multiple myeloma

BOSTON—Early results from a phase 1 trial suggest the chimeric antigen receptor (CAR) T-cell therapy P-BCMA-101 can produce responses in patients with relapsed/refractory multiple myeloma (MM).

All 11 patients treated have experienced some clinical response, with 8 patients achieving a partial response (PR) or better.

The most common adverse events were neutropenia and thrombocytopenia. One patient was suspected to have cytokine release syndrome, but the condition resolved without use of tociluzimab or steroids.

These results were presented at the 2018 CAR-TCR Summit by Eric Ostertag, MD, PhD, chief executive officer of Poseida Therapeutics Inc., the company developing P-BCMA-101.

Dr. Ostertag presented data on 11 patients with heavily pretreated MM. They had a median of six prior therapies. Their median age was 60, and 73% were considered high risk.

Prior to receiving P-BCMA-101, patients received conditioning with fludarabine (30 mg/m²) and cyclophosphamide (300 mg/m²) for 3 days.

Patients were then treated across three dose groups with average CAR T-cell doses of 51×10⁶ (n=3), 152×10⁶ (n=7), and 430×10⁶ (n=1).

As of August 10, 2018, all 11 patients were still on study.

There were no dose-limiting toxicities. Eight patients developed neutropenia, and 5 had thrombocytopenia.

Researchers suspected cytokine release syndrome in one patient, but the condition resolved without tociluzimab or steroid treatment. There was no neurotoxicity reported, and none of the patients required admission to an intensive care unit.

All patients showed improvement in biomarkers following treatment.

Ten patients were evaluable for response by International Myeloma Working Group criteria. Seven of these patients achieved at least a PR, including very good partial responses (VGPRs) and stringent complete response (CR).

The eleventh patient also responded to treatment, but this patient has oligosecretory disease and was only evaluable by PET. The patient had a near-CR by PET.

Poseida Therapeutics would not disclose additional details regarding how many patients achieved a PR, VGPR, or CR, but the company plans to release more information on response at an upcoming meeting.

“The latest data results show that P-BCMA-101 induces deep responses in a heavily pretreated population with relapsed/refractory multiple myeloma, with some patients reaching VGPR and even stringent CR at early efficacy assessments,” Dr. Ostertag said.

“We believe our advantages of a purified product, where all cells express the CAR molecule, and a product with high levels of stem cell memory T cells, producing a more gradual and prolonged immune response against tumor cells, provide a significantly better therapeutic index when compared with other CAR-T therapeutics. We are also encouraged that P-BCMA-101 is demonstrating significant efficacy even at doses that have been ineffective for other anti-BCMA CAR-T therapies and that our response rates continue to improve as the dose increases.”

This study (NCT03288493) is funded by the California Institute for Regenerative Medicine and Poseida Therapeutics.

multiple myeloma

BOSTON—Early results from a phase 1 trial suggest the chimeric antigen receptor (CAR) T-cell therapy P-BCMA-101 can produce responses in patients with relapsed/refractory multiple myeloma (MM).

All 11 patients treated have experienced some clinical response, with 8 patients achieving a partial response (PR) or better.

The most common adverse events were neutropenia and thrombocytopenia. One patient was suspected to have cytokine release syndrome, but the condition resolved without use of tociluzimab or steroids.

These results were presented at the 2018 CAR-TCR Summit by Eric Ostertag, MD, PhD, chief executive officer of Poseida Therapeutics Inc., the company developing P-BCMA-101.

Dr. Ostertag presented data on 11 patients with heavily pretreated MM. They had a median of six prior therapies. Their median age was 60, and 73% were considered high risk.

Prior to receiving P-BCMA-101, patients received conditioning with fludarabine (30 mg/m²) and cyclophosphamide (300 mg/m²) for 3 days.

Patients were then treated across three dose groups with average CAR T-cell doses of 51×10⁶ (n=3), 152×10⁶ (n=7), and 430×10⁶ (n=1).

As of August 10, 2018, all 11 patients were still on study.

There were no dose-limiting toxicities. Eight patients developed neutropenia, and 5 had thrombocytopenia.

Researchers suspected cytokine release syndrome in one patient, but the condition resolved without tociluzimab or steroid treatment. There was no neurotoxicity reported, and none of the patients required admission to an intensive care unit.

All patients showed improvement in biomarkers following treatment.

Ten patients were evaluable for response by International Myeloma Working Group criteria. Seven of these patients achieved at least a PR, including very good partial responses (VGPRs) and stringent complete response (CR).

The eleventh patient also responded to treatment, but this patient has oligosecretory disease and was only evaluable by PET. The patient had a near-CR by PET.

Poseida Therapeutics would not disclose additional details regarding how many patients achieved a PR, VGPR, or CR, but the company plans to release more information on response at an upcoming meeting.

“The latest data results show that P-BCMA-101 induces deep responses in a heavily pretreated population with relapsed/refractory multiple myeloma, with some patients reaching VGPR and even stringent CR at early efficacy assessments,” Dr. Ostertag said.

“We believe our advantages of a purified product, where all cells express the CAR molecule, and a product with high levels of stem cell memory T cells, producing a more gradual and prolonged immune response against tumor cells, provide a significantly better therapeutic index when compared with other CAR-T therapeutics. We are also encouraged that P-BCMA-101 is demonstrating significant efficacy even at doses that have been ineffective for other anti-BCMA CAR-T therapies and that our response rates continue to improve as the dose increases.”

This study (NCT03288493) is funded by the California Institute for Regenerative Medicine and Poseida Therapeutics.

multiple myeloma

BOSTON—Early results from a phase 1 trial suggest the chimeric antigen receptor (CAR) T-cell therapy P-BCMA-101 can produce responses in patients with relapsed/refractory multiple myeloma (MM).

All 11 patients treated have experienced some clinical response, with 8 patients achieving a partial response (PR) or better.

The most common adverse events were neutropenia and thrombocytopenia. One patient was suspected to have cytokine release syndrome, but the condition resolved without use of tociluzimab or steroids.

These results were presented at the 2018 CAR-TCR Summit by Eric Ostertag, MD, PhD, chief executive officer of Poseida Therapeutics Inc., the company developing P-BCMA-101.

Dr. Ostertag presented data on 11 patients with heavily pretreated MM. They had a median of six prior therapies. Their median age was 60, and 73% were considered high risk.

Prior to receiving P-BCMA-101, patients received conditioning with fludarabine (30 mg/m²) and cyclophosphamide (300 mg/m²) for 3 days.

Patients were then treated across three dose groups with average CAR T-cell doses of 51×10⁶ (n=3), 152×10⁶ (n=7), and 430×10⁶ (n=1).

As of August 10, 2018, all 11 patients were still on study.

There were no dose-limiting toxicities. Eight patients developed neutropenia, and 5 had thrombocytopenia.

Researchers suspected cytokine release syndrome in one patient, but the condition resolved without tociluzimab or steroid treatment. There was no neurotoxicity reported, and none of the patients required admission to an intensive care unit.

All patients showed improvement in biomarkers following treatment.

Ten patients were evaluable for response by International Myeloma Working Group criteria. Seven of these patients achieved at least a PR, including very good partial responses (VGPRs) and stringent complete response (CR).

The eleventh patient also responded to treatment, but this patient has oligosecretory disease and was only evaluable by PET. The patient had a near-CR by PET.

Poseida Therapeutics would not disclose additional details regarding how many patients achieved a PR, VGPR, or CR, but the company plans to release more information on response at an upcoming meeting.

“The latest data results show that P-BCMA-101 induces deep responses in a heavily pretreated population with relapsed/refractory multiple myeloma, with some patients reaching VGPR and even stringent CR at early efficacy assessments,” Dr. Ostertag said.

“We believe our advantages of a purified product, where all cells express the CAR molecule, and a product with high levels of stem cell memory T cells, producing a more gradual and prolonged immune response against tumor cells, provide a significantly better therapeutic index when compared with other CAR-T therapeutics. We are also encouraged that P-BCMA-101 is demonstrating significant efficacy even at doses that have been ineffective for other anti-BCMA CAR-T therapies and that our response rates continue to improve as the dose increases.”

This study (NCT03288493) is funded by the California Institute for Regenerative Medicine and Poseida Therapeutics.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

[email protected]

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

[email protected]

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

[email protected]

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.

PARIS – Adjunctive oral pantothenic acid prolonged the beneficial effects of oral antibiotic therapy for moderate to severe acne vulgaris in a randomized, double-blind, placebo-controlled trial, Maria A. Santos, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The beauty of this treatment strategy is that it enables acne patients to obtain the therapeutic benefits of oral antibiotic therapy while minimizing exposure in accord with the current push to curb the growing problem of antibiotic resistance. Indeed, adjunctive oral pantothenic acid (also known as vitamin B₅) appears to offer a solution to the high rate of clinical deterioration that often follows antibiotic discontinuation, observed Dr. Santos, a dermatologist at University of Santo Tomas Hospital in Manila.

“The use of pantothenic acid as an adjunct may enhance acne therapy and possibly prolong control despite antibiotic discontinuation,” she said.

Dr. Santos reported on 40 patients aged 16-45 years with moderate to severe acne who were randomized to 2 g/day of pantothenic acid or placebo for 16 weeks on top of 6 weeks of oral doxycycline at 100 mg once daily, plus ongoing topical adapalene and benzoyl peroxide gel.

After 8 weeks – that is, 2 weeks after everyone completed 6 weeks on doxycycline – the mean reduction in noninflammatory and total lesion counts was virtually identical in the two groups. For example, there was a 57.7% decrease in total lesion count compared with baseline in the pantothenic acid group and a 55% reduction in placebo-treated controls. Thereafter, however, the response curves diverged. Backsliding occurred in the control group such that their mean reduction in total lesions was 48.4% at 14 weeks and 40.4% at 16 weeks, compared with baseline. In contrast, patients on daily pantothenic acid had a 78.7% reduction in total lesion count at 14 weeks and an 80% decrease from baseline at 16 weeks.

Similarly, at 16 weeks, the mean reduction in noninflammatory lesions was 49% in the pantothenic acid group versus 19.2% in controls, compared with 34%-36% reductions at 10 weeks, even though all patients remained on topical adapalene and benzoyl peroxide throughout.

Mean reduction in inflammatory lesions followed the same trend; however, the numeric advantage in the pantothenic acid group didn’t achieve statistical significance.

Median Dermatology Life Quality Index scores improved over the course of the study in both groups, although significantly more patients in the pantothenic acid group achieved at least a 4-point improvement over baseline, which is considered the minimum clinically important difference. Moreover, while modified Global Severity Scores and subjective self-assessment scores improved in both groups, from week 12 onwards, the improvements were significantly greater in the pantothenic acid group.

Receiving adjunctive pantothenic acid for 10 weeks was safe. Adverse events were the same in both study arms, consisting chiefly of mild erythema, scaling, dryness, and nausea during the initial weeks on doxycycline.

Pantothenic acid is a water-soluble essential nutrient. Dr. Santos said that while the precise mechanism of the benefit seen in this randomized trial isn’t known, other investigators have generated evidence suggestive of enhanced epidermal barrier function through normalization of keratinocyte proliferation and differentiation in acne patients, coupled with antioxidant and anti-inflammatory effects.

Dr. Santos reported having no financial conflicts regarding her study, conducted free of commercial support.
 

[email protected]

PARIS – Adjunctive oral pantothenic acid prolonged the beneficial effects of oral antibiotic therapy for moderate to severe acne vulgaris in a randomized, double-blind, placebo-controlled trial, Maria A. Santos, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The beauty of this treatment strategy is that it enables acne patients to obtain the therapeutic benefits of oral antibiotic therapy while minimizing exposure in accord with the current push to curb the growing problem of antibiotic resistance. Indeed, adjunctive oral pantothenic acid (also known as vitamin B₅) appears to offer a solution to the high rate of clinical deterioration that often follows antibiotic discontinuation, observed Dr. Santos, a dermatologist at University of Santo Tomas Hospital in Manila.

“The use of pantothenic acid as an adjunct may enhance acne therapy and possibly prolong control despite antibiotic discontinuation,” she said.

