgery.

Mr. La, Dr. Yen, and the study coauthors had no relationships to disclose.

BALTIMORE – Research into how primary hyperparathyroidism and parathyroidectomy affect sleep quality has been limited, but investigators at the Medical College of Wisconsin, Milwaukee, reported that primary hyperparathyroidism does indeed disrupt sleep patterns and that curative surgery can improve sleep quality in a third of patients.

“Today, most patients with primary hyperparathyroidism have what is considered asymptomatic disease,” Justin La reported at the annual meeting of the American Association of Endocrine Surgeons. “However, recent studies demonstrate that many of these asymptomatic patients commonly exhibit neuropsychological problems, including sleep disturbances.” Mr. La is a fourth-year medical student at the Medical College of Wisconsin.

This prospective study, led by Dr. Tina Yen, recruited patients between June 2013 and September 2015 and compared 110 patients who had parathyroidectomy for primary hyperparathyroidism (PHPT) with 45 controls who had thyroidectomy for benign euthyroid disease between June 2013 and September 2015.

“Multiple studies, including recent meta-analyses, have demonstrated lower quality of life in patients with primary hyperparathyroidism and have suggested that patients, regardless of symptoms or degree of hypercalcemia, report varying degrees of improvement after parathyroidectomy,” Mr. La said. “In contrast there is a relative paucity of literature on the effects of primary hyperparathyroidism on sleep quality and changes after parathyroidectomy.”

He noted studies from both the University of Texas M.D. Anderson Cancer Center, Houston, and the University of Wisconsin–Madison had demonstrated a 44%-63% incidence of sleep disturbance preoperatively and improvement postoperatively in patients with PHPT who had parathyroidectomy (Endocr Pract. 2007 Jul-Aug;13:338-44; World J Surg. 2014 Mar;38:542-8; Surgery. 2009 Dec;146:1116-22).

“However, these studies were limited by small sample sizes and lack of a control group,” La said.

The latest study had subjects complete questionnaires inquiring about quality of life and sleep patterns at three different intervals: before surgery; and 1 and 6 months after surgery. The study used the Medical Outcomes Study SF-36 to assess quality of life and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. The PSQI rates sleep quality on a scale of 0 to 21; a score of 5 or higher indicates poor sleep quality.

“Compared to the preoperative scores, sleep scores after parathyroidectomy were lower, signifying better sleep quality among the 105 patients who completed 1-month postoperative surveys and the 94 patients who completed the 6-month surveys,” La said.

Before surgery, PHPT patients had worse sleep quality than their thyroid counterparts with PSQI scores of 8.1 vs. 5.3, respectively. After surgery, sleep quality scores between the two groups were similar, with mean PSQI scores of 6.3 vs. 5.3 at 1 month after surgery for the parathyroid and thyroid groups, respectively, and 5.8 vs. 4.6 for the two groups at 6 months.

Also, the proportion of patients in both groups who had poor sleep quality after surgery showed no statistical difference. At 1 month after surgery, 50% of patients in the parathyroid group and 40% in the thyroid group continued to have poor sleep quality, La said. However, when comparing preoperative with postoperative sleep scores, 37% in the parathyroid group had a noticeable improvement in their sleep scores, while only 10% of the thyroid group demonstrated improvement.

The researchers also evaluated physical and mental function in the two groups. “Preoperative overall health status was significantly worse in the parathyroid group,” La said. At 1 and 6 months after parathyroidectomy, only two physical components, physical functioning and bodily pain, remained worse in the PHPT patients. Compared with preoperative scores, PHPT patients showed statistically significant improvement in all four mental components at both postoperative periods. “In contrast, the thyroid group demonstrated no significant changes in the preoperative to postoperative scores in all eight components,” La said.

“Our study adds to the body of literature suggesting that asymptomatic patients with primary hyperparathyroidism are unlikely to be truly asymptomatic,” La said. “All patients with primary hyperparathyroidism should be referred for surgical consultation, particularly those with neurocognitive symptoms.”

He also said that patients should be counseled that improvement in sleep quality and quality of life, if they are to occur, typically are seen within 1 month after surgery.

Mr. La, Dr. Yen, and the study coauthors had no relationships to disclose.

I believe there is no better field than hospital medicine to find your career path, and there’s no better organization than SHM to support you as you follow that path. My path is probably similar to most, a little unplanned and a little unexpected, but I am sure each member has their story. Hospital medicine made an early impact on me during an internship where I was exposed to physician role models with terrific leadership skills. They were blazing trails by challenging long-held beliefs about the care of hospitalized patients.

The term “hospitalist” had not yet quite penetrated national consciousness, but Dr. Bob Wachter and Dr. Lee Goldman had already started implementing the model at the University of California, San Francisco, where I was privileged to be an intern during an exciting time. There, I learned directly from some of the individuals who would quickly become pioneers in hospital medicine, influencing a generation of physicians by putting definition and structure around the concept of a hospitalist.

During residency, I saw these hospitalists demonstrate key leadership attributes that distinguished from other physicians. They had an appreciation for the team, a collaborative approach, and an ability to understand the complexity of coordinating acute care. They led from the front, not from behind the lines. So it was no wonder that so many of my colleagues gravitated toward this new field.

After residency, my first job was at a community hospital in Marin, Calif., where a new hospitalist program had started just a year or two earlier. The same collaborative skills that created better patient care with nurses, pharmacists, and the medical staff were positively reinforced and recognized. I got married and had my first child, and my path took a turn east to the Cleveland Clinic. Now back in the academic world and after two more children, that path for me turned in highly unexpected ways—as a department chair, then as medical director for data and analytics, then briefly overseeing population health, and now as head of a hospital in the Cleveland Clinic system.

Stories like mine are not at all extraordinary. At HM16 in San Diego, I heard stories of hospitalists ascendant in their organizations, being given incredible responsibilities and a long rope. The day-to-day work we have done as hospitalists has been our training for all these roles. This daily practice demands a level of growth, development, and exposure that no other specialty requires. There is no better environment to learn about leadership, teaching, and complex systems than perhaps the most complex system of all—the hospital. In this environment, we have innumerable opportunities to find, pick, and create our own paths to improve our healthcare system at every level from the bedside to the top of the Centers for Medicare & Medicaid Services (CMS).

Hospital medicine puts so many components and challenges of healthcare in our daily practice: complex team problem-solving; relationships up, down, and across a hierarchy; IT; education; process improvement; ethics; medical staff politics. The successful hospitalist, by definition, has to be able to learn and attain mastery across a broad set of knowledge and skills. We have become naturals in a world of "matrixes management" because it is how we live our lives every day. This is why when our medical staffs and administration come looking for a project leader, a new department chair, a head of patient experience, a leader, or an educator, they come looking for us.

As SHM’s new president, I commit to SHM being the organization that is dedicated to helping you. It’s impossible to see around every corner, but starting in the coming year, I think SHM and hospitalists have to move forward in four key directions:

1. Expand and engage SHM’s membership. Although we just reached our 15,000th member, there are 52,000 hospitalists, plus even more when you include advanced practice colleagues, whom we would like to become SHM members under our “big tent.” We want to draw in those hospitalists, show them how, whether it’s through our educational offerings, learning portal, or active involvement in projects and committees, we can engage them at every stage of their career—and ask them what else we can do to help them find their path and be prepared for it.
2. We must continue pushing our members and projects to be focused on patient- and family-centered care. Every project that takes the extra steps of incorporating the thoughts and feelings of our patients and families will get a better result. I would like to see hospitalists everywhere take a strong position to remember that our patients and their families are our partners in their care; We need to lead on the patient experience and patient-centered care front. Two years ago, we launched the Patient Experience Committee to do just that, and it is an important research topic on the minds of the Journal of Hospital Medicine editors. After all, we are all people needing people.
3. We have to move assertively to understand our role in an era of risk. While in many senses we have been managing risk either directly or indirectly for decades, the payment models of care (episodes, bundles, MIPS, ACOs) are evolving quickly, and we must stake out our place in this new risk-sharing world and identify our partners. Hospitalists need to have a clear message about how what we do mitigates risk and adds value. In the coming year, SHM will start to do that.
4. In the coming years, we will need to clarify our position regarding specialty recognition, including our training programs. We already have many key components that we identify with as a specialty. While this is also something contentious and political, when we look at the divergence between what we have to do to be clinically effective (e.g., palliative medicine, ICU care, QI, leadership, etc.) and what our training programs provide for us, that gap appears to be increasing. SHM has stepped up with curriculum to fill these gaps and will continue to do so. However, we must question how best to train physicians for these roles and if the current model is sustainable and suitable.