Dr. Santos reported on 40 patients aged 16-45 years with moderate to severe acne who were randomized to 2 g/day of pantothenic acid or placebo for 16 weeks on top of 6 weeks of oral doxycycline at 100 mg once daily, plus ongoing topical adapalene and benzoyl peroxide gel.

After 8 weeks – that is, 2 weeks after everyone completed 6 weeks on doxycycline – the mean reduction in noninflammatory and total lesion counts was virtually identical in the two groups. For example, there was a 57.7% decrease in total lesion count compared with baseline in the pantothenic acid group and a 55% reduction in placebo-treated controls. Thereafter, however, the response curves diverged. Backsliding occurred in the control group such that their mean reduction in total lesions was 48.4% at 14 weeks and 40.4% at 16 weeks, compared with baseline. In contrast, patients on daily pantothenic acid had a 78.7% reduction in total lesion count at 14 weeks and an 80% decrease from baseline at 16 weeks.

Similarly, at 16 weeks, the mean reduction in noninflammatory lesions was 49% in the pantothenic acid group versus 19.2% in controls, compared with 34%-36% reductions at 10 weeks, even though all patients remained on topical adapalene and benzoyl peroxide throughout.

Mean reduction in inflammatory lesions followed the same trend; however, the numeric advantage in the pantothenic acid group didn’t achieve statistical significance.

Median Dermatology Life Quality Index scores improved over the course of the study in both groups, although significantly more patients in the pantothenic acid group achieved at least a 4-point improvement over baseline, which is considered the minimum clinically important difference. Moreover, while modified Global Severity Scores and subjective self-assessment scores improved in both groups, from week 12 onwards, the improvements were significantly greater in the pantothenic acid group.

Receiving adjunctive pantothenic acid for 10 weeks was safe. Adverse events were the same in both study arms, consisting chiefly of mild erythema, scaling, dryness, and nausea during the initial weeks on doxycycline.

Pantothenic acid is a water-soluble essential nutrient. Dr. Santos said that while the precise mechanism of the benefit seen in this randomized trial isn’t known, other investigators have generated evidence suggestive of enhanced epidermal barrier function through normalization of keratinocyte proliferation and differentiation in acne patients, coupled with antioxidant and anti-inflammatory effects.

Dr. Santos reported having no financial conflicts regarding her study, conducted free of commercial support.
 

[email protected]

PARIS – Adjunctive oral pantothenic acid prolonged the beneficial effects of oral antibiotic therapy for moderate to severe acne vulgaris in a randomized, double-blind, placebo-controlled trial, Maria A. Santos, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The beauty of this treatment strategy is that it enables acne patients to obtain the therapeutic benefits of oral antibiotic therapy while minimizing exposure in accord with the current push to curb the growing problem of antibiotic resistance. Indeed, adjunctive oral pantothenic acid (also known as vitamin B₅) appears to offer a solution to the high rate of clinical deterioration that often follows antibiotic discontinuation, observed Dr. Santos, a dermatologist at University of Santo Tomas Hospital in Manila.

“The use of pantothenic acid as an adjunct may enhance acne therapy and possibly prolong control despite antibiotic discontinuation,” she said.

Dr. Santos reported on 40 patients aged 16-45 years with moderate to severe acne who were randomized to 2 g/day of pantothenic acid or placebo for 16 weeks on top of 6 weeks of oral doxycycline at 100 mg once daily, plus ongoing topical adapalene and benzoyl peroxide gel.

After 8 weeks – that is, 2 weeks after everyone completed 6 weeks on doxycycline – the mean reduction in noninflammatory and total lesion counts was virtually identical in the two groups. For example, there was a 57.7% decrease in total lesion count compared with baseline in the pantothenic acid group and a 55% reduction in placebo-treated controls. Thereafter, however, the response curves diverged. Backsliding occurred in the control group such that their mean reduction in total lesions was 48.4% at 14 weeks and 40.4% at 16 weeks, compared with baseline. In contrast, patients on daily pantothenic acid had a 78.7% reduction in total lesion count at 14 weeks and an 80% decrease from baseline at 16 weeks.

Similarly, at 16 weeks, the mean reduction in noninflammatory lesions was 49% in the pantothenic acid group versus 19.2% in controls, compared with 34%-36% reductions at 10 weeks, even though all patients remained on topical adapalene and benzoyl peroxide throughout.

Mean reduction in inflammatory lesions followed the same trend; however, the numeric advantage in the pantothenic acid group didn’t achieve statistical significance.

Median Dermatology Life Quality Index scores improved over the course of the study in both groups, although significantly more patients in the pantothenic acid group achieved at least a 4-point improvement over baseline, which is considered the minimum clinically important difference. Moreover, while modified Global Severity Scores and subjective self-assessment scores improved in both groups, from week 12 onwards, the improvements were significantly greater in the pantothenic acid group.

Receiving adjunctive pantothenic acid for 10 weeks was safe. Adverse events were the same in both study arms, consisting chiefly of mild erythema, scaling, dryness, and nausea during the initial weeks on doxycycline.

Pantothenic acid is a water-soluble essential nutrient. Dr. Santos said that while the precise mechanism of the benefit seen in this randomized trial isn’t known, other investigators have generated evidence suggestive of enhanced epidermal barrier function through normalization of keratinocyte proliferation and differentiation in acne patients, coupled with antioxidant and anti-inflammatory effects.

Dr. Santos reported having no financial conflicts regarding her study, conducted free of commercial support.
 

[email protected]

WASHINGTON – A strategy combining stewardship and science is needed to help combat antimicrobial resistance, and updated plans from the U.S. Food and Drug Administration include four key components to address all aspects of product development and use, FDA commissioner Scott Gottlieb, MD, said in a press briefing in Washington on Sept. 14. 

“The FDA plays a unique role in advancing human and animal health” that provides a unique vantage point for coordinating all aspects of product development and application, he said. 

The FDA’s comprehensive approach to the challenge of antimicrobial resistance (AMR) includes:

• Facilitating product development.
• Promoting antimicrobial stewardship.
• Supporting the development of new tools for surveillance.
• Advancing scientific initiatives, including research for the development of alternative treatments.

The FDA’s product development plan to combat AMR includes the creation of incentives for companies to develop new antibiotic products and create a robust pipeline, which is a challenge because of the lack of immediate economic gain, Dr. Gottlieb said.
“It necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains,” he emphasized. 

Strategies to incentivize companies include fast track designation, priority review, and breakthrough therapy designation. In addition, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) is designed to promote development of antimicrobial drugs for limited and underserved populations, Dr. Gottlieb said. The FDA plan also calls for pursuing reimbursement options with the Centers for Medicare & Medicaid Services. 

Promoting antimicrobial stewardship remains an ongoing element of the FDA’s plan to reduce AMR. In conjunction with the release of the FDA’s updated approach to AMR, the FDA’s Center for Veterinary Medicine CVM released a 5-year action plan to promote and support antimicrobial stewardship in not only the agricultural arena, but in companion animals as well. 

The FDA plans to bring all antimicrobials of medical importance that are approved for use in animals under the oversight of CVM, which will pursue the improve labeling on antimicrobial drugs used in the feed and water of food-producing animals, including defining durations of use, Dr. Gottlieb noted.

Supporting the development and improvement of surveillance tools is “essential to understanding the drivers of resistance in human and veterinary settings and formulating appropriate responses” to outbreaks, Dr. Gottlieb said.

To help meet this goal, the FDA will expand sampling via the National Antimicrobial Resistance Monitoring System (NARMS) database, he said. Other surveillance goals include supporting genomics research and expanding AMR monitoring to include pathogens associated with animal feed and companion animals, he added. 

As part of the final component of the FDA’s AMR strategy to advance scientific initiatives, the FDA has released a new Request for Information “to obtain additional, external input on how best to develop an annual list of regulatory science initiatives specific for antimicrobial products,” Dr. Gottlieb announced. The FDA intends to use the information gained from clinicians and others in its creation of guidance documents and recommendations to streamline the antibiotic development process. He also cited the FDA’s ongoing support of partnerships with public and private organizations such as the Clinical Trials Transformation Initiative, which focuses on drug development for severe bacterial infections with current unmet medical need.

“We need to harness science and policy to help our public health systems and researchers become nimbler in the battle against drug-resistant pathogens,” Dr. Gottlieb concluded. 

In a panel discussion following the briefing, several experts offered perspective on the FDA’s goals and on the challenges of AMR. 

William Flynn, DVM, deputy director of science policy for the Center of Veterinary Medicine, noted some goals for reducing the use of antibiotics in the veterinary arena. 

“We are trying to focus on the driver: What are the disease conditions that drive use of the product,” he said. Ideally, better management of disease conditions can reduce reliance on antibiotics, he added. 

Also in the panel discussion, Steven Gitterman, MD, deputy director of the division of microbiology devices at the Center for Devices and Radiological Health, emphasized the value of sustainable trial databases so AMR research can continue on an ongoing basis. Finally, Carolyn Wilson, PhD, associate director of research at the Center for Biologics Evaluation and Research, noted that the FDA’s research and development efforts include antibiotic alternatives, including live biotherapeutic products, fecal microbiota transplantation, and bacteriophage therapy.

Visit www.fda.gov for a transcript of Dr. Gottlieb’s talk, and for the updated FDA website page with more details on the agency’s plans to combat antimicrobial resistance. 

Dr. Gottlieb and the panelists had no financial conflicts to disclose.

WASHINGTON – A strategy combining stewardship and science is needed to help combat antimicrobial resistance, and updated plans from the U.S. Food and Drug Administration include four key components to address all aspects of product development and use, FDA commissioner Scott Gottlieb, MD, said in a press briefing in Washington on Sept. 14. 

“The FDA plays a unique role in advancing human and animal health” that provides a unique vantage point for coordinating all aspects of product development and application, he said. 

The FDA’s comprehensive approach to the challenge of antimicrobial resistance (AMR) includes:

• Facilitating product development.
• Promoting antimicrobial stewardship.
• Supporting the development of new tools for surveillance.
• Advancing scientific initiatives, including research for the development of alternative treatments.

The FDA’s product development plan to combat AMR includes the creation of incentives for companies to develop new antibiotic products and create a robust pipeline, which is a challenge because of the lack of immediate economic gain, Dr. Gottlieb said.
“It necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains,” he emphasized. 

Strategies to incentivize companies include fast track designation, priority review, and breakthrough therapy designation. In addition, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) is designed to promote development of antimicrobial drugs for limited and underserved populations, Dr. Gottlieb said. The FDA plan also calls for pursuing reimbursement options with the Centers for Medicare & Medicaid Services. 

Promoting antimicrobial stewardship remains an ongoing element of the FDA’s plan to reduce AMR. In conjunction with the release of the FDA’s updated approach to AMR, the FDA’s Center for Veterinary Medicine CVM released a 5-year action plan to promote and support antimicrobial stewardship in not only the agricultural arena, but in companion animals as well. 

The FDA plans to bring all antimicrobials of medical importance that are approved for use in animals under the oversight of CVM, which will pursue the improve labeling on antimicrobial drugs used in the feed and water of food-producing animals, including defining durations of use, Dr. Gottlieb noted.

Supporting the development and improvement of surveillance tools is “essential to understanding the drivers of resistance in human and veterinary settings and formulating appropriate responses” to outbreaks, Dr. Gottlieb said.

To help meet this goal, the FDA will expand sampling via the National Antimicrobial Resistance Monitoring System (NARMS) database, he said. Other surveillance goals include supporting genomics research and expanding AMR monitoring to include pathogens associated with animal feed and companion animals, he added. 

As part of the final component of the FDA’s AMR strategy to advance scientific initiatives, the FDA has released a new Request for Information “to obtain additional, external input on how best to develop an annual list of regulatory science initiatives specific for antimicrobial products,” Dr. Gottlieb announced. The FDA intends to use the information gained from clinicians and others in its creation of guidance documents and recommendations to streamline the antibiotic development process. He also cited the FDA’s ongoing support of partnerships with public and private organizations such as the Clinical Trials Transformation Initiative, which focuses on drug development for severe bacterial infections with current unmet medical need.

“We need to harness science and policy to help our public health systems and researchers become nimbler in the battle against drug-resistant pathogens,” Dr. Gottlieb concluded. 