I am privileged and honored to serve as your new president, and I ask each of you to look at yourselves and the opportunities that your practice provides you with to grow—personally and professionally—and make our system and specialty better. Look to SHM to help you, support you, and provide resources for you to walk your path. TH

Dr. Harte is a practicing hospitalist, president of the Society of Hospital Medicine, and president of Hillcrest Hospital in Mayfield Heights, Ohio, part of the Cleveland Clinic Health System. He is associate professor of medicine at the Lerner College of Medicine in Cleveland.

I believe there is no better field than hospital medicine to find your career path, and there’s no better organization than SHM to support you as you follow that path. My path is probably similar to most, a little unplanned and a little unexpected, but I am sure each member has their story. Hospital medicine made an early impact on me during an internship where I was exposed to physician role models with terrific leadership skills. They were blazing trails by challenging long-held beliefs about the care of hospitalized patients.

The term “hospitalist” had not yet quite penetrated national consciousness, but Dr. Bob Wachter and Dr. Lee Goldman had already started implementing the model at the University of California, San Francisco, where I was privileged to be an intern during an exciting time. There, I learned directly from some of the individuals who would quickly become pioneers in hospital medicine, influencing a generation of physicians by putting definition and structure around the concept of a hospitalist.

During residency, I saw these hospitalists demonstrate key leadership attributes that distinguished from other physicians. They had an appreciation for the team, a collaborative approach, and an ability to understand the complexity of coordinating acute care. They led from the front, not from behind the lines. So it was no wonder that so many of my colleagues gravitated toward this new field.

After residency, my first job was at a community hospital in Marin, Calif., where a new hospitalist program had started just a year or two earlier. The same collaborative skills that created better patient care with nurses, pharmacists, and the medical staff were positively reinforced and recognized. I got married and had my first child, and my path took a turn east to the Cleveland Clinic. Now back in the academic world and after two more children, that path for me turned in highly unexpected ways—as a department chair, then as medical director for data and analytics, then briefly overseeing population health, and now as head of a hospital in the Cleveland Clinic system.

Stories like mine are not at all extraordinary. At HM16 in San Diego, I heard stories of hospitalists ascendant in their organizations, being given incredible responsibilities and a long rope. The day-to-day work we have done as hospitalists has been our training for all these roles. This daily practice demands a level of growth, development, and exposure that no other specialty requires. There is no better environment to learn about leadership, teaching, and complex systems than perhaps the most complex system of all—the hospital. In this environment, we have innumerable opportunities to find, pick, and create our own paths to improve our healthcare system at every level from the bedside to the top of the Centers for Medicare & Medicaid Services (CMS).

Hospital medicine puts so many components and challenges of healthcare in our daily practice: complex team problem-solving; relationships up, down, and across a hierarchy; IT; education; process improvement; ethics; medical staff politics. The successful hospitalist, by definition, has to be able to learn and attain mastery across a broad set of knowledge and skills. We have become naturals in a world of "matrixes management" because it is how we live our lives every day. This is why when our medical staffs and administration come looking for a project leader, a new department chair, a head of patient experience, a leader, or an educator, they come looking for us.

As SHM’s new president, I commit to SHM being the organization that is dedicated to helping you. It’s impossible to see around every corner, but starting in the coming year, I think SHM and hospitalists have to move forward in four key directions:

1. Expand and engage SHM’s membership. Although we just reached our 15,000th member, there are 52,000 hospitalists, plus even more when you include advanced practice colleagues, whom we would like to become SHM members under our “big tent.” We want to draw in those hospitalists, show them how, whether it’s through our educational offerings, learning portal, or active involvement in projects and committees, we can engage them at every stage of their career—and ask them what else we can do to help them find their path and be prepared for it.
2. We must continue pushing our members and projects to be focused on patient- and family-centered care. Every project that takes the extra steps of incorporating the thoughts and feelings of our patients and families will get a better result. I would like to see hospitalists everywhere take a strong position to remember that our patients and their families are our partners in their care; We need to lead on the patient experience and patient-centered care front. Two years ago, we launched the Patient Experience Committee to do just that, and it is an important research topic on the minds of the Journal of Hospital Medicine editors. After all, we are all people needing people.
3. We have to move assertively to understand our role in an era of risk. While in many senses we have been managing risk either directly or indirectly for decades, the payment models of care (episodes, bundles, MIPS, ACOs) are evolving quickly, and we must stake out our place in this new risk-sharing world and identify our partners. Hospitalists need to have a clear message about how what we do mitigates risk and adds value. In the coming year, SHM will start to do that.
4. In the coming years, we will need to clarify our position regarding specialty recognition, including our training programs. We already have many key components that we identify with as a specialty. While this is also something contentious and political, when we look at the divergence between what we have to do to be clinically effective (e.g., palliative medicine, ICU care, QI, leadership, etc.) and what our training programs provide for us, that gap appears to be increasing. SHM has stepped up with curriculum to fill these gaps and will continue to do so. However, we must question how best to train physicians for these roles and if the current model is sustainable and suitable.

I am privileged and honored to serve as your new president, and I ask each of you to look at yourselves and the opportunities that your practice provides you with to grow—personally and professionally—and make our system and specialty better. Look to SHM to help you, support you, and provide resources for you to walk your path. TH

Dr. Harte is a practicing hospitalist, president of the Society of Hospital Medicine, and president of Hillcrest Hospital in Mayfield Heights, Ohio, part of the Cleveland Clinic Health System. He is associate professor of medicine at the Lerner College of Medicine in Cleveland.

I believe there is no better field than hospital medicine to find your career path, and there’s no better organization than SHM to support you as you follow that path. My path is probably similar to most, a little unplanned and a little unexpected, but I am sure each member has their story. Hospital medicine made an early impact on me during an internship where I was exposed to physician role models with terrific leadership skills. They were blazing trails by challenging long-held beliefs about the care of hospitalized patients.

The term “hospitalist” had not yet quite penetrated national consciousness, but Dr. Bob Wachter and Dr. Lee Goldman had already started implementing the model at the University of California, San Francisco, where I was privileged to be an intern during an exciting time. There, I learned directly from some of the individuals who would quickly become pioneers in hospital medicine, influencing a generation of physicians by putting definition and structure around the concept of a hospitalist.

During residency, I saw these hospitalists demonstrate key leadership attributes that distinguished from other physicians. They had an appreciation for the team, a collaborative approach, and an ability to understand the complexity of coordinating acute care. They led from the front, not from behind the lines. So it was no wonder that so many of my colleagues gravitated toward this new field.

After residency, my first job was at a community hospital in Marin, Calif., where a new hospitalist program had started just a year or two earlier. The same collaborative skills that created better patient care with nurses, pharmacists, and the medical staff were positively reinforced and recognized. I got married and had my first child, and my path took a turn east to the Cleveland Clinic. Now back in the academic world and after two more children, that path for me turned in highly unexpected ways—as a department chair, then as medical director for data and analytics, then briefly overseeing population health, and now as head of a hospital in the Cleveland Clinic system.

Stories like mine are not at all extraordinary. At HM16 in San Diego, I heard stories of hospitalists ascendant in their organizations, being given incredible responsibilities and a long rope. The day-to-day work we have done as hospitalists has been our training for all these roles. This daily practice demands a level of growth, development, and exposure that no other specialty requires. There is no better environment to learn about leadership, teaching, and complex systems than perhaps the most complex system of all—the hospital. In this environment, we have innumerable opportunities to find, pick, and create our own paths to improve our healthcare system at every level from the bedside to the top of the Centers for Medicare & Medicaid Services (CMS).