In a panel discussion following the briefing, several experts offered perspective on the FDA’s goals and on the challenges of AMR. 

William Flynn, DVM, deputy director of science policy for the Center of Veterinary Medicine, noted some goals for reducing the use of antibiotics in the veterinary arena. 

“We are trying to focus on the driver: What are the disease conditions that drive use of the product,” he said. Ideally, better management of disease conditions can reduce reliance on antibiotics, he added. 

Also in the panel discussion, Steven Gitterman, MD, deputy director of the division of microbiology devices at the Center for Devices and Radiological Health, emphasized the value of sustainable trial databases so AMR research can continue on an ongoing basis. Finally, Carolyn Wilson, PhD, associate director of research at the Center for Biologics Evaluation and Research, noted that the FDA’s research and development efforts include antibiotic alternatives, including live biotherapeutic products, fecal microbiota transplantation, and bacteriophage therapy.

Visit www.fda.gov for a transcript of Dr. Gottlieb’s talk, and for the updated FDA website page with more details on the agency’s plans to combat antimicrobial resistance. 

Dr. Gottlieb and the panelists had no financial conflicts to disclose.

WASHINGTON – A strategy combining stewardship and science is needed to help combat antimicrobial resistance, and updated plans from the U.S. Food and Drug Administration include four key components to address all aspects of product development and use, FDA commissioner Scott Gottlieb, MD, said in a press briefing in Washington on Sept. 14. 

“The FDA plays a unique role in advancing human and animal health” that provides a unique vantage point for coordinating all aspects of product development and application, he said. 

The FDA’s comprehensive approach to the challenge of antimicrobial resistance (AMR) includes:

• Facilitating product development.
• Promoting antimicrobial stewardship.
• Supporting the development of new tools for surveillance.
• Advancing scientific initiatives, including research for the development of alternative treatments.

The FDA’s product development plan to combat AMR includes the creation of incentives for companies to develop new antibiotic products and create a robust pipeline, which is a challenge because of the lack of immediate economic gain, Dr. Gottlieb said.
“It necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains,” he emphasized. 

Strategies to incentivize companies include fast track designation, priority review, and breakthrough therapy designation. In addition, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) is designed to promote development of antimicrobial drugs for limited and underserved populations, Dr. Gottlieb said. The FDA plan also calls for pursuing reimbursement options with the Centers for Medicare & Medicaid Services. 

Promoting antimicrobial stewardship remains an ongoing element of the FDA’s plan to reduce AMR. In conjunction with the release of the FDA’s updated approach to AMR, the FDA’s Center for Veterinary Medicine CVM released a 5-year action plan to promote and support antimicrobial stewardship in not only the agricultural arena, but in companion animals as well. 

The FDA plans to bring all antimicrobials of medical importance that are approved for use in animals under the oversight of CVM, which will pursue the improve labeling on antimicrobial drugs used in the feed and water of food-producing animals, including defining durations of use, Dr. Gottlieb noted.

Supporting the development and improvement of surveillance tools is “essential to understanding the drivers of resistance in human and veterinary settings and formulating appropriate responses” to outbreaks, Dr. Gottlieb said.

To help meet this goal, the FDA will expand sampling via the National Antimicrobial Resistance Monitoring System (NARMS) database, he said. Other surveillance goals include supporting genomics research and expanding AMR monitoring to include pathogens associated with animal feed and companion animals, he added. 

As part of the final component of the FDA’s AMR strategy to advance scientific initiatives, the FDA has released a new Request for Information “to obtain additional, external input on how best to develop an annual list of regulatory science initiatives specific for antimicrobial products,” Dr. Gottlieb announced. The FDA intends to use the information gained from clinicians and others in its creation of guidance documents and recommendations to streamline the antibiotic development process. He also cited the FDA’s ongoing support of partnerships with public and private organizations such as the Clinical Trials Transformation Initiative, which focuses on drug development for severe bacterial infections with current unmet medical need.

“We need to harness science and policy to help our public health systems and researchers become nimbler in the battle against drug-resistant pathogens,” Dr. Gottlieb concluded. 

In a panel discussion following the briefing, several experts offered perspective on the FDA’s goals and on the challenges of AMR. 

William Flynn, DVM, deputy director of science policy for the Center of Veterinary Medicine, noted some goals for reducing the use of antibiotics in the veterinary arena. 

“We are trying to focus on the driver: What are the disease conditions that drive use of the product,” he said. Ideally, better management of disease conditions can reduce reliance on antibiotics, he added. 

Also in the panel discussion, Steven Gitterman, MD, deputy director of the division of microbiology devices at the Center for Devices and Radiological Health, emphasized the value of sustainable trial databases so AMR research can continue on an ongoing basis. Finally, Carolyn Wilson, PhD, associate director of research at the Center for Biologics Evaluation and Research, noted that the FDA’s research and development efforts include antibiotic alternatives, including live biotherapeutic products, fecal microbiota transplantation, and bacteriophage therapy.

Visit www.fda.gov for a transcript of Dr. Gottlieb’s talk, and for the updated FDA website page with more details on the agency’s plans to combat antimicrobial resistance. 

Dr. Gottlieb and the panelists had no financial conflicts to disclose.

Posttraumatic stress disorder (PTSD) develops after exposure to a traumatic event, which can involve witnessing the traumatic event or directly experiencing the trauma.¹ The prevalence of PTSD in the general population is approximately 7% to 8%.¹ However, not everyone who experiences trauma develops PTSD since the majority of men and women experience at least 1 traumatic event in their lifetimes but do not develop PTSD.¹

In order to be diagnosed with PTSD, a patient must meet several criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).² The patient is required to have exposure to trauma, begin having a certain number of prespecified symptoms, and these symptoms must persist for at least a month.² Symptoms of PTSD include re-experiencing the traumatic event, avoidance of stimuli associated with the trauma, negative cognitions and mood, and hyperarousal.^3,4 The hyperarousal that is associated with PTSD has been theorized to be either a result of the trauma experienced or exacerbation of a pre-existing tendency.⁵ This can manifest in various ways, such as hypervigilance, exaggerated startle response, trouble sleeping, problems concentrating, or irritability.^3,5 These symptoms can cause individuals with PTSD to have elevated levels of stress and to experience difficulties with completing everyday tasks.⁶

PTSD and Inflimmation-Related Medical Conditions

Posttraumatic stress disorder has been linked to various physical health problems. Studies have found that PTSD is often comorbid with cardiovascular, autoimmune, musculoskeletal, digestive, chronic pain and respiratory disorders.^3,7-11 Inflammation may be a contributing factor in the associations between PTSD and these conditions.^12-16 Studies have found that increases in pro-inflammatory cytokines and interferons are associated with PTSD, as well as changes in immune-related blood cells.^12-16

Considering that PTSD has been linked to many medical conditions that have inflammatory components, especially cardiovascular disease, inflammatory markers may be early indicators of PTSD.^12-16 Additionally, inflammatory markers such as cytokines and interferons can be targeted through medications, and potentially influence symptoms.¹³ However, the relation between PTSD and inflammation remains unclear. Associations between PTSD and inflammation-related medical conditions may be due to confounding variables, such as sociodemographic characteristics and health behaviors. Moreover, the list of inflammation-related medical conditions is long and there is no universal agreement of what conditions are related to inflammation.

We recently conducted an epidemiological study using a representative sample of residents living in New York City and found significant associations between PTSD and some inflammation-related medical conditions.⁸ We found that participants who had PTSD were more than 4 times more likely to report having had a heart attack or emphysema than were those without PTSD. In addition, participants with PTSD were 2 times more likely to report having hypercholesterolemia, insulin resistance, and angina than were those without PTSD. However, we also found that participants who had PTSD were less likely to develop other inflammation-related conditions like hypertension, type 1 diabetes mellitus, asthma, coronary heart disease, stroke, osteoporosis, and failing kidney.

Together, these associations suggest there is a strong link between PTSD and certain medical conditions, but the link may not be solely based on inflammation.⁸ Moreover, positive associations between PTSD and hypertension, asthma, and coronary heart disease disappeared when depression was controlled for. This finding points to depression as a major factor, consistent with previous findings that depression is associated with the development of various medical conditions and may be a stronger factor than PTSD.⁸

Nonetheless, findings concerning the increased risk for heart problems among adults with PTSD are striking and important given that heart disease is one of the main causes of death in the United States.⁹ Specifically, well over half a million people in the United States die of heart disease annually as the leading cause of death.¹⁷ Heart disease has been one of the top 2 leading causes of death for Americans since 1975.¹⁸  

In the veteran population, heart disease has also been found to be a leading cause of death, accounting for 20 percent of all deaths in veterans from 1993 to 2002.¹⁹ Posttraumatic stress disorder has been linked to a 55% increase in the chance of developing heart disease or dying from a heart-related medical problem.⁹ For example, data from the World Trade Center Registry showed that on average adults who developed PTSD from the 9/11 terrorist attack had a heightened risk for heart disease for 3 years after the event.⁹ Other studies of the U.S. veteran population have shown that veterans with PTSD are more likely to experience heart failure, myocardial infarction, and cardiac arrhythmia than other veterans.^10,20

Veteran-Specific Issues

In the US veteran population, there is a higher prevalence of PTSD and physical health conditions when compared with the general population.^21,21 The prevalence of combat-related PTSD in veterans ranges from 2% to 17%, compared with a 7% to 8% prevalence of PTSD in the general population.^1,22 In a study of veterans who were seen in patient-aligned care teams (PACTs) > 1 year, 9.3% were diagnosed with PTSD and many of those with PTSD also had other medical conditions.²¹ It was found that 43% of veterans seen by PACTs with chronic pain had PTSD, 33% with hypertension had PTSD, and 32% with diabetes mellitus had PTSD.²¹ In another study of combat veterans it was found that those who were trauma-exposed had more physical health problems, regardless of the amount of time spent in combat.¹⁹ Consequentially, veterans with PTSD have been found to make more frequent visits to primary care and specialty medical care clinics. ²¹

Integrated healthcare has been a main service model for the Department of Veteran Affairs (VA) and several programs have been created to integrate mental health and primary care. For example, the VA primary care-mental health integration (PCMHI) program places mental health services within primary care services.²¹ Assessments of this program have demonstrated that it improves the screening of psychological disorders and preventive care of patients who have psychological disorders.²¹ Specifically, it has been found that contact with PCMHI diminishes risks for poor outcomes among psychiatric patients.²¹ Another program called SCAN-ECHO, provides specialized training for VA general practitioners on treating specific health conditions through a specialty care team and video conferencing.²³ This VA program allows for patients in more remote locations to receive specialty care from generalists.²³ While there has not yet been a focus in SCAN-ECHO on PTSD, this may be considered in the future as a way to better train primary care and mental health providers about PTSD and common comorbid medical conditions.

Through their professional experiences, VA practitioners have knowledge of the link between PTSD and various medical conditions. The VA has already implemented screening for PTSD in primary care clinics, but it is important for mental health providers and medical practitioners to continue educating themselves about medical comorbidities and the possible exacerbation of medical conditions due to PTSD.²¹ Some physical manifestations of PTSD symptoms, such as sleep disturbances, avoidance of crowds, or hypervigilance, can affect overall health. Hypervigilance can result in over-activation of stress pathways, which puts patients with PTSD at a heighted risk for medical conditions.¹¹ Additionally, some of the cognitive symptoms of PTSD, such as sleep problems, may worsen current health problems. Therefore, further collaboration between primary care physicians and mental health providers is beneficial in treating clients that have PTSD.

Conclusion

Posttraumatic stress disorder is a prevalent condition among veterans that is often comorbid with other medical conditions, which may have important implications for VA healthcare teams.³ It can manifest both psychologically and physiologically, and can greatly affect a patient’s quality of life.³ Veterans with PTSD may be at increased risk for certain medical conditions, such as cardiovascular disease.^9,10,20  However, preventive screenings for medical conditions linked to PTSD and regular health assessments may reduce these risks.²¹ The VA’s infrastructure of integrated medical and mental healthcare can help provide comprehensive care to the many veterans who have both PTSD and serious medical conditions.²¹ While the relation between PTSD and inflammation remains unclear, it is clear that many people with PTSD have medical conditions that may be affected by PTSD symptoms.