Hospital medicine puts so many components and challenges of healthcare in our daily practice: complex team problem-solving; relationships up, down, and across a hierarchy; IT; education; process improvement; ethics; medical staff politics. The successful hospitalist, by definition, has to be able to learn and attain mastery across a broad set of knowledge and skills. We have become naturals in a world of "matrixes management" because it is how we live our lives every day. This is why when our medical staffs and administration come looking for a project leader, a new department chair, a head of patient experience, a leader, or an educator, they come looking for us.

As SHM’s new president, I commit to SHM being the organization that is dedicated to helping you. It’s impossible to see around every corner, but starting in the coming year, I think SHM and hospitalists have to move forward in four key directions:

1. Expand and engage SHM’s membership. Although we just reached our 15,000th member, there are 52,000 hospitalists, plus even more when you include advanced practice colleagues, whom we would like to become SHM members under our “big tent.” We want to draw in those hospitalists, show them how, whether it’s through our educational offerings, learning portal, or active involvement in projects and committees, we can engage them at every stage of their career—and ask them what else we can do to help them find their path and be prepared for it.
2. We must continue pushing our members and projects to be focused on patient- and family-centered care. Every project that takes the extra steps of incorporating the thoughts and feelings of our patients and families will get a better result. I would like to see hospitalists everywhere take a strong position to remember that our patients and their families are our partners in their care; We need to lead on the patient experience and patient-centered care front. Two years ago, we launched the Patient Experience Committee to do just that, and it is an important research topic on the minds of the Journal of Hospital Medicine editors. After all, we are all people needing people.
3. We have to move assertively to understand our role in an era of risk. While in many senses we have been managing risk either directly or indirectly for decades, the payment models of care (episodes, bundles, MIPS, ACOs) are evolving quickly, and we must stake out our place in this new risk-sharing world and identify our partners. Hospitalists need to have a clear message about how what we do mitigates risk and adds value. In the coming year, SHM will start to do that.
4. In the coming years, we will need to clarify our position regarding specialty recognition, including our training programs. We already have many key components that we identify with as a specialty. While this is also something contentious and political, when we look at the divergence between what we have to do to be clinically effective (e.g., palliative medicine, ICU care, QI, leadership, etc.) and what our training programs provide for us, that gap appears to be increasing. SHM has stepped up with curriculum to fill these gaps and will continue to do so. However, we must question how best to train physicians for these roles and if the current model is sustainable and suitable.

I am privileged and honored to serve as your new president, and I ask each of you to look at yourselves and the opportunities that your practice provides you with to grow—personally and professionally—and make our system and specialty better. Look to SHM to help you, support you, and provide resources for you to walk your path. TH

Dr. Harte is a practicing hospitalist, president of the Society of Hospital Medicine, and president of Hillcrest Hospital in Mayfield Heights, Ohio, part of the Cleveland Clinic Health System. He is associate professor of medicine at the Lerner College of Medicine in Cleveland.

Researcher in the lab

Photo by Daniel Sone

The National Institutes of Health (NIH) has suspended production in 2 of its facilities—a National Cancer Institute (NCI) laboratory engaged in the production of cell therapies and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.

Last year, an inspection by the US Food and Drug Administration revealed problems with facilities, equipment, procedures, and training in the NIH Clinical Center Pharmaceutical Development Section (PDS), which is responsible for managing investigational drugs.

So the NIH closed the sterile production unit of the PDS and hired 2 companies specializing in quality assurance for manufacturing and compounding—Working Buildings and Clinical IQ—to evaluate all NIH facilities producing sterile or infused products for administration to research participants.

This review is still underway, and preliminary findings have identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products.

As a result, the NIH suspended production in the aforementioned facilities manufacturing cell therapy and PET materials.

The NIH said there is no evidence that any patients have been harmed, but a rigorous clinical review will be conducted. And the NIH will not enroll new patients in affected trials until the issues are resolved.

The NCI facility produces cell therapies in cooperation with Kite Pharma, Inc. The company and the NCI are advancing multiple clinical trials under Cooperative Research and Development Agreements for the treatment of hematologic malignancies and solid tumors.

Patients currently enrolled in ongoing NCI trials of cell therapy will continue to receive treatment, but no new patients will be enrolled until the review is complete.

And Kite Pharma said its 4 trials of the chimeric antigen receptor T-cell therapy KTE-C19 will continue. This includes:

ZUMA-1—KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma

ZUMA-2—KTE-C19 in patients with relapsed/refractory mantle cell lymphoma

ZUMA-3—KTE-C19 in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia

ZUMA-4—KTE-C19 in pediatric and adolescent patients with relapsed/refractory B-precursor acute lymphoblastic leukemia.

The company stressed that the review of the NCI’s manufacturing facilities is not related to KTE-C19 or Kite’s manufacturing capabilities.

Researcher in the lab

Photo by Daniel Sone

The National Institutes of Health (NIH) has suspended production in 2 of its facilities—a National Cancer Institute (NCI) laboratory engaged in the production of cell therapies and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.

Last year, an inspection by the US Food and Drug Administration revealed problems with facilities, equipment, procedures, and training in the NIH Clinical Center Pharmaceutical Development Section (PDS), which is responsible for managing investigational drugs.

So the NIH closed the sterile production unit of the PDS and hired 2 companies specializing in quality assurance for manufacturing and compounding—Working Buildings and Clinical IQ—to evaluate all NIH facilities producing sterile or infused products for administration to research participants.

This review is still underway, and preliminary findings have identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products.

As a result, the NIH suspended production in the aforementioned facilities manufacturing cell therapy and PET materials.

The NIH said there is no evidence that any patients have been harmed, but a rigorous clinical review will be conducted. And the NIH will not enroll new patients in affected trials until the issues are resolved.

The NCI facility produces cell therapies in cooperation with Kite Pharma, Inc. The company and the NCI are advancing multiple clinical trials under Cooperative Research and Development Agreements for the treatment of hematologic malignancies and solid tumors.

Patients currently enrolled in ongoing NCI trials of cell therapy will continue to receive treatment, but no new patients will be enrolled until the review is complete.

And Kite Pharma said its 4 trials of the chimeric antigen receptor T-cell therapy KTE-C19 will continue. This includes:

ZUMA-1—KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma

ZUMA-2—KTE-C19 in patients with relapsed/refractory mantle cell lymphoma

ZUMA-3—KTE-C19 in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia

ZUMA-4—KTE-C19 in pediatric and adolescent patients with relapsed/refractory B-precursor acute lymphoblastic leukemia.

The company stressed that the review of the NCI’s manufacturing facilities is not related to KTE-C19 or Kite’s manufacturing capabilities.

Researcher in the lab

Photo by Daniel Sone

The National Institutes of Health (NIH) has suspended production in 2 of its facilities—a National Cancer Institute (NCI) laboratory engaged in the production of cell therapies and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.

Last year, an inspection by the US Food and Drug Administration revealed problems with facilities, equipment, procedures, and training in the NIH Clinical Center Pharmaceutical Development Section (PDS), which is responsible for managing investigational drugs.

So the NIH closed the sterile production unit of the PDS and hired 2 companies specializing in quality assurance for manufacturing and compounding—Working Buildings and Clinical IQ—to evaluate all NIH facilities producing sterile or infused products for administration to research participants.

This review is still underway, and preliminary findings have identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products.

As a result, the NIH suspended production in the aforementioned facilities manufacturing cell therapy and PET materials.

The NIH said there is no evidence that any patients have been harmed, but a rigorous clinical review will be conducted. And the NIH will not enroll new patients in affected trials until the issues are resolved.

The NCI facility produces cell therapies in cooperation with Kite Pharma, Inc. The company and the NCI are advancing multiple clinical trials under Cooperative Research and Development Agreements for the treatment of hematologic malignancies and solid tumors.

Patients currently enrolled in ongoing NCI trials of cell therapy will continue to receive treatment, but no new patients will be enrolled until the review is complete.