Posttraumatic stress disorder (PTSD) develops after exposure to a traumatic event, which can involve witnessing the traumatic event or directly experiencing the trauma.¹ The prevalence of PTSD in the general population is approximately 7% to 8%.¹ However, not everyone who experiences trauma develops PTSD since the majority of men and women experience at least 1 traumatic event in their lifetimes but do not develop PTSD.¹

In order to be diagnosed with PTSD, a patient must meet several criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).² The patient is required to have exposure to trauma, begin having a certain number of prespecified symptoms, and these symptoms must persist for at least a month.² Symptoms of PTSD include re-experiencing the traumatic event, avoidance of stimuli associated with the trauma, negative cognitions and mood, and hyperarousal.^3,4 The hyperarousal that is associated with PTSD has been theorized to be either a result of the trauma experienced or exacerbation of a pre-existing tendency.⁵ This can manifest in various ways, such as hypervigilance, exaggerated startle response, trouble sleeping, problems concentrating, or irritability.^3,5 These symptoms can cause individuals with PTSD to have elevated levels of stress and to experience difficulties with completing everyday tasks.⁶

PTSD and Inflimmation-Related Medical Conditions

Posttraumatic stress disorder has been linked to various physical health problems. Studies have found that PTSD is often comorbid with cardiovascular, autoimmune, musculoskeletal, digestive, chronic pain and respiratory disorders.^3,7-11 Inflammation may be a contributing factor in the associations between PTSD and these conditions.^12-16 Studies have found that increases in pro-inflammatory cytokines and interferons are associated with PTSD, as well as changes in immune-related blood cells.^12-16

Considering that PTSD has been linked to many medical conditions that have inflammatory components, especially cardiovascular disease, inflammatory markers may be early indicators of PTSD.^12-16 Additionally, inflammatory markers such as cytokines and interferons can be targeted through medications, and potentially influence symptoms.¹³ However, the relation between PTSD and inflammation remains unclear. Associations between PTSD and inflammation-related medical conditions may be due to confounding variables, such as sociodemographic characteristics and health behaviors. Moreover, the list of inflammation-related medical conditions is long and there is no universal agreement of what conditions are related to inflammation.

We recently conducted an epidemiological study using a representative sample of residents living in New York City and found significant associations between PTSD and some inflammation-related medical conditions.⁸ We found that participants who had PTSD were more than 4 times more likely to report having had a heart attack or emphysema than were those without PTSD. In addition, participants with PTSD were 2 times more likely to report having hypercholesterolemia, insulin resistance, and angina than were those without PTSD. However, we also found that participants who had PTSD were less likely to develop other inflammation-related conditions like hypertension, type 1 diabetes mellitus, asthma, coronary heart disease, stroke, osteoporosis, and failing kidney.

Together, these associations suggest there is a strong link between PTSD and certain medical conditions, but the link may not be solely based on inflammation.⁸ Moreover, positive associations between PTSD and hypertension, asthma, and coronary heart disease disappeared when depression was controlled for. This finding points to depression as a major factor, consistent with previous findings that depression is associated with the development of various medical conditions and may be a stronger factor than PTSD.⁸

Nonetheless, findings concerning the increased risk for heart problems among adults with PTSD are striking and important given that heart disease is one of the main causes of death in the United States.⁹ Specifically, well over half a million people in the United States die of heart disease annually as the leading cause of death.¹⁷ Heart disease has been one of the top 2 leading causes of death for Americans since 1975.¹⁸  

In the veteran population, heart disease has also been found to be a leading cause of death, accounting for 20 percent of all deaths in veterans from 1993 to 2002.¹⁹ Posttraumatic stress disorder has been linked to a 55% increase in the chance of developing heart disease or dying from a heart-related medical problem.⁹ For example, data from the World Trade Center Registry showed that on average adults who developed PTSD from the 9/11 terrorist attack had a heightened risk for heart disease for 3 years after the event.⁹ Other studies of the U.S. veteran population have shown that veterans with PTSD are more likely to experience heart failure, myocardial infarction, and cardiac arrhythmia than other veterans.^10,20

Veteran-Specific Issues

In the US veteran population, there is a higher prevalence of PTSD and physical health conditions when compared with the general population.^21,21 The prevalence of combat-related PTSD in veterans ranges from 2% to 17%, compared with a 7% to 8% prevalence of PTSD in the general population.^1,22 In a study of veterans who were seen in patient-aligned care teams (PACTs) > 1 year, 9.3% were diagnosed with PTSD and many of those with PTSD also had other medical conditions.²¹ It was found that 43% of veterans seen by PACTs with chronic pain had PTSD, 33% with hypertension had PTSD, and 32% with diabetes mellitus had PTSD.²¹ In another study of combat veterans it was found that those who were trauma-exposed had more physical health problems, regardless of the amount of time spent in combat.¹⁹ Consequentially, veterans with PTSD have been found to make more frequent visits to primary care and specialty medical care clinics. ²¹

Integrated healthcare has been a main service model for the Department of Veteran Affairs (VA) and several programs have been created to integrate mental health and primary care. For example, the VA primary care-mental health integration (PCMHI) program places mental health services within primary care services.²¹ Assessments of this program have demonstrated that it improves the screening of psychological disorders and preventive care of patients who have psychological disorders.²¹ Specifically, it has been found that contact with PCMHI diminishes risks for poor outcomes among psychiatric patients.²¹ Another program called SCAN-ECHO, provides specialized training for VA general practitioners on treating specific health conditions through a specialty care team and video conferencing.²³ This VA program allows for patients in more remote locations to receive specialty care from generalists.²³ While there has not yet been a focus in SCAN-ECHO on PTSD, this may be considered in the future as a way to better train primary care and mental health providers about PTSD and common comorbid medical conditions.

Through their professional experiences, VA practitioners have knowledge of the link between PTSD and various medical conditions. The VA has already implemented screening for PTSD in primary care clinics, but it is important for mental health providers and medical practitioners to continue educating themselves about medical comorbidities and the possible exacerbation of medical conditions due to PTSD.²¹ Some physical manifestations of PTSD symptoms, such as sleep disturbances, avoidance of crowds, or hypervigilance, can affect overall health. Hypervigilance can result in over-activation of stress pathways, which puts patients with PTSD at a heighted risk for medical conditions.¹¹ Additionally, some of the cognitive symptoms of PTSD, such as sleep problems, may worsen current health problems. Therefore, further collaboration between primary care physicians and mental health providers is beneficial in treating clients that have PTSD.

Conclusion

Posttraumatic stress disorder is a prevalent condition among veterans that is often comorbid with other medical conditions, which may have important implications for VA healthcare teams.³ It can manifest both psychologically and physiologically, and can greatly affect a patient’s quality of life.³ Veterans with PTSD may be at increased risk for certain medical conditions, such as cardiovascular disease.^9,10,20  However, preventive screenings for medical conditions linked to PTSD and regular health assessments may reduce these risks.²¹ The VA’s infrastructure of integrated medical and mental healthcare can help provide comprehensive care to the many veterans who have both PTSD and serious medical conditions.²¹ While the relation between PTSD and inflammation remains unclear, it is clear that many people with PTSD have medical conditions that may be affected by PTSD symptoms.

Posttraumatic stress disorder (PTSD) develops after exposure to a traumatic event, which can involve witnessing the traumatic event or directly experiencing the trauma.¹ The prevalence of PTSD in the general population is approximately 7% to 8%.¹ However, not everyone who experiences trauma develops PTSD since the majority of men and women experience at least 1 traumatic event in their lifetimes but do not develop PTSD.¹

In order to be diagnosed with PTSD, a patient must meet several criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).² The patient is required to have exposure to trauma, begin having a certain number of prespecified symptoms, and these symptoms must persist for at least a month.² Symptoms of PTSD include re-experiencing the traumatic event, avoidance of stimuli associated with the trauma, negative cognitions and mood, and hyperarousal.^3,4 The hyperarousal that is associated with PTSD has been theorized to be either a result of the trauma experienced or exacerbation of a pre-existing tendency.⁵ This can manifest in various ways, such as hypervigilance, exaggerated startle response, trouble sleeping, problems concentrating, or irritability.^3,5 These symptoms can cause individuals with PTSD to have elevated levels of stress and to experience difficulties with completing everyday tasks.⁶

PTSD and Inflimmation-Related Medical Conditions

Posttraumatic stress disorder has been linked to various physical health problems. Studies have found that PTSD is often comorbid with cardiovascular, autoimmune, musculoskeletal, digestive, chronic pain and respiratory disorders.^3,7-11 Inflammation may be a contributing factor in the associations between PTSD and these conditions.^12-16 Studies have found that increases in pro-inflammatory cytokines and interferons are associated with PTSD, as well as changes in immune-related blood cells.^12-16

Considering that PTSD has been linked to many medical conditions that have inflammatory components, especially cardiovascular disease, inflammatory markers may be early indicators of PTSD.^12-16 Additionally, inflammatory markers such as cytokines and interferons can be targeted through medications, and potentially influence symptoms.¹³ However, the relation between PTSD and inflammation remains unclear. Associations between PTSD and inflammation-related medical conditions may be due to confounding variables, such as sociodemographic characteristics and health behaviors. Moreover, the list of inflammation-related medical conditions is long and there is no universal agreement of what conditions are related to inflammation.

We recently conducted an epidemiological study using a representative sample of residents living in New York City and found significant associations between PTSD and some inflammation-related medical conditions.⁸ We found that participants who had PTSD were more than 4 times more likely to report having had a heart attack or emphysema than were those without PTSD. In addition, participants with PTSD were 2 times more likely to report having hypercholesterolemia, insulin resistance, and angina than were those without PTSD. However, we also found that participants who had PTSD were less likely to develop other inflammation-related conditions like hypertension, type 1 diabetes mellitus, asthma, coronary heart disease, stroke, osteoporosis, and failing kidney.

Together, these associations suggest there is a strong link between PTSD and certain medical conditions, but the link may not be solely based on inflammation.⁸ Moreover, positive associations between PTSD and hypertension, asthma, and coronary heart disease disappeared when depression was controlled for. This finding points to depression as a major factor, consistent with previous findings that depression is associated with the development of various medical conditions and may be a stronger factor than PTSD.⁸

Nonetheless, findings concerning the increased risk for heart problems among adults with PTSD are striking and important given that heart disease is one of the main causes of death in the United States.⁹ Specifically, well over half a million people in the United States die of heart disease annually as the leading cause of death.¹⁷ Heart disease has been one of the top 2 leading causes of death for Americans since 1975.¹⁸  

In the veteran population, heart disease has also been found to be a leading cause of death, accounting for 20 percent of all deaths in veterans from 1993 to 2002.¹⁹ Posttraumatic stress disorder has been linked to a 55% increase in the chance of developing heart disease or dying from a heart-related medical problem.⁹ For example, data from the World Trade Center Registry showed that on average adults who developed PTSD from the 9/11 terrorist attack had a heightened risk for heart disease for 3 years after the event.⁹ Other studies of the U.S. veteran population have shown that veterans with PTSD are more likely to experience heart failure, myocardial infarction, and cardiac arrhythmia than other veterans.^10,20

Veteran-Specific Issues

In the US veteran population, there is a higher prevalence of PTSD and physical health conditions when compared with the general population.^21,21 The prevalence of combat-related PTSD in veterans ranges from 2% to 17%, compared with a 7% to 8% prevalence of PTSD in the general population.^1,22 In a study of veterans who were seen in patient-aligned care teams (PACTs) > 1 year, 9.3% were diagnosed with PTSD and many of those with PTSD also had other medical conditions.²¹ It was found that 43% of veterans seen by PACTs with chronic pain had PTSD, 33% with hypertension had PTSD, and 32% with diabetes mellitus had PTSD.²¹ In another study of combat veterans it was found that those who were trauma-exposed had more physical health problems, regardless of the amount of time spent in combat.¹⁹ Consequentially, veterans with PTSD have been found to make more frequent visits to primary care and specialty medical care clinics. ²¹

Integrated healthcare has been a main service model for the Department of Veteran Affairs (VA) and several programs have been created to integrate mental health and primary care. For example, the VA primary care-mental health integration (PCMHI) program places mental health services within primary care services.²¹ Assessments of this program have demonstrated that it improves the screening of psychological disorders and preventive care of patients who have psychological disorders.²¹ Specifically, it has been found that contact with PCMHI diminishes risks for poor outcomes among psychiatric patients.²¹ Another program called SCAN-ECHO, provides specialized training for VA general practitioners on treating specific health conditions through a specialty care team and video conferencing.²³ This VA program allows for patients in more remote locations to receive specialty care from generalists.²³ While there has not yet been a focus in SCAN-ECHO on PTSD, this may be considered in the future as a way to better train primary care and mental health providers about PTSD and common comorbid medical conditions.

Through their professional experiences, VA practitioners have knowledge of the link between PTSD and various medical conditions. The VA has already implemented screening for PTSD in primary care clinics, but it is important for mental health providers and medical practitioners to continue educating themselves about medical comorbidities and the possible exacerbation of medical conditions due to PTSD.²¹ Some physical manifestations of PTSD symptoms, such as sleep disturbances, avoidance of crowds, or hypervigilance, can affect overall health. Hypervigilance can result in over-activation of stress pathways, which puts patients with PTSD at a heighted risk for medical conditions.¹¹ Additionally, some of the cognitive symptoms of PTSD, such as sleep problems, may worsen current health problems. Therefore, further collaboration between primary care physicians and mental health providers is beneficial in treating clients that have PTSD.

Conclusion

Posttraumatic stress disorder is a prevalent condition among veterans that is often comorbid with other medical conditions, which may have important implications for VA healthcare teams.³ It can manifest both psychologically and physiologically, and can greatly affect a patient’s quality of life.³ Veterans with PTSD may be at increased risk for certain medical conditions, such as cardiovascular disease.^9,10,20  However, preventive screenings for medical conditions linked to PTSD and regular health assessments may reduce these risks.²¹ The VA’s infrastructure of integrated medical and mental healthcare can help provide comprehensive care to the many veterans who have both PTSD and serious medical conditions.²¹ While the relation between PTSD and inflammation remains unclear, it is clear that many people with PTSD have medical conditions that may be affected by PTSD symptoms.

The use of tyrosine kinase inhibitors (TKIs) sunitinib and pazopanib to treat metastatic clear cell renal cell carcinoma (RCC) is feasible and effective in Brazil, even though limitations of the public health system mean not all patients have access to these or other therapies, researchers wrote.

In a retrospective analysis of 222 patients with advanced clear cell RCC who were treated with either sunitinib (n = 109) or pazopanib (n = 113), overall survival was 15.2 months with sunitinib and 14.2 months with pazopanib, investigators reported in the Journal of Global Oncology.

Overall survival rates, based on Memorial Sloan Kettering Cancer Center risk categories, were 32.9 months for patients with low risk disease, 15.9 months for intermediate risk patients, and 8.1 months for patient with poor risk – which constituted 29% of the patient population.

Pedro I. Velho, MD, of Johns Hopkins University, Baltimore, and his coauthors noted that these survival rates were lower than those seen in phase 3 trials in the same population.

They suggested this could be caused by the fact that the patients in this real-world study had worse baseline prognoses than those seen in previous clinical trials.

However, they also pointed out that, in the Brazilian public health system, there was no standard systemic treatment option outside clinical trials for patients who have progressed on a TKI as a first-line treatment. Only around half the patients in this study (101) would have been eligible for participation in a clinical trial.

“In our opinion, it is crucial to extend the access to these TKIs for the Brazilian population and also patients in other countries with limited access to targeted therapies,” the authors wrote.

However, the 14 patients who were eligible for treatment with nivolumab under a compassionate use program showed a significantly better overall survival rate, compared with patients who did not have access to a second-line therapy (36.7 months vs. 13.6 months; P less than .001).

“Also, it is imperative to provide systemic sequential treatment options for this population as an attempt to improve survival and offer the best outcomes for patients with metastatic RCC.”

The median duration of treatment with sunitinib was 6.4 months, and with pazopanib, it was 6.7 months. Adverse events were responsible for discontinuation of treatment in 28.4% of patients on sunitinib and 22.1% of patients on pazopanib, with fatigue, diarrhea, nausea and vomiting as the most common toxicities in both groups.

Six authors declared honoraria, funding, expenses or consultancies with the pharmaceutical industry. Two authors had no conflicts of interest to declare.

SOURCE: Velho PI et al. J Glob Oncol. 2018 Sep 10. doi: 10.1200/JGO.18.00073.

The use of tyrosine kinase inhibitors (TKIs) sunitinib and pazopanib to treat metastatic clear cell renal cell carcinoma (RCC) is feasible and effective in Brazil, even though limitations of the public health system mean not all patients have access to these or other therapies, researchers wrote.

In a retrospective analysis of 222 patients with advanced clear cell RCC who were treated with either sunitinib (n = 109) or pazopanib (n = 113), overall survival was 15.2 months with sunitinib and 14.2 months with pazopanib, investigators reported in the Journal of Global Oncology.

Overall survival rates, based on Memorial Sloan Kettering Cancer Center risk categories, were 32.9 months for patients with low risk disease, 15.9 months for intermediate risk patients, and 8.1 months for patient with poor risk – which constituted 29% of the patient population.

Pedro I. Velho, MD, of Johns Hopkins University, Baltimore, and his coauthors noted that these survival rates were lower than those seen in phase 3 trials in the same population.

They suggested this could be caused by the fact that the patients in this real-world study had worse baseline prognoses than those seen in previous clinical trials.

However, they also pointed out that, in the Brazilian public health system, there was no standard systemic treatment option outside clinical trials for patients who have progressed on a TKI as a first-line treatment. Only around half the patients in this study (101) would have been eligible for participation in a clinical trial.

“In our opinion, it is crucial to extend the access to these TKIs for the Brazilian population and also patients in other countries with limited access to targeted therapies,” the authors wrote.

However, the 14 patients who were eligible for treatment with nivolumab under a compassionate use program showed a significantly better overall survival rate, compared with patients who did not have access to a second-line therapy (36.7 months vs. 13.6 months; P less than .001).

“Also, it is imperative to provide systemic sequential treatment options for this population as an attempt to improve survival and offer the best outcomes for patients with metastatic RCC.”

The median duration of treatment with sunitinib was 6.4 months, and with pazopanib, it was 6.7 months. Adverse events were responsible for discontinuation of treatment in 28.4% of patients on sunitinib and 22.1% of patients on pazopanib, with fatigue, diarrhea, nausea and vomiting as the most common toxicities in both groups.

Six authors declared honoraria, funding, expenses or consultancies with the pharmaceutical industry. Two authors had no conflicts of interest to declare.

SOURCE: Velho PI et al. J Glob Oncol. 2018 Sep 10. doi: 10.1200/JGO.18.00073.

The use of tyrosine kinase inhibitors (TKIs) sunitinib and pazopanib to treat metastatic clear cell renal cell carcinoma (RCC) is feasible and effective in Brazil, even though limitations of the public health system mean not all patients have access to these or other therapies, researchers wrote.

In a retrospective analysis of 222 patients with advanced clear cell RCC who were treated with either sunitinib (n = 109) or pazopanib (n = 113), overall survival was 15.2 months with sunitinib and 14.2 months with pazopanib, investigators reported in the Journal of Global Oncology.

Overall survival rates, based on Memorial Sloan Kettering Cancer Center risk categories, were 32.9 months for patients with low risk disease, 15.9 months for intermediate risk patients, and 8.1 months for patient with poor risk – which constituted 29% of the patient population.

Pedro I. Velho, MD, of Johns Hopkins University, Baltimore, and his coauthors noted that these survival rates were lower than those seen in phase 3 trials in the same population.

They suggested this could be caused by the fact that the patients in this real-world study had worse baseline prognoses than those seen in previous clinical trials.

However, they also pointed out that, in the Brazilian public health system, there was no standard systemic treatment option outside clinical trials for patients who have progressed on a TKI as a first-line treatment. Only around half the patients in this study (101) would have been eligible for participation in a clinical trial.

“In our opinion, it is crucial to extend the access to these TKIs for the Brazilian population and also patients in other countries with limited access to targeted therapies,” the authors wrote.

However, the 14 patients who were eligible for treatment with nivolumab under a compassionate use program showed a significantly better overall survival rate, compared with patients who did not have access to a second-line therapy (36.7 months vs. 13.6 months; P less than .001).

“Also, it is imperative to provide systemic sequential treatment options for this population as an attempt to improve survival and offer the best outcomes for patients with metastatic RCC.”

The median duration of treatment with sunitinib was 6.4 months, and with pazopanib, it was 6.7 months. Adverse events were responsible for discontinuation of treatment in 28.4% of patients on sunitinib and 22.1% of patients on pazopanib, with fatigue, diarrhea, nausea and vomiting as the most common toxicities in both groups.

Six authors declared honoraria, funding, expenses or consultancies with the pharmaceutical industry. Two authors had no conflicts of interest to declare.

SOURCE: Velho PI et al. J Glob Oncol. 2018 Sep 10. doi: 10.1200/JGO.18.00073.

The combination of a targeted antiangiogenic agent and denosumab (Xgeva) appears to significantly increase the risk for osteonecrosis of the jaw in patients with metastatic renal cell carcinoma (mRCC), French investigators cautioned.

Among 41 patients with RCC metastatic to bone treated with an antiangiogenic agent and denosumab, 7 (17%) developed osteonecrosis of the jaw (ONJ). All seven received the combination in the first line, reported Aline Guillot, MD, from the Institut de cancérologie Lucien Neuwirth in Saint-Priest-en-Jarez, France, and her colleagues.

“The incidence of ONJ was high in this real-life population of patients with mRCC treated with antiangiogenic therapies combined with denosumab. This toxicity signal should warn physicians about this combination in the mRCC population,” they wrote in Clinical Genitourinary Cancer.

Previous studies have shown that the combination of another bone-targeted therapy – zoledronic acid – with antiangiogenic tyrosine kinase inhibitors (TKIs) such as sunitinib (Sutent) is associated with increased risk for ONJ. In addition, ONJ with the combination of denosumab and antiangiogenic therapies “has been noticed but never estimated,” the authors noted.

To evaluate the incidence of hypocalcemia and ONJ in patients with RCC metastatic to bone treated with denosumab and a TKI or mammalian target of rapamycin inhibitor, the investigators gathered data retrospectively from 10 French centers.

They identified 25 men and 16 women with a median age of 62 years (range, 54-68 years). Of this group, 40 received denosumab in the first line in combination with either sunitinib (31 patients), pazopanib (6), everolimus (Afinitor and generics; 2), and temsirolimus (Torisel and generics; 1). The median duration of first-line therapy was 12 months.

Denosumab was given in the second line with axitinib (Inlyta) to nine patients, with everolimus to nine, and with sunitinib to three patients. The median duration of second-line therapy was 3 months.

Skeletal-related events occurred in 41% of patients prior to receiving denosumab and in 61% (25 patients) after denosumab. The events included clinical fracture, bone pain requiring radiation, and spinal compression.

Of the seven patients who developed ONJ, six received denosumab and sunitinib in the first line and one received denosumab plus temsirolimus, with a median duration of treatment of 11.8 months. Three of these patients also received denosumab in the second line with either axitinib, everolimus, or sunitinib, with a median duration of 9.8 months. Data on second-line therapy for the remaining four patients with ONJ were not available.

The investigators noted that the 17% incidence of ONJ was higher than the 10% rate seen in a study of patients with mRCC treated with a TKI and a bisphosphonate (Acta Clin Belg. 2018 Apr;73(2):100-9), and the 1.8% incidence seen in an analysis of three phase 3 trials in cancer patients with bone metastases (Ann Oncol. 2012 May;23(5):1341-7).

Although the etiology of ONJ is unknown, patient education and oral hygiene may reduce the risk in patients treated with denosumab and a TKI.

“The benefit of denosumab in this setting in regard [to] toxicity needs to be demonstrated in a prospective trial,” they wrote.

No conflicts of interest or disclosures were reported.

SOURCE: Guillot A et al. Clin Genitourin Cancer. 2018 Sep 6. doi: 10.1016/j.clgc.2018.08.006.