And Kite Pharma said its 4 trials of the chimeric antigen receptor T-cell therapy KTE-C19 will continue. This includes:

ZUMA-1—KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma

ZUMA-2—KTE-C19 in patients with relapsed/refractory mantle cell lymphoma

ZUMA-3—KTE-C19 in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia

ZUMA-4—KTE-C19 in pediatric and adolescent patients with relapsed/refractory B-precursor acute lymphoblastic leukemia.

The company stressed that the review of the NCI’s manufacturing facilities is not related to KTE-C19 or Kite’s manufacturing capabilities.

BALTIMORE – Hemithyroidectomy for low-risk micropapillary thyroid cancer can have advantages over active surveillance, according to findings from a study that examined outcomes by cost and quality of life data.

Endocrinologists and surgeons need to have in-depth conversations with their patients to determine their level of anxiety about cancer, surgery, and about their quality of life, to determine the best course of treatment, researchers at the University of California, San Francisco (UCSF) reported at the annual meeting of the American Association of Endocrine Surgeons.

“Our study found that hemithyroidectomy is cost effective in the majority of scenarios,” presenter Shriya Venkatesh said. “However, patient perception of micropapillary thyroid cancer as well as [the patient’s] life expectancy can play a major role in deciding which therapeutic option to choose.”

The study involved a cost-effectiveness analysis of the surgery vs. active surveillance, “which is especially relevant in our current times,” Ms. Venkatesh said in an interview. “What we wanted to do is give physicians information for when they approach their patients, not only in assessing the tumor from the medical aspect but also when looking at it from quality-of-life and cost-benefit perspectives.”

Both courses of management were modeled over a 20-year period with Medicare data and literature review to calculate costs and health utilities. The UCSF researchers used Markov statistical models for both approaches in which the reference case was a 40-year-old, otherwise healthy patient with a recent diagnosis of micropapillary thyroid cancer without high-risk factors. Either hemithyroidectomy or surveillance would be reasonable treatment options.

“We found that hemithyroidectomy was about $8,000 more costly than active surveillance, but it also afforded an increase in about 1.09 quality-adjusted life years,” Ms. Venkatesh said. Hemithyroidectomy is most cost effective for patients with a life expectancy of 3 years or more and who perceive that living with low-grade thyroid cancer would have even a modest detriment on their quality of life, she said.

“Unfortunately there is no current published quality-of-life assessment of active surveillance for thyroid cancer,” Ms. Venkatesh said. “We believe that estimating active surveillance to the equivalent of surgery underestimates the anxiety some patients may feel upon receiving their diagnosis.”

The paucity of literature on active surveillance for thyroid cancer prompted the UCSF researchers to turn to the prostate cancer literature, which has more data on active surveillance, to try to determine the disutility of active surveillance for micropapillary thyroid cancer. “Our extrapolation from the literature yields a mean disutility of 0.11,” she said.

However, the utility estimates the researchers came up with were variable, Ms. Venkatesh said. “This really pushes physicians to have that conversation with their patients, not only about the physical aspects of how they’re doing but also the mental aspects,” she said.

But quality of life is difficult to quantify, senior author Dr. Insoo Suh said in an interview. “What we found is that no matter how one measures quality of life, the qualitative degree of quality of life decrease that people associate with ‘living with cancer’ need not be that significant in order for surgery to be a potentially cost-effective treatment for them,” said Dr. Suh, an endocrine surgeon at UCSF and an ACS Fellow.

During the discussion, Dr. Peter Angelos of the University of Chicago and an ACS Fellow, said, “I’m curious how this information should impact the individual decision-making and informed consent for a specific patient, because I’m not sure that an individual patient would care if active surveillance is more cost effective or not.”

“When speaking to your patients, obviously discussing the rates of progression of the disease is important and then [so is] talking to them about different therapeutic options,” Ms. Venkatesh said. “The physician should also make an assessment about the patient’s quality of life to see if there are likely to be any changes due to the diagnosis.”

The limitations of the study include the extrapolation of data from the prostate cancer literature to define a utility scale and also the reference case used in the Markov model. Other utility measures showed variability as well.

Ms. Venkatesh, Dr. Suh and their coauthors had no financial relationships to disclose.

BALTIMORE – Hemithyroidectomy for low-risk micropapillary thyroid cancer can have advantages over active surveillance, according to findings from a study that examined outcomes by cost and quality of life data.

Endocrinologists and surgeons need to have in-depth conversations with their patients to determine their level of anxiety about cancer, surgery, and about their quality of life, to determine the best course of treatment, researchers at the University of California, San Francisco (UCSF) reported at the annual meeting of the American Association of Endocrine Surgeons.

“Our study found that hemithyroidectomy is cost effective in the majority of scenarios,” presenter Shriya Venkatesh said. “However, patient perception of micropapillary thyroid cancer as well as [the patient’s] life expectancy can play a major role in deciding which therapeutic option to choose.”

The study involved a cost-effectiveness analysis of the surgery vs. active surveillance, “which is especially relevant in our current times,” Ms. Venkatesh said in an interview. “What we wanted to do is give physicians information for when they approach their patients, not only in assessing the tumor from the medical aspect but also when looking at it from quality-of-life and cost-benefit perspectives.”

Both courses of management were modeled over a 20-year period with Medicare data and literature review to calculate costs and health utilities. The UCSF researchers used Markov statistical models for both approaches in which the reference case was a 40-year-old, otherwise healthy patient with a recent diagnosis of micropapillary thyroid cancer without high-risk factors. Either hemithyroidectomy or surveillance would be reasonable treatment options.

“We found that hemithyroidectomy was about $8,000 more costly than active surveillance, but it also afforded an increase in about 1.09 quality-adjusted life years,” Ms. Venkatesh said. Hemithyroidectomy is most cost effective for patients with a life expectancy of 3 years or more and who perceive that living with low-grade thyroid cancer would have even a modest detriment on their quality of life, she said.

“Unfortunately there is no current published quality-of-life assessment of active surveillance for thyroid cancer,” Ms. Venkatesh said. “We believe that estimating active surveillance to the equivalent of surgery underestimates the anxiety some patients may feel upon receiving their diagnosis.”

The paucity of literature on active surveillance for thyroid cancer prompted the UCSF researchers to turn to the prostate cancer literature, which has more data on active surveillance, to try to determine the disutility of active surveillance for micropapillary thyroid cancer. “Our extrapolation from the literature yields a mean disutility of 0.11,” she said.

However, the utility estimates the researchers came up with were variable, Ms. Venkatesh said. “This really pushes physicians to have that conversation with their patients, not only about the physical aspects of how they’re doing but also the mental aspects,” she said.

But quality of life is difficult to quantify, senior author Dr. Insoo Suh said in an interview. “What we found is that no matter how one measures quality of life, the qualitative degree of quality of life decrease that people associate with ‘living with cancer’ need not be that significant in order for surgery to be a potentially cost-effective treatment for them,” said Dr. Suh, an endocrine surgeon at UCSF and an ACS Fellow.

During the discussion, Dr. Peter Angelos of the University of Chicago and an ACS Fellow, said, “I’m curious how this information should impact the individual decision-making and informed consent for a specific patient, because I’m not sure that an individual patient would care if active surveillance is more cost effective or not.”

“When speaking to your patients, obviously discussing the rates of progression of the disease is important and then [so is] talking to them about different therapeutic options,” Ms. Venkatesh said. “The physician should also make an assessment about the patient’s quality of life to see if there are likely to be any changes due to the diagnosis.”

The limitations of the study include the extrapolation of data from the prostate cancer literature to define a utility scale and also the reference case used in the Markov model. Other utility measures showed variability as well.

Ms. Venkatesh, Dr. Suh and their coauthors had no financial relationships to disclose.

BALTIMORE – Hemithyroidectomy for low-risk micropapillary thyroid cancer can have advantages over active surveillance, according to findings from a study that examined outcomes by cost and quality of life data.

Endocrinologists and surgeons need to have in-depth conversations with their patients to determine their level of anxiety about cancer, surgery, and about their quality of life, to determine the best course of treatment, researchers at the University of California, San Francisco (UCSF) reported at the annual meeting of the American Association of Endocrine Surgeons.