The combination of a targeted antiangiogenic agent and denosumab (Xgeva) appears to significantly increase the risk for osteonecrosis of the jaw in patients with metastatic renal cell carcinoma (mRCC), French investigators cautioned.

Among 41 patients with RCC metastatic to bone treated with an antiangiogenic agent and denosumab, 7 (17%) developed osteonecrosis of the jaw (ONJ). All seven received the combination in the first line, reported Aline Guillot, MD, from the Institut de cancérologie Lucien Neuwirth in Saint-Priest-en-Jarez, France, and her colleagues.

“The incidence of ONJ was high in this real-life population of patients with mRCC treated with antiangiogenic therapies combined with denosumab. This toxicity signal should warn physicians about this combination in the mRCC population,” they wrote in Clinical Genitourinary Cancer.

Previous studies have shown that the combination of another bone-targeted therapy – zoledronic acid – with antiangiogenic tyrosine kinase inhibitors (TKIs) such as sunitinib (Sutent) is associated with increased risk for ONJ. In addition, ONJ with the combination of denosumab and antiangiogenic therapies “has been noticed but never estimated,” the authors noted.

To evaluate the incidence of hypocalcemia and ONJ in patients with RCC metastatic to bone treated with denosumab and a TKI or mammalian target of rapamycin inhibitor, the investigators gathered data retrospectively from 10 French centers.

They identified 25 men and 16 women with a median age of 62 years (range, 54-68 years). Of this group, 40 received denosumab in the first line in combination with either sunitinib (31 patients), pazopanib (6), everolimus (Afinitor and generics; 2), and temsirolimus (Torisel and generics; 1). The median duration of first-line therapy was 12 months.

Denosumab was given in the second line with axitinib (Inlyta) to nine patients, with everolimus to nine, and with sunitinib to three patients. The median duration of second-line therapy was 3 months.

Skeletal-related events occurred in 41% of patients prior to receiving denosumab and in 61% (25 patients) after denosumab. The events included clinical fracture, bone pain requiring radiation, and spinal compression.

Of the seven patients who developed ONJ, six received denosumab and sunitinib in the first line and one received denosumab plus temsirolimus, with a median duration of treatment of 11.8 months. Three of these patients also received denosumab in the second line with either axitinib, everolimus, or sunitinib, with a median duration of 9.8 months. Data on second-line therapy for the remaining four patients with ONJ were not available.

The investigators noted that the 17% incidence of ONJ was higher than the 10% rate seen in a study of patients with mRCC treated with a TKI and a bisphosphonate (Acta Clin Belg. 2018 Apr;73(2):100-9), and the 1.8% incidence seen in an analysis of three phase 3 trials in cancer patients with bone metastases (Ann Oncol. 2012 May;23(5):1341-7).

Although the etiology of ONJ is unknown, patient education and oral hygiene may reduce the risk in patients treated with denosumab and a TKI.

“The benefit of denosumab in this setting in regard [to] toxicity needs to be demonstrated in a prospective trial,” they wrote.

No conflicts of interest or disclosures were reported.

SOURCE: Guillot A et al. Clin Genitourin Cancer. 2018 Sep 6. doi: 10.1016/j.clgc.2018.08.006.

The combination of a targeted antiangiogenic agent and denosumab (Xgeva) appears to significantly increase the risk for osteonecrosis of the jaw in patients with metastatic renal cell carcinoma (mRCC), French investigators cautioned.

Among 41 patients with RCC metastatic to bone treated with an antiangiogenic agent and denosumab, 7 (17%) developed osteonecrosis of the jaw (ONJ). All seven received the combination in the first line, reported Aline Guillot, MD, from the Institut de cancérologie Lucien Neuwirth in Saint-Priest-en-Jarez, France, and her colleagues.

“The incidence of ONJ was high in this real-life population of patients with mRCC treated with antiangiogenic therapies combined with denosumab. This toxicity signal should warn physicians about this combination in the mRCC population,” they wrote in Clinical Genitourinary Cancer.

Previous studies have shown that the combination of another bone-targeted therapy – zoledronic acid – with antiangiogenic tyrosine kinase inhibitors (TKIs) such as sunitinib (Sutent) is associated with increased risk for ONJ. In addition, ONJ with the combination of denosumab and antiangiogenic therapies “has been noticed but never estimated,” the authors noted.

To evaluate the incidence of hypocalcemia and ONJ in patients with RCC metastatic to bone treated with denosumab and a TKI or mammalian target of rapamycin inhibitor, the investigators gathered data retrospectively from 10 French centers.

They identified 25 men and 16 women with a median age of 62 years (range, 54-68 years). Of this group, 40 received denosumab in the first line in combination with either sunitinib (31 patients), pazopanib (6), everolimus (Afinitor and generics; 2), and temsirolimus (Torisel and generics; 1). The median duration of first-line therapy was 12 months.

Denosumab was given in the second line with axitinib (Inlyta) to nine patients, with everolimus to nine, and with sunitinib to three patients. The median duration of second-line therapy was 3 months.

Skeletal-related events occurred in 41% of patients prior to receiving denosumab and in 61% (25 patients) after denosumab. The events included clinical fracture, bone pain requiring radiation, and spinal compression.

Of the seven patients who developed ONJ, six received denosumab and sunitinib in the first line and one received denosumab plus temsirolimus, with a median duration of treatment of 11.8 months. Three of these patients also received denosumab in the second line with either axitinib, everolimus, or sunitinib, with a median duration of 9.8 months. Data on second-line therapy for the remaining four patients with ONJ were not available.

The investigators noted that the 17% incidence of ONJ was higher than the 10% rate seen in a study of patients with mRCC treated with a TKI and a bisphosphonate (Acta Clin Belg. 2018 Apr;73(2):100-9), and the 1.8% incidence seen in an analysis of three phase 3 trials in cancer patients with bone metastases (Ann Oncol. 2012 May;23(5):1341-7).

Although the etiology of ONJ is unknown, patient education and oral hygiene may reduce the risk in patients treated with denosumab and a TKI.

“The benefit of denosumab in this setting in regard [to] toxicity needs to be demonstrated in a prospective trial,” they wrote.

No conflicts of interest or disclosures were reported.

SOURCE: Guillot A et al. Clin Genitourin Cancer. 2018 Sep 6. doi: 10.1016/j.clgc.2018.08.006.

Nurse practitioners (NPs) and physician assistants (PAs) have become a more prominent part of the hospitalist workforce, and at many institutions, they account for a large proportion of patient care and have a powerful effect on a patient’s experience. But NP and PA roles in hospital medicine continue to evolve – and understanding what they do is still, at times, a work in progress.

One myth that persists regarding NPs and PAs is that, if you’ve seen one, you’ve seen them all.

At the 2018 Annual Conference of the Society of Hospital Medicine, Noam Shabani, MS, PA-C, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit, Boston, offered an example to help shatter this misperception.

Mr. Shabani described a 28-year-old woman who had a bachelor’s in biology with a premed track and spent 4 years as a paramedic before attending the physician assistant program at Duke University, Durham, N.C. As a new PA graduate, she was hired as a hospitalist at a community hospital in Kentucky.

Given this new PA’s clinical experience and formal education, there are certain skills she should bring to the table: the ability to develop a differential diagnosis and a good understanding of disease pathophysiology and the mechanisms of action of drugs. And because of her paramedic experience, she should be comfortable with making urgent clinical care decisions and should be proficient with electrocardiograms, as well as chest and abdominal x-rays.

But compared with a newly graduated NP with registered nurse (RN) floor experience, the PA is likely to be less familiar with hospital mechanics and systems, with leading goal of care discussions with patients and families, and with understanding nuances involved with transitions of care.

The subtle differences between NPs and PAs don’t end there. Because of the progressive policies and recently updated bylaws at the Kentucky hospital where the PA was hired, this health care professional can see patients and write notes independently without a physician signature. But because she practices in Kentucky, she is not allowed to prescribe Schedule II medications, per state law.

“This example demonstrates how nuanced and multi-layered the process of integrating NPs and PAs into hospitalist groups can be,” Mr. Shabani said.
 

Goals, roles, and expectations

Physician assistants and nurse practitioners have reported that their job descriptions, and the variety of roles they can play within HM teams, are becoming better understood by hospitalist physicians and administrators. However, they also have acknowledged that both PAs and NPs are still underutilized.

Tricia Marriott, PA-C, MPAS, an orthopedic service line administrator at Saint Mary’s Hospital in Waterbury, Conn., and an expert in NP and PA policy, has noticed growing enlightenment about PAs and NPs in her travels to conferences in recent years.

“I’m no longer explaining what a PA is and what an NP is, and the questions have become very sophisticated,” she said at HM18. “However, I spent the last two days in the exhibit hall, and some of the conversations I had with physicians are interesting in that the practice and utilization styles have not become sophisticated. So I think there is a lot of opportunity out there.”

Mr. Shabani said the hospitalist care provided by PAs and NPs sits “at the intersection” of state regulations, hospital bylaws, department utilization, and – of course – clinical experience and formal medical education.

“What this boils down to is first understanding these factors, followed by strategizing recruitment and training as a response,” he said.

Tracy Cardin, ACNP-BC, SFHM, associate director of clinical integration at Adfinitas Health in Hanover, Md., and a Society of Hospital Medicine board member, said that, even though she usually sees and hears about a 10%-15% productivity gap between physicians and PAs or NPs, there is no good reason that an experienced PA or NP should not be able to handle the same patient load as a physician hospitalist – if that’s the goal.

“Part of it is about communication of expectation,” she said, noting that organizations must provide the training to allows NPs and PAs to reach prescribed goals along with an adequate level of administrative support. “I think we shouldn’t accept those gaps in productivity.”

Nicolas Houghton, DNP, ACNP-BC, CFRN, nurse practitioner/physician assistant manager at the Cleveland Clinic, thinks that it is completely reasonable for health care organizations to have an expectation that, at the 3- to 5-year mark, NPs and PAs “are really going to be functioning at very high levels that may be nearly indistinguishable.”

Dr. Houghton and Mr. Shabani agreed that, while they had considerably different duties at the start of their careers, they now have clinical roles which mirror one another.

For example, they agreed on these basics: NPs must be a certified RN, while a PA can have any undergraduate degree with certain prerequisite courses such as biology and chemistry. All PAs are trained in general medicine, while NPs specialize in areas such as acute care, family medicine, geriatrics, and women’s health. NPs need 500 didactic hours and 500-700 clinical hours in their area of expertise, while physician assistants need 1,000 didactic and 2,000 clinical hours spread over many disciplines.

For NP’s, required clinical rotations depend on the specialty, while all PAs need to complete rotations in inpatient medicine, emergency medicine, primary care, surgery, psychiatry, pediatrics, and ob.gyn. Also, NPs can practice independently in 23 states and the District of Columbia, while PAs must have a supervising physician. About 10% of NPs work in hospital settings, and about 39% of PAs work in hospital settings, they said.

Dr. Houghton and Mr. Shabani emphasized that Medicare does recognize NP and PA services as physician services. The official language, in place since 1998, is that their services “are the type that are considered physician’s services if furnished by a doctor of medicine or osteopathy.”

Mr. Shabani said this remained a very relevant issue. “I can’t overstate how important this is,” he said.
 

Debunking myths

Several myths continue to persist about PAs and NPs, Ms. Marriott said. Some administrators and physicians believe that they can’t see new patients, that a physician must see every patient, that a physician cosignature means that a claim can be submitted under the physician’s name, that reimbursement for services provided by PAs and NPs “leaves 15% on the table,” and that patients won’t be happy being seen by a PA or an NP. All of those things are false, she said.

“We really need to improve people’s understanding in a lot of different places – it’s not just at the clinician level,” she said. “It goes all the way through the operations team, and the operations team has some very old-fashioned thinking about what PAs and NPs really are, which is – they believe – clinical support staff.”

But she suggested that the phrase “working at the top of one’s license” can be used too freely – individual experience and ability will encompass a range of practices, she said.

“I’m licensed to drive a car,” she said. “But you do not want me in the Daytona 500. I am not capable of driving a race car.”