“Our study found that hemithyroidectomy is cost effective in the majority of scenarios,” presenter Shriya Venkatesh said. “However, patient perception of micropapillary thyroid cancer as well as [the patient’s] life expectancy can play a major role in deciding which therapeutic option to choose.”

The study involved a cost-effectiveness analysis of the surgery vs. active surveillance, “which is especially relevant in our current times,” Ms. Venkatesh said in an interview. “What we wanted to do is give physicians information for when they approach their patients, not only in assessing the tumor from the medical aspect but also when looking at it from quality-of-life and cost-benefit perspectives.”

Both courses of management were modeled over a 20-year period with Medicare data and literature review to calculate costs and health utilities. The UCSF researchers used Markov statistical models for both approaches in which the reference case was a 40-year-old, otherwise healthy patient with a recent diagnosis of micropapillary thyroid cancer without high-risk factors. Either hemithyroidectomy or surveillance would be reasonable treatment options.

“We found that hemithyroidectomy was about $8,000 more costly than active surveillance, but it also afforded an increase in about 1.09 quality-adjusted life years,” Ms. Venkatesh said. Hemithyroidectomy is most cost effective for patients with a life expectancy of 3 years or more and who perceive that living with low-grade thyroid cancer would have even a modest detriment on their quality of life, she said.

“Unfortunately there is no current published quality-of-life assessment of active surveillance for thyroid cancer,” Ms. Venkatesh said. “We believe that estimating active surveillance to the equivalent of surgery underestimates the anxiety some patients may feel upon receiving their diagnosis.”

The paucity of literature on active surveillance for thyroid cancer prompted the UCSF researchers to turn to the prostate cancer literature, which has more data on active surveillance, to try to determine the disutility of active surveillance for micropapillary thyroid cancer. “Our extrapolation from the literature yields a mean disutility of 0.11,” she said.

However, the utility estimates the researchers came up with were variable, Ms. Venkatesh said. “This really pushes physicians to have that conversation with their patients, not only about the physical aspects of how they’re doing but also the mental aspects,” she said.

But quality of life is difficult to quantify, senior author Dr. Insoo Suh said in an interview. “What we found is that no matter how one measures quality of life, the qualitative degree of quality of life decrease that people associate with ‘living with cancer’ need not be that significant in order for surgery to be a potentially cost-effective treatment for them,” said Dr. Suh, an endocrine surgeon at UCSF and an ACS Fellow.

During the discussion, Dr. Peter Angelos of the University of Chicago and an ACS Fellow, said, “I’m curious how this information should impact the individual decision-making and informed consent for a specific patient, because I’m not sure that an individual patient would care if active surveillance is more cost effective or not.”

“When speaking to your patients, obviously discussing the rates of progression of the disease is important and then [so is] talking to them about different therapeutic options,” Ms. Venkatesh said. “The physician should also make an assessment about the patient’s quality of life to see if there are likely to be any changes due to the diagnosis.”

The limitations of the study include the extrapolation of data from the prostate cancer literature to define a utility scale and also the reference case used in the Markov model. Other utility measures showed variability as well.

Ms. Venkatesh, Dr. Suh and their coauthors had no financial relationships to disclose.

BALTIMORE – Patients who have had parathyroidectomy for primary hyperparathyroidism can have disease recurrence 10 years or longer after surgery, raising the possibility that postop follow-up should never end, according to a study presented at the annual meeting of the American Association of Endocrine Surgeons.

Dr. Irene Lou of the University of Wisconsin–Madison reported on results of a retrospective study of 196 patients who had a presumably “curative” parathyroidectomy at the institution between November 2000 and June 2005. The mean age of the study population was 61 years.

“The long-term recurrences of primary hyperparathyroidism after curative parathyroidectomy is likely higher than previously reported, with over a third of recurrences occurring 10 years after their operation,” Dr. Lou said.

The study also identified independent predictors of recurrence, among them younger age, a drop in intraoperative parathyroid hormone less than 70%, and double adenoma, Dr. Lou said. All patients after parathyroidectomy should have at minimum an annual serum calcium test, especially younger patients with longer life expectancies, she said. This recommendation, however, may be altered for older patients or those with additional comorbidities.

The study defined recurrence as serum calcium of 10.2 mg/dL or greater 6 months or longer after the initial operation. The overall 10-year recurrence rate was 14.8% and the median time to recurrence was 6.3 years. “We found that 41.4% of patients who recurred did so by 5 years and 65.5% by 10 years,” Dr. Lou said.

The University of Wisconsin and University of Alabama at Birmingham investigators undertook the study because the recent data on recurrence was limited, with the longest study topping out at 7 years, Dr. Lou said. “We previously looked at this problem in other perspectives and we found that a lot of curves separated at around 8 years,” she said.

With regard to the type of operation the patients had, whether unilateral minimally invasive parathyroidectomy or bilateral open surgery, the study found no significant differences in recurrence rates, Dr. Lou said. “This is an excellent study,” Dr. Samuel K. Snyder of Temple, Tex., said during the discussion. “You’re telling us we need to follow patients much longer than perhaps we did previously, but we all see patients who have normal calcium and still have a residual elevated parathyroid hormone level.” He asked if the study considered parathyroid hormone levels at 6 months or more after surgery or vitamin D levels, but Dr. Lou said this information was not available, therefore could not be evaluated.

Dr. Lou and her coauthors had no financial relationships to disclose.

BALTIMORE – Patients who have had parathyroidectomy for primary hyperparathyroidism can have disease recurrence 10 years or longer after surgery, raising the possibility that postop follow-up should never end, according to a study presented at the annual meeting of the American Association of Endocrine Surgeons.

Dr. Irene Lou of the University of Wisconsin–Madison reported on results of a retrospective study of 196 patients who had a presumably “curative” parathyroidectomy at the institution between November 2000 and June 2005. The mean age of the study population was 61 years.

“The long-term recurrences of primary hyperparathyroidism after curative parathyroidectomy is likely higher than previously reported, with over a third of recurrences occurring 10 years after their operation,” Dr. Lou said.

The study also identified independent predictors of recurrence, among them younger age, a drop in intraoperative parathyroid hormone less than 70%, and double adenoma, Dr. Lou said. All patients after parathyroidectomy should have at minimum an annual serum calcium test, especially younger patients with longer life expectancies, she said. This recommendation, however, may be altered for older patients or those with additional comorbidities.

The study defined recurrence as serum calcium of 10.2 mg/dL or greater 6 months or longer after the initial operation. The overall 10-year recurrence rate was 14.8% and the median time to recurrence was 6.3 years. “We found that 41.4% of patients who recurred did so by 5 years and 65.5% by 10 years,” Dr. Lou said.

The University of Wisconsin and University of Alabama at Birmingham investigators undertook the study because the recent data on recurrence was limited, with the longest study topping out at 7 years, Dr. Lou said. “We previously looked at this problem in other perspectives and we found that a lot of curves separated at around 8 years,” she said.

With regard to the type of operation the patients had, whether unilateral minimally invasive parathyroidectomy or bilateral open surgery, the study found no significant differences in recurrence rates, Dr. Lou said. “This is an excellent study,” Dr. Samuel K. Snyder of Temple, Tex., said during the discussion. “You’re telling us we need to follow patients much longer than perhaps we did previously, but we all see patients who have normal calcium and still have a residual elevated parathyroid hormone level.” He asked if the study considered parathyroid hormone levels at 6 months or more after surgery or vitamin D levels, but Dr. Lou said this information was not available, therefore could not be evaluated.

Dr. Lou and her coauthors had no financial relationships to disclose.

BALTIMORE – Patients who have had parathyroidectomy for primary hyperparathyroidism can have disease recurrence 10 years or longer after surgery, raising the possibility that postop follow-up should never end, according to a study presented at the annual meeting of the American Association of Endocrine Surgeons.

Dr. Irene Lou of the University of Wisconsin–Madison reported on results of a retrospective study of 196 patients who had a presumably “curative” parathyroidectomy at the institution between November 2000 and June 2005. The mean age of the study population was 61 years.