She cautioned that nurse practitioner care must still involve an element of collaboration, according to the Medicaid benefit policy manual, even if they work in states that allow NPs to provide “independent” care. They must have documentation “indicating the relationships that they have with physicians to deal with issues outside their scope of practice,” the manual says.

“Don’t ask me how people prove it,” Ms. Marriott said. “Just know that, if someone were to audit you, then you would need to show what this looks like.”

Regarding the 15% myth, she showed a calculation: Data from the Medical Group Management Association show that median annual compensation for a physician is $134 an hour and that it’s approximately $52 an hour for a PA or NP. An admission history and physical that takes an hour can be reimbursed at $102 for a physician and at 85% of that – $87 – for a PA or NP. That leaves a deficit of $32 for the physician and a surplus of $35 for the PA or NP.

“If you properly deploy your PAs and NPs, you’re going to generate positive margins,” Ms. Marriott said.

Physicians often scurry about seeing all the patients that have already been seen by a PA, she said, because they think they must capture the extra 15% reimbursement. But that is unnecessary, she said.

“Go do another admission. You should see patients because of their clinical condition. My point is not that you go running around because you want to capture the extra 15% – because that provides no additional medically necessary care.”
 

Changing practice

Many institutions continue to be hamstrung by their own bylaws in the use of NPs and PAs. It’s true that a physician doesn’t have to see every patient, unless it’s required in a hospital’s rules, Ms. Marriott noted.

“Somebody step up, get on the bylaws committee, and say, ‘Let’s update these.’ ” she said.

As for patient satisfaction, access and convenience routinely rank higher on the patient priority lists than provider credentials. “The patient wants to get off the gurney in the ED and get to a room,” she said.

But changing hospital bylaws and practices is also about the responsible use of health care dollars, Ms. Marriott affirmed.

“More patients seen in a timely fashion, and quality metrics improvement: Those are all things that are really, really important,” she said. “As a result, [if bylaws and practice patterns are changed] the physicians are hopefully going to be happier, certainly the administration is going to be happier, and the patients are going to fare better.”

Scott Faust, MS, APRN, CNP, an acute care nurse practitioner at Health Partners in St. Paul, Minn., said that teamwork without egos is crucial to success for all providers on the hospital medicine team, especially at busier moments.

“Nobody wants to be in this alone,” he said. “I think the hospitalist teams that work well are the ones that check their titles at the door.”

PAs and NPs generally agree that, as long as all clinical staffers are working within their areas of skill without being overly concerned about specific titles and roles, hospitals and patients will benefit.

“I’ve had physicians at my organization say ‘We need to have an NP and PA set of educational requirements,’ and I said, ‘We have some already for physicians, right? Why aren’t we using that?’ ” Dr. Houghton said. “I think we should have the same expectations clinically. At the end of the day, the patient deserves the same outcomes and the same care, whether they’re being cared for by a physician, an NP, or a PA.”


 

Onboarding NPs and PAs

According to SHM’s Nurse Practitioner/Physician Assistant Committee, the integration of a new NP or PA hire, whether experienced or not, requires up-front organization and planning for the employee as he or she enters into a new practice.

To that end, the NP/PA Committee created a toolkit to aid health care organizations in their integration of NP and PA staffers into hospital medicine practice groups. The document includes resources for recruiting and interviewing NPs and PAs, information about orientation and onboarding, detailed descriptions of models of care to aid in the utilization of NPs and PAs, best practices for staff retention, insights on billing and reimbursement, and ideas for program evaluation.

Readers can download the Onboarding Toolkit in PDF format at shm.hospitalmedicine.org/acton/attachment/25526/f-040f/1/-/-/-/-/SHM_NPPA_OboardingToolkit.pdf.

Nurse practitioners (NPs) and physician assistants (PAs) have become a more prominent part of the hospitalist workforce, and at many institutions, they account for a large proportion of patient care and have a powerful effect on a patient’s experience. But NP and PA roles in hospital medicine continue to evolve – and understanding what they do is still, at times, a work in progress.

One myth that persists regarding NPs and PAs is that, if you’ve seen one, you’ve seen them all.

At the 2018 Annual Conference of the Society of Hospital Medicine, Noam Shabani, MS, PA-C, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit, Boston, offered an example to help shatter this misperception.

Mr. Shabani described a 28-year-old woman who had a bachelor’s in biology with a premed track and spent 4 years as a paramedic before attending the physician assistant program at Duke University, Durham, N.C. As a new PA graduate, she was hired as a hospitalist at a community hospital in Kentucky.

Given this new PA’s clinical experience and formal education, there are certain skills she should bring to the table: the ability to develop a differential diagnosis and a good understanding of disease pathophysiology and the mechanisms of action of drugs. And because of her paramedic experience, she should be comfortable with making urgent clinical care decisions and should be proficient with electrocardiograms, as well as chest and abdominal x-rays.

But compared with a newly graduated NP with registered nurse (RN) floor experience, the PA is likely to be less familiar with hospital mechanics and systems, with leading goal of care discussions with patients and families, and with understanding nuances involved with transitions of care.

The subtle differences between NPs and PAs don’t end there. Because of the progressive policies and recently updated bylaws at the Kentucky hospital where the PA was hired, this health care professional can see patients and write notes independently without a physician signature. But because she practices in Kentucky, she is not allowed to prescribe Schedule II medications, per state law.

“This example demonstrates how nuanced and multi-layered the process of integrating NPs and PAs into hospitalist groups can be,” Mr. Shabani said.
 

Goals, roles, and expectations

Physician assistants and nurse practitioners have reported that their job descriptions, and the variety of roles they can play within HM teams, are becoming better understood by hospitalist physicians and administrators. However, they also have acknowledged that both PAs and NPs are still underutilized.

Tricia Marriott, PA-C, MPAS, an orthopedic service line administrator at Saint Mary’s Hospital in Waterbury, Conn., and an expert in NP and PA policy, has noticed growing enlightenment about PAs and NPs in her travels to conferences in recent years.

“I’m no longer explaining what a PA is and what an NP is, and the questions have become very sophisticated,” she said at HM18. “However, I spent the last two days in the exhibit hall, and some of the conversations I had with physicians are interesting in that the practice and utilization styles have not become sophisticated. So I think there is a lot of opportunity out there.”

Mr. Shabani said the hospitalist care provided by PAs and NPs sits “at the intersection” of state regulations, hospital bylaws, department utilization, and – of course – clinical experience and formal medical education.

“What this boils down to is first understanding these factors, followed by strategizing recruitment and training as a response,” he said.

Tracy Cardin, ACNP-BC, SFHM, associate director of clinical integration at Adfinitas Health in Hanover, Md., and a Society of Hospital Medicine board member, said that, even though she usually sees and hears about a 10%-15% productivity gap between physicians and PAs or NPs, there is no good reason that an experienced PA or NP should not be able to handle the same patient load as a physician hospitalist – if that’s the goal.

“Part of it is about communication of expectation,” she said, noting that organizations must provide the training to allows NPs and PAs to reach prescribed goals along with an adequate level of administrative support. “I think we shouldn’t accept those gaps in productivity.”

Nicolas Houghton, DNP, ACNP-BC, CFRN, nurse practitioner/physician assistant manager at the Cleveland Clinic, thinks that it is completely reasonable for health care organizations to have an expectation that, at the 3- to 5-year mark, NPs and PAs “are really going to be functioning at very high levels that may be nearly indistinguishable.”

Dr. Houghton and Mr. Shabani agreed that, while they had considerably different duties at the start of their careers, they now have clinical roles which mirror one another.

For example, they agreed on these basics: NPs must be a certified RN, while a PA can have any undergraduate degree with certain prerequisite courses such as biology and chemistry. All PAs are trained in general medicine, while NPs specialize in areas such as acute care, family medicine, geriatrics, and women’s health. NPs need 500 didactic hours and 500-700 clinical hours in their area of expertise, while physician assistants need 1,000 didactic and 2,000 clinical hours spread over many disciplines.

For NP’s, required clinical rotations depend on the specialty, while all PAs need to complete rotations in inpatient medicine, emergency medicine, primary care, surgery, psychiatry, pediatrics, and ob.gyn. Also, NPs can practice independently in 23 states and the District of Columbia, while PAs must have a supervising physician. About 10% of NPs work in hospital settings, and about 39% of PAs work in hospital settings, they said.

Dr. Houghton and Mr. Shabani emphasized that Medicare does recognize NP and PA services as physician services. The official language, in place since 1998, is that their services “are the type that are considered physician’s services if furnished by a doctor of medicine or osteopathy.”

Mr. Shabani said this remained a very relevant issue. “I can’t overstate how important this is,” he said.
 

Debunking myths

Several myths continue to persist about PAs and NPs, Ms. Marriott said. Some administrators and physicians believe that they can’t see new patients, that a physician must see every patient, that a physician cosignature means that a claim can be submitted under the physician’s name, that reimbursement for services provided by PAs and NPs “leaves 15% on the table,” and that patients won’t be happy being seen by a PA or an NP. All of those things are false, she said.

“We really need to improve people’s understanding in a lot of different places – it’s not just at the clinician level,” she said. “It goes all the way through the operations team, and the operations team has some very old-fashioned thinking about what PAs and NPs really are, which is – they believe – clinical support staff.”

But she suggested that the phrase “working at the top of one’s license” can be used too freely – individual experience and ability will encompass a range of practices, she said.

“I’m licensed to drive a car,” she said. “But you do not want me in the Daytona 500. I am not capable of driving a race car.”

She cautioned that nurse practitioner care must still involve an element of collaboration, according to the Medicaid benefit policy manual, even if they work in states that allow NPs to provide “independent” care. They must have documentation “indicating the relationships that they have with physicians to deal with issues outside their scope of practice,” the manual says.

“Don’t ask me how people prove it,” Ms. Marriott said. “Just know that, if someone were to audit you, then you would need to show what this looks like.”

Regarding the 15% myth, she showed a calculation: Data from the Medical Group Management Association show that median annual compensation for a physician is $134 an hour and that it’s approximately $52 an hour for a PA or NP. An admission history and physical that takes an hour can be reimbursed at $102 for a physician and at 85% of that – $87 – for a PA or NP. That leaves a deficit of $32 for the physician and a surplus of $35 for the PA or NP.

“If you properly deploy your PAs and NPs, you’re going to generate positive margins,” Ms. Marriott said.

Physicians often scurry about seeing all the patients that have already been seen by a PA, she said, because they think they must capture the extra 15% reimbursement. But that is unnecessary, she said.

“Go do another admission. You should see patients because of their clinical condition. My point is not that you go running around because you want to capture the extra 15% – because that provides no additional medically necessary care.”
 

Changing practice

Many institutions continue to be hamstrung by their own bylaws in the use of NPs and PAs. It’s true that a physician doesn’t have to see every patient, unless it’s required in a hospital’s rules, Ms. Marriott noted.

“Somebody step up, get on the bylaws committee, and say, ‘Let’s update these.’ ” she said.

As for patient satisfaction, access and convenience routinely rank higher on the patient priority lists than provider credentials. “The patient wants to get off the gurney in the ED and get to a room,” she said.

But changing hospital bylaws and practices is also about the responsible use of health care dollars, Ms. Marriott affirmed.

“More patients seen in a timely fashion, and quality metrics improvement: Those are all things that are really, really important,” she said. “As a result, [if bylaws and practice patterns are changed] the physicians are hopefully going to be happier, certainly the administration is going to be happier, and the patients are going to fare better.”

Scott Faust, MS, APRN, CNP, an acute care nurse practitioner at Health Partners in St. Paul, Minn., said that teamwork without egos is crucial to success for all providers on the hospital medicine team, especially at busier moments.

“Nobody wants to be in this alone,” he said. “I think the hospitalist teams that work well are the ones that check their titles at the door.”

PAs and NPs generally agree that, as long as all clinical staffers are working within their areas of skill without being overly concerned about specific titles and roles, hospitals and patients will benefit.

“I’ve had physicians at my organization say ‘We need to have an NP and PA set of educational requirements,’ and I said, ‘We have some already for physicians, right? Why aren’t we using that?’ ” Dr. Houghton said. “I think we should have the same expectations clinically. At the end of the day, the patient deserves the same outcomes and the same care, whether they’re being cared for by a physician, an NP, or a PA.”