“The long-term recurrences of primary hyperparathyroidism after curative parathyroidectomy is likely higher than previously reported, with over a third of recurrences occurring 10 years after their operation,” Dr. Lou said.

The study also identified independent predictors of recurrence, among them younger age, a drop in intraoperative parathyroid hormone less than 70%, and double adenoma, Dr. Lou said. All patients after parathyroidectomy should have at minimum an annual serum calcium test, especially younger patients with longer life expectancies, she said. This recommendation, however, may be altered for older patients or those with additional comorbidities.

The study defined recurrence as serum calcium of 10.2 mg/dL or greater 6 months or longer after the initial operation. The overall 10-year recurrence rate was 14.8% and the median time to recurrence was 6.3 years. “We found that 41.4% of patients who recurred did so by 5 years and 65.5% by 10 years,” Dr. Lou said.

The University of Wisconsin and University of Alabama at Birmingham investigators undertook the study because the recent data on recurrence was limited, with the longest study topping out at 7 years, Dr. Lou said. “We previously looked at this problem in other perspectives and we found that a lot of curves separated at around 8 years,” she said.

With regard to the type of operation the patients had, whether unilateral minimally invasive parathyroidectomy or bilateral open surgery, the study found no significant differences in recurrence rates, Dr. Lou said. “This is an excellent study,” Dr. Samuel K. Snyder of Temple, Tex., said during the discussion. “You’re telling us we need to follow patients much longer than perhaps we did previously, but we all see patients who have normal calcium and still have a residual elevated parathyroid hormone level.” He asked if the study considered parathyroid hormone levels at 6 months or more after surgery or vitamin D levels, but Dr. Lou said this information was not available, therefore could not be evaluated.

Dr. Lou and her coauthors had no financial relationships to disclose.

Extubated patients who either received noninvasive ventilation (NIV) therapy or high-flow nasal cannula oxygen had a lower risk of reintubation, compared with extubated patients who received some form of standard oxygen therapy, according to the results of two multicenter, randomized clinical trials published online in JAMA.

Participants in one of the studies, which included abdominal surgery patients diagnosed with respiratory failure within 7 days following surgery, either received NIV or standard oxygen therapy for 30 days or until ICU discharge, whichever came first. While NIV has been effectively used to treat nonsurgical patients with acute exacerbations of chronic obstructive pulmonary disease and cardiogenic pulmonary edema, there is no evidence to support the use of NIV in surgical patients with hypoxemic acute respiratory failure after abdominal surgery, according to Dr. Samir Jaber of the Saint Eloi University Hospital and Montpellier School of Medicine, both in Montpellier, France, and his colleagues (JAMA. 2016 Apr 5;315[13]:1345-53).

The second study included adult patients who had received mechanical ventilation for more than 12 hours and who met criteria for being considered at low risk for reintubation. Patients were administered either high-flow oxygen therapy through nasal cannula immediately after extubation or continuous conventional oxygen therapy through nasal cannula or nonrebreather facemask; the patients were observed for 72 hours. High-flow therapy has been shown to improve oxygenation and survival in clinical studies of critically ill patients in the acute phase of respiratory failure. “[A study by S.M. Maggiore and his colleagues (Am J Respir Crit Care Med. 2014;190(3):282-8)] suggested that high-flow therapy after planned extubation decreased the reintubation rate in a general population of critical patients, but the benefits might be mainly attributable to improvements in high-risk patients,” said Dr. Gonzalo Hernandez, of the Hospital Virgen de la Salud, Toledo, Spain, and his colleagues (JAMA. 2016 Apr 5;315[13]:1354-61).

In the first study, 148 patients received NIV and 145 patients received standard oxygen therapy only. NIV was administered through a facemask connected to an ICU- or a NIV-dedicated ventilator, using either a heated humidifier or heat and moisture exchanger to warm and humidify inspired gases. Patients were encouraged to use NIV for 6 hours during the first 24 hours of the study and received standard oxygen therapy at a rate of up to 15 L/minute to maintain an arterial oxygen saturation estimate (SpO₂) of at least 94% in between NIV sessions. NIV was started at an inspiratory positive airway pressure of 5 cm H₂O, increasing to a maximum inspiratory pressure of 15 cm H₂O, aiming to achieve an expiratory tidal volume between 6 and 8 mL/kg of predicted body weight and a respiratory rate lower than 25/min. The patients in this study’s control group only received the standard oxygen therapy.

In the other study, 263 patients received conventional therapy, with the oxygen flow having been adjusted to maintain an arterial oxygen saturation estimate of greater than 92%. This study’s other 264 patients received high-flow oxygen therapy, with the flow having been initially set at 10 L/min and titrated upward in 5-L/min steps until patients experienced discomfort. The high-flow therapy was stopped after 24 hours and was followed by conventional oxygen therapy, when needed.

The primary outcome measure in the study involving NIV was cause for reintubation within 7 days of randomization.

Secondary outcome measures included gas exchange, healthcare-associated infection rate within 30 days, number of ventilator-free days between days 1 and 30, antibiotic use duration, ICU and in-hospital length of stay, and 30- and 90-day mortality.

Reintubation occurred in 49 patients in the NIV group and 66 patients in the standard oxygen therapy group, a significant difference (P = .03). Among the reintubated patients, those who had received NIV spent less time under invasive mechanical ventilation as did the patients given standard oxygen therapy. The interquartile ranges of days of invasive mechanical ventilation were 0-3 for patients in the NIV group and 0-5 for patients in the standard oxygen therapy group (P = .05). At 30 days, NIV was associated with significantly more ventilator-free days than standard oxygen therapy (25.4 vs. 23.2; P = .04). At 90 days, 22 patients in the NIV group and 31 patients in the standard oxygen therapy group had died (P = .15).

“Recent high-impact trials have demonstrated the benefits in nonsurgical hypoxemic respiratory failure or equivalence of high-flow nasal cannula compared with NIV in patients after cardiothoracic surgery with moderate to severe hypoxemia. Future studies comparing use of high-flow oxygen cannula vs standard oxygen therapy and NIV for patients after abdominal surgery as preventive (prophylactic) or curative applications are needed,” according to Dr. Jaber and his colleagues.

The primary outcome measure for the study of patients receiving high-flow oxygen therapy was reintubation within 72 hours after extubation; this occurred in fewer patients in the high-flow oxygen group than in the conventional therapy group (13 or 4.9% vs. 32 or 12.2%.) This statistically significant difference was mainly attributable to a lower incidence of respiratory-related reintubation in the high-flow group, compared with the conventional therapy group (1.5% vs. 8.7%), said Dr. Hernandez and his colleagues.

Secondary outcome measures included postextubation respiratory failure, respiratory infection, sepsis, multiorgan failure, ICU and hospital length of stay and mortality, time to reintubation, and adverse effects. Postintubation respiratory failure was less common in the high-flow therapy group than in the conventional therapy group (22 patients or 8.3% vs. 38 or 14.4%). Differences between the two groups in other secondary outcomes were not statistically significant.

“The main finding of this study was that high-flow oxygen significantly reduced the reintubation rate in critically ill patients at low risk for extubation failure ... High-flow therapy improves oxygenation, and the lower rate of reintubation secondary to hypoxia in the high-flow group corroborates this finding. High-flow oxygen also seems to reduce other causes of respiratory failure such as increased work of breathing and respiratory muscle fatigue, which are frequently associated with reintubation secondary to hypoxia. Another way in which high-flow therapy improves extubation outcome is by conditioning the inspired gas,” said Dr. Hernandez and his colleagues.

No adverse events were reported in either study.

Dr. Hernandez and his colleagues reported no conflicts of interest. Dr. Jaber and his colleagues disclosed no potential conflicts of interest with their study’s sponsors, Montpellier (France) University Hospital and the APARD Foundation.

[email protected]

Extubated patients who either received noninvasive ventilation (NIV) therapy or high-flow nasal cannula oxygen had a lower risk of reintubation, compared with extubated patients who received some form of standard oxygen therapy, according to the results of two multicenter, randomized clinical trials published online in JAMA.

Participants in one of the studies, which included abdominal surgery patients diagnosed with respiratory failure within 7 days following surgery, either received NIV or standard oxygen therapy for 30 days or until ICU discharge, whichever came first. While NIV has been effectively used to treat nonsurgical patients with acute exacerbations of chronic obstructive pulmonary disease and cardiogenic pulmonary edema, there is no evidence to support the use of NIV in surgical patients with hypoxemic acute respiratory failure after abdominal surgery, according to Dr. Samir Jaber of the Saint Eloi University Hospital and Montpellier School of Medicine, both in Montpellier, France, and his colleagues (JAMA. 2016 Apr 5;315[13]:1345-53).

The second study included adult patients who had received mechanical ventilation for more than 12 hours and who met criteria for being considered at low risk for reintubation. Patients were administered either high-flow oxygen therapy through nasal cannula immediately after extubation or continuous conventional oxygen therapy through nasal cannula or nonrebreather facemask; the patients were observed for 72 hours. High-flow therapy has been shown to improve oxygenation and survival in clinical studies of critically ill patients in the acute phase of respiratory failure. “[A study by S.M. Maggiore and his colleagues (Am J Respir Crit Care Med. 2014;190(3):282-8)] suggested that high-flow therapy after planned extubation decreased the reintubation rate in a general population of critical patients, but the benefits might be mainly attributable to improvements in high-risk patients,” said Dr. Gonzalo Hernandez, of the Hospital Virgen de la Salud, Toledo, Spain, and his colleagues (JAMA. 2016 Apr 5;315[13]:1354-61).

In the first study, 148 patients received NIV and 145 patients received standard oxygen therapy only. NIV was administered through a facemask connected to an ICU- or a NIV-dedicated ventilator, using either a heated humidifier or heat and moisture exchanger to warm and humidify inspired gases. Patients were encouraged to use NIV for 6 hours during the first 24 hours of the study and received standard oxygen therapy at a rate of up to 15 L/minute to maintain an arterial oxygen saturation estimate (SpO₂) of at least 94% in between NIV sessions. NIV was started at an inspiratory positive airway pressure of 5 cm H₂O, increasing to a maximum inspiratory pressure of 15 cm H₂O, aiming to achieve an expiratory tidal volume between 6 and 8 mL/kg of predicted body weight and a respiratory rate lower than 25/min. The patients in this study’s control group only received the standard oxygen therapy.

In the other study, 263 patients received conventional therapy, with the oxygen flow having been adjusted to maintain an arterial oxygen saturation estimate of greater than 92%. This study’s other 264 patients received high-flow oxygen therapy, with the flow having been initially set at 10 L/min and titrated upward in 5-L/min steps until patients experienced discomfort. The high-flow therapy was stopped after 24 hours and was followed by conventional oxygen therapy, when needed.

The primary outcome measure in the study involving NIV was cause for reintubation within 7 days of randomization.

Secondary outcome measures included gas exchange, healthcare-associated infection rate within 30 days, number of ventilator-free days between days 1 and 30, antibiotic use duration, ICU and in-hospital length of stay, and 30- and 90-day mortality.

Reintubation occurred in 49 patients in the NIV group and 66 patients in the standard oxygen therapy group, a significant difference (P = .03). Among the reintubated patients, those who had received NIV spent less time under invasive mechanical ventilation as did the patients given standard oxygen therapy. The interquartile ranges of days of invasive mechanical ventilation were 0-3 for patients in the NIV group and 0-5 for patients in the standard oxygen therapy group (P = .05). At 30 days, NIV was associated with significantly more ventilator-free days than standard oxygen therapy (25.4 vs. 23.2; P = .04). At 90 days, 22 patients in the NIV group and 31 patients in the standard oxygen therapy group had died (P = .15).

“Recent high-impact trials have demonstrated the benefits in nonsurgical hypoxemic respiratory failure or equivalence of high-flow nasal cannula compared with NIV in patients after cardiothoracic surgery with moderate to severe hypoxemia. Future studies comparing use of high-flow oxygen cannula vs standard oxygen therapy and NIV for patients after abdominal surgery as preventive (prophylactic) or curative applications are needed,” according to Dr. Jaber and his colleagues.

The primary outcome measure for the study of patients receiving high-flow oxygen therapy was reintubation within 72 hours after extubation; this occurred in fewer patients in the high-flow oxygen group than in the conventional therapy group (13 or 4.9% vs. 32 or 12.2%.) This statistically significant difference was mainly attributable to a lower incidence of respiratory-related reintubation in the high-flow group, compared with the conventional therapy group (1.5% vs. 8.7%), said Dr. Hernandez and his colleagues.

Secondary outcome measures included postextubation respiratory failure, respiratory infection, sepsis, multiorgan failure, ICU and hospital length of stay and mortality, time to reintubation, and adverse effects. Postintubation respiratory failure was less common in the high-flow therapy group than in the conventional therapy group (22 patients or 8.3% vs. 38 or 14.4%). Differences between the two groups in other secondary outcomes were not statistically significant.

“The main finding of this study was that high-flow oxygen significantly reduced the reintubation rate in critically ill patients at low risk for extubation failure ... High-flow therapy improves oxygenation, and the lower rate of reintubation secondary to hypoxia in the high-flow group corroborates this finding. High-flow oxygen also seems to reduce other causes of respiratory failure such as increased work of breathing and respiratory muscle fatigue, which are frequently associated with reintubation secondary to hypoxia. Another way in which high-flow therapy improves extubation outcome is by conditioning the inspired gas,” said Dr. Hernandez and his colleagues.

No adverse events were reported in either study.

Dr. Hernandez and his colleagues reported no conflicts of interest. Dr. Jaber and his colleagues disclosed no potential conflicts of interest with their study’s sponsors, Montpellier (France) University Hospital and the APARD Foundation.

[email protected]

Extubated patients who either received noninvasive ventilation (NIV) therapy or high-flow nasal cannula oxygen had a lower risk of reintubation, compared with extubated patients who received some form of standard oxygen therapy, according to the results of two multicenter, randomized clinical trials published online in JAMA.

Participants in one of the studies, which included abdominal surgery patients diagnosed with respiratory failure within 7 days following surgery, either received NIV or standard oxygen therapy for 30 days or until ICU discharge, whichever came first. While NIV has been effectively used to treat nonsurgical patients with acute exacerbations of chronic obstructive pulmonary disease and cardiogenic pulmonary edema, there is no evidence to support the use of NIV in surgical patients with hypoxemic acute respiratory failure after abdominal surgery, according to Dr. Samir Jaber of the Saint Eloi University Hospital and Montpellier School of Medicine, both in Montpellier, France, and his colleagues (JAMA. 2016 Apr 5;315[13]:1345-53).

The second study included adult patients who had received mechanical ventilation for more than 12 hours and who met criteria for being considered at low risk for reintubation. Patients were administered either high-flow oxygen therapy through nasal cannula immediately after extubation or continuous conventional oxygen therapy through nasal cannula or nonrebreather facemask; the patients were observed for 72 hours. High-flow therapy has been shown to improve oxygenation and survival in clinical studies of critically ill patients in the acute phase of respiratory failure. “[A study by S.M. Maggiore and his colleagues (Am J Respir Crit Care Med. 2014;190(3):282-8)] suggested that high-flow therapy after planned extubation decreased the reintubation rate in a general population of critical patients, but the benefits might be mainly attributable to improvements in high-risk patients,” said Dr. Gonzalo Hernandez, of the Hospital Virgen de la Salud, Toledo, Spain, and his colleagues (JAMA. 2016 Apr 5;315[13]:1354-61).

In the first study, 148 patients received NIV and 145 patients received standard oxygen therapy only. NIV was administered through a facemask connected to an ICU- or a NIV-dedicated ventilator, using either a heated humidifier or heat and moisture exchanger to warm and humidify inspired gases. Patients were encouraged to use NIV for 6 hours during the first 24 hours of the study and received standard oxygen therapy at a rate of up to 15 L/minute to maintain an arterial oxygen saturation estimate (SpO₂) of at least 94% in between NIV sessions. NIV was started at an inspiratory positive airway pressure of 5 cm H₂O, increasing to a maximum inspiratory pressure of 15 cm H₂O, aiming to achieve an expiratory tidal volume between 6 and 8 mL/kg of predicted body weight and a respiratory rate lower than 25/min. The patients in this study’s control group only received the standard oxygen therapy.

In the other study, 263 patients received conventional therapy, with the oxygen flow having been adjusted to maintain an arterial oxygen saturation estimate of greater than 92%. This study’s other 264 patients received high-flow oxygen therapy, with the flow having been initially set at 10 L/min and titrated upward in 5-L/min steps until patients experienced discomfort. The high-flow therapy was stopped after 24 hours and was followed by conventional oxygen therapy, when needed.

The primary outcome measure in the study involving NIV was cause for reintubation within 7 days of randomization.

Secondary outcome measures included gas exchange, healthcare-associated infection rate within 30 days, number of ventilator-free days between days 1 and 30, antibiotic use duration, ICU and in-hospital length of stay, and 30- and 90-day mortality.

Reintubation occurred in 49 patients in the NIV group and 66 patients in the standard oxygen therapy group, a significant difference (P = .03). Among the reintubated patients, those who had received NIV spent less time under invasive mechanical ventilation as did the patients given standard oxygen therapy. The interquartile ranges of days of invasive mechanical ventilation were 0-3 for patients in the NIV group and 0-5 for patients in the standard oxygen therapy group (P = .05). At 30 days, NIV was associated with significantly more ventilator-free days than standard oxygen therapy (25.4 vs. 23.2; P = .04). At 90 days, 22 patients in the NIV group and 31 patients in the standard oxygen therapy group had died (P = .15).

“Recent high-impact trials have demonstrated the benefits in nonsurgical hypoxemic respiratory failure or equivalence of high-flow nasal cannula compared with NIV in patients after cardiothoracic surgery with moderate to severe hypoxemia. Future studies comparing use of high-flow oxygen cannula vs standard oxygen therapy and NIV for patients after abdominal surgery as preventive (prophylactic) or curative applications are needed,” according to Dr. Jaber and his colleagues.

The primary outcome measure for the study of patients receiving high-flow oxygen therapy was reintubation within 72 hours after extubation; this occurred in fewer patients in the high-flow oxygen group than in the conventional therapy group (13 or 4.9% vs. 32 or 12.2%.) This statistically significant difference was mainly attributable to a lower incidence of respiratory-related reintubation in the high-flow group, compared with the conventional therapy group (1.5% vs. 8.7%), said Dr. Hernandez and his colleagues.

Secondary outcome measures included postextubation respiratory failure, respiratory infection, sepsis, multiorgan failure, ICU and hospital length of stay and mortality, time to reintubation, and adverse effects. Postintubation respiratory failure was less common in the high-flow therapy group than in the conventional therapy group (22 patients or 8.3% vs. 38 or 14.4%). Differences between the two groups in other secondary outcomes were not statistically significant.

“The main finding of this study was that high-flow oxygen significantly reduced the reintubation rate in critically ill patients at low risk for extubation failure ... High-flow therapy improves oxygenation, and the lower rate of reintubation secondary to hypoxia in the high-flow group corroborates this finding. High-flow oxygen also seems to reduce other causes of respiratory failure such as increased work of breathing and respiratory muscle fatigue, which are frequently associated with reintubation secondary to hypoxia. Another way in which high-flow therapy improves extubation outcome is by conditioning the inspired gas,” said Dr. Hernandez and his colleagues.

No adverse events were reported in either study.

Dr. Hernandez and his colleagues reported no conflicts of interest. Dr. Jaber and his colleagues disclosed no potential conflicts of interest with their study’s sponsors, Montpellier (France) University Hospital and the APARD Foundation.

[email protected]

LOS ANGELES – A new Cochrane systematic review and meta-analysis has concluded there is no consistent evidence that specific allergen immunotherapy is beneficial in patients with atopic dermatitis, Dr. Herman H. Tam reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“We know that for specific allergen immunotherapy, there have been really good results in allergic rhinitis and venom allergy. For atopic dermatitis, however, dating back almost 40 years, we found there have only been 12 randomized trials using standardized allergen extracts. The quality of evidence was low, and the study findings have been inconsistent,” Dr. Tam, first author of the Cochrane review, said in an interview.

Bruce Jancin/Frontline Medical News

The dozen trials included a total of 733 children and adults in nine countries. Because of insufficient follow-up in most of the studies, coupled with the use of a variety of endpoints, the analysis concluded that “specific allergen immunotherapy cannot be recommended for atopic eczema at present” (Cochrane Database Syst Rev. 2016 Feb 12;2:CD008774).

“We found no consistent evidence that specific allergen immunotherapy provides a treatment benefit for people with allergic eczema, compared with placebo or no treatment. The message of this review is that we need more large randomized trials with better controls, modern high-quality allergen extracts that have proven themselves in other allergic diseases, and patient-centered outcome measures,” according to Dr. Tam, who participated in the Cochrane review while at Imperial College London and is now a pediatric resident at the University of Manitoba, Winnipeg.

He reported having no relevant financial conflicts.

[email protected]

LOS ANGELES – A new Cochrane systematic review and meta-analysis has concluded there is no consistent evidence that specific allergen immunotherapy is beneficial in patients with atopic dermatitis, Dr. Herman H. Tam reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“We know that for specific allergen immunotherapy, there have been really good results in allergic rhinitis and venom allergy. For atopic dermatitis, however, dating back almost 40 years, we found there have only been 12 randomized trials using standardized allergen extracts. The quality of evidence was low, and the study findings have been inconsistent,” Dr. Tam, first author of the Cochrane review, said in an interview.

Bruce Jancin/Frontline Medical News

The dozen trials included a total of 733 children and adults in nine countries. Because of insufficient follow-up in most of the studies, coupled with the use of a variety of endpoints, the analysis concluded that “specific allergen immunotherapy cannot be recommended for atopic eczema at present” (Cochrane Database Syst Rev. 2016 Feb 12;2:CD008774).

“We found no consistent evidence that specific allergen immunotherapy provides a treatment benefit for people with allergic eczema, compared with placebo or no treatment. The message of this review is that we need more large randomized trials with better controls, modern high-quality allergen extracts that have proven themselves in other allergic diseases, and patient-centered outcome measures,” according to Dr. Tam, who participated in the Cochrane review while at Imperial College London and is now a pediatric resident at the University of Manitoba, Winnipeg.

He reported having no relevant financial conflicts.

[email protected]

LOS ANGELES – A new Cochrane systematic review and meta-analysis has concluded there is no consistent evidence that specific allergen immunotherapy is beneficial in patients with atopic dermatitis, Dr. Herman H. Tam reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“We know that for specific allergen immunotherapy, there have been really good results in allergic rhinitis and venom allergy. For atopic dermatitis, however, dating back almost 40 years, we found there have only been 12 randomized trials using standardized allergen extracts. The quality of evidence was low, and the study findings have been inconsistent,” Dr. Tam, first author of the Cochrane review, said in an interview.

Bruce Jancin/Frontline Medical News

The dozen trials included a total of 733 children and adults in nine countries. Because of insufficient follow-up in most of the studies, coupled with the use of a variety of endpoints, the analysis concluded that “specific allergen immunotherapy cannot be recommended for atopic eczema at present” (Cochrane Database Syst Rev. 2016 Feb 12;2:CD008774).

“We found no consistent evidence that specific allergen immunotherapy provides a treatment benefit for people with allergic eczema, compared with placebo or no treatment. The message of this review is that we need more large randomized trials with better controls, modern high-quality allergen extracts that have proven themselves in other allergic diseases, and patient-centered outcome measures,” according to Dr. Tam, who participated in the Cochrane review while at Imperial College London and is now a pediatric resident at the University of Manitoba, Winnipeg.

He reported having no relevant financial conflicts.

[email protected]