 

Onboarding NPs and PAs

According to SHM’s Nurse Practitioner/Physician Assistant Committee, the integration of a new NP or PA hire, whether experienced or not, requires up-front organization and planning for the employee as he or she enters into a new practice.

To that end, the NP/PA Committee created a toolkit to aid health care organizations in their integration of NP and PA staffers into hospital medicine practice groups. The document includes resources for recruiting and interviewing NPs and PAs, information about orientation and onboarding, detailed descriptions of models of care to aid in the utilization of NPs and PAs, best practices for staff retention, insights on billing and reimbursement, and ideas for program evaluation.

Readers can download the Onboarding Toolkit in PDF format at shm.hospitalmedicine.org/acton/attachment/25526/f-040f/1/-/-/-/-/SHM_NPPA_OboardingToolkit.pdf.

Nurse practitioners (NPs) and physician assistants (PAs) have become a more prominent part of the hospitalist workforce, and at many institutions, they account for a large proportion of patient care and have a powerful effect on a patient’s experience. But NP and PA roles in hospital medicine continue to evolve – and understanding what they do is still, at times, a work in progress.

One myth that persists regarding NPs and PAs is that, if you’ve seen one, you’ve seen them all.

At the 2018 Annual Conference of the Society of Hospital Medicine, Noam Shabani, MS, PA-C, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit, Boston, offered an example to help shatter this misperception.

Mr. Shabani described a 28-year-old woman who had a bachelor’s in biology with a premed track and spent 4 years as a paramedic before attending the physician assistant program at Duke University, Durham, N.C. As a new PA graduate, she was hired as a hospitalist at a community hospital in Kentucky.

Given this new PA’s clinical experience and formal education, there are certain skills she should bring to the table: the ability to develop a differential diagnosis and a good understanding of disease pathophysiology and the mechanisms of action of drugs. And because of her paramedic experience, she should be comfortable with making urgent clinical care decisions and should be proficient with electrocardiograms, as well as chest and abdominal x-rays.

But compared with a newly graduated NP with registered nurse (RN) floor experience, the PA is likely to be less familiar with hospital mechanics and systems, with leading goal of care discussions with patients and families, and with understanding nuances involved with transitions of care.

The subtle differences between NPs and PAs don’t end there. Because of the progressive policies and recently updated bylaws at the Kentucky hospital where the PA was hired, this health care professional can see patients and write notes independently without a physician signature. But because she practices in Kentucky, she is not allowed to prescribe Schedule II medications, per state law.

“This example demonstrates how nuanced and multi-layered the process of integrating NPs and PAs into hospitalist groups can be,” Mr. Shabani said.
 

Goals, roles, and expectations

Physician assistants and nurse practitioners have reported that their job descriptions, and the variety of roles they can play within HM teams, are becoming better understood by hospitalist physicians and administrators. However, they also have acknowledged that both PAs and NPs are still underutilized.

Tricia Marriott, PA-C, MPAS, an orthopedic service line administrator at Saint Mary’s Hospital in Waterbury, Conn., and an expert in NP and PA policy, has noticed growing enlightenment about PAs and NPs in her travels to conferences in recent years.

“I’m no longer explaining what a PA is and what an NP is, and the questions have become very sophisticated,” she said at HM18. “However, I spent the last two days in the exhibit hall, and some of the conversations I had with physicians are interesting in that the practice and utilization styles have not become sophisticated. So I think there is a lot of opportunity out there.”

Mr. Shabani said the hospitalist care provided by PAs and NPs sits “at the intersection” of state regulations, hospital bylaws, department utilization, and – of course – clinical experience and formal medical education.

“What this boils down to is first understanding these factors, followed by strategizing recruitment and training as a response,” he said.

Tracy Cardin, ACNP-BC, SFHM, associate director of clinical integration at Adfinitas Health in Hanover, Md., and a Society of Hospital Medicine board member, said that, even though she usually sees and hears about a 10%-15% productivity gap between physicians and PAs or NPs, there is no good reason that an experienced PA or NP should not be able to handle the same patient load as a physician hospitalist – if that’s the goal.

“Part of it is about communication of expectation,” she said, noting that organizations must provide the training to allows NPs and PAs to reach prescribed goals along with an adequate level of administrative support. “I think we shouldn’t accept those gaps in productivity.”

Nicolas Houghton, DNP, ACNP-BC, CFRN, nurse practitioner/physician assistant manager at the Cleveland Clinic, thinks that it is completely reasonable for health care organizations to have an expectation that, at the 3- to 5-year mark, NPs and PAs “are really going to be functioning at very high levels that may be nearly indistinguishable.”

Dr. Houghton and Mr. Shabani agreed that, while they had considerably different duties at the start of their careers, they now have clinical roles which mirror one another.

For example, they agreed on these basics: NPs must be a certified RN, while a PA can have any undergraduate degree with certain prerequisite courses such as biology and chemistry. All PAs are trained in general medicine, while NPs specialize in areas such as acute care, family medicine, geriatrics, and women’s health. NPs need 500 didactic hours and 500-700 clinical hours in their area of expertise, while physician assistants need 1,000 didactic and 2,000 clinical hours spread over many disciplines.

For NP’s, required clinical rotations depend on the specialty, while all PAs need to complete rotations in inpatient medicine, emergency medicine, primary care, surgery, psychiatry, pediatrics, and ob.gyn. Also, NPs can practice independently in 23 states and the District of Columbia, while PAs must have a supervising physician. About 10% of NPs work in hospital settings, and about 39% of PAs work in hospital settings, they said.

Dr. Houghton and Mr. Shabani emphasized that Medicare does recognize NP and PA services as physician services. The official language, in place since 1998, is that their services “are the type that are considered physician’s services if furnished by a doctor of medicine or osteopathy.”

Mr. Shabani said this remained a very relevant issue. “I can’t overstate how important this is,” he said.
 

Debunking myths

Several myths continue to persist about PAs and NPs, Ms. Marriott said. Some administrators and physicians believe that they can’t see new patients, that a physician must see every patient, that a physician cosignature means that a claim can be submitted under the physician’s name, that reimbursement for services provided by PAs and NPs “leaves 15% on the table,” and that patients won’t be happy being seen by a PA or an NP. All of those things are false, she said.

“We really need to improve people’s understanding in a lot of different places – it’s not just at the clinician level,” she said. “It goes all the way through the operations team, and the operations team has some very old-fashioned thinking about what PAs and NPs really are, which is – they believe – clinical support staff.”

But she suggested that the phrase “working at the top of one’s license” can be used too freely – individual experience and ability will encompass a range of practices, she said.

“I’m licensed to drive a car,” she said. “But you do not want me in the Daytona 500. I am not capable of driving a race car.”

She cautioned that nurse practitioner care must still involve an element of collaboration, according to the Medicaid benefit policy manual, even if they work in states that allow NPs to provide “independent” care. They must have documentation “indicating the relationships that they have with physicians to deal with issues outside their scope of practice,” the manual says.

“Don’t ask me how people prove it,” Ms. Marriott said. “Just know that, if someone were to audit you, then you would need to show what this looks like.”

Regarding the 15% myth, she showed a calculation: Data from the Medical Group Management Association show that median annual compensation for a physician is $134 an hour and that it’s approximately $52 an hour for a PA or NP. An admission history and physical that takes an hour can be reimbursed at $102 for a physician and at 85% of that – $87 – for a PA or NP. That leaves a deficit of $32 for the physician and a surplus of $35 for the PA or NP.

“If you properly deploy your PAs and NPs, you’re going to generate positive margins,” Ms. Marriott said.

Physicians often scurry about seeing all the patients that have already been seen by a PA, she said, because they think they must capture the extra 15% reimbursement. But that is unnecessary, she said.

“Go do another admission. You should see patients because of their clinical condition. My point is not that you go running around because you want to capture the extra 15% – because that provides no additional medically necessary care.”
 

Changing practice

Many institutions continue to be hamstrung by their own bylaws in the use of NPs and PAs. It’s true that a physician doesn’t have to see every patient, unless it’s required in a hospital’s rules, Ms. Marriott noted.

“Somebody step up, get on the bylaws committee, and say, ‘Let’s update these.’ ” she said.

As for patient satisfaction, access and convenience routinely rank higher on the patient priority lists than provider credentials. “The patient wants to get off the gurney in the ED and get to a room,” she said.

But changing hospital bylaws and practices is also about the responsible use of health care dollars, Ms. Marriott affirmed.

“More patients seen in a timely fashion, and quality metrics improvement: Those are all things that are really, really important,” she said. “As a result, [if bylaws and practice patterns are changed] the physicians are hopefully going to be happier, certainly the administration is going to be happier, and the patients are going to fare better.”

Scott Faust, MS, APRN, CNP, an acute care nurse practitioner at Health Partners in St. Paul, Minn., said that teamwork without egos is crucial to success for all providers on the hospital medicine team, especially at busier moments.

“Nobody wants to be in this alone,” he said. “I think the hospitalist teams that work well are the ones that check their titles at the door.”

PAs and NPs generally agree that, as long as all clinical staffers are working within their areas of skill without being overly concerned about specific titles and roles, hospitals and patients will benefit.

“I’ve had physicians at my organization say ‘We need to have an NP and PA set of educational requirements,’ and I said, ‘We have some already for physicians, right? Why aren’t we using that?’ ” Dr. Houghton said. “I think we should have the same expectations clinically. At the end of the day, the patient deserves the same outcomes and the same care, whether they’re being cared for by a physician, an NP, or a PA.”


 

Onboarding NPs and PAs

According to SHM’s Nurse Practitioner/Physician Assistant Committee, the integration of a new NP or PA hire, whether experienced or not, requires up-front organization and planning for the employee as he or she enters into a new practice.

To that end, the NP/PA Committee created a toolkit to aid health care organizations in their integration of NP and PA staffers into hospital medicine practice groups. The document includes resources for recruiting and interviewing NPs and PAs, information about orientation and onboarding, detailed descriptions of models of care to aid in the utilization of NPs and PAs, best practices for staff retention, insights on billing and reimbursement, and ideas for program evaluation.

Readers can download the Onboarding Toolkit in PDF format at shm.hospitalmedicine.org/acton/attachment/25526/f-040f/1/-/-/-/-/SHM_NPPA_OboardingToolkit.pdf.

At least four new trials in mantle cell lymphoma (MCL) are preparing to launch, according to records posted on Clinicaltrials.gov.

The range of new studies are occurring around the world and examine the association of lenalidomide with tumor flare reaction, maintenance ixazomib for newly diagnosed patients, the addition of bortezomib to ibrutinib in ibrutinib-released patients, and acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab in untreated patients.

Acalabrutinib With Alternating Cycles of Bendamustine/Rituximab and Cytarabine/Rituximab for Untreated Mantle Cell Lymphoma (NCT03623373) is slated to start on Oct. 31, 2018, and be completed in 2025.

The trial, which is not yet recruiting, is estimated to enroll 15 participants. The phase 1 study will be aimed at evaluating the efficacy and safety of acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab in MCL patients who are treatment naive. The primary outcome measure is stem cell mobilization success rate in patients treated with this regimen. The phase 1 study is preparation for a larger cooperative group trial that aims to achieve a standard induction regimen for MCL in transplant-eligible patients.

The study is sponsored by Washington University, St. Louis, in collaboration with Acerta Pharma.

Ibrutinib-relapsed MCL

Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma (NCT03617484) is scheduled to start in September 2018 and be completed in 2021. It is estimated to enroll 35 patients but is not yet recruiting.

The phase 2, open-label study is aimed at evaluating the efficacy of the ibrutinib/bortezomib in MCL patients who relapsed on ibrutinib alone. The primary outcome is the overall response rate at 6 months based on the Lugano criteria.

The trial is sponsored by the University of Michigan, Ann Arbor.

Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma (NCT03616782) launched in August 2018 and is expected to be completed in 2022.

The phase 2 trial is expected to enroll 98 patients but has not started recruitment yet. In the open-label, multicenter study, newly diagnosed MCL patients will receive induction chemotherapy and those who achieve at least a partial response will be eligible to move on to the experimental phase – maintenance ixazomib. At least 8 weeks after completing induction, patients can receive ixazomib orally on days 1, 8, and 15 for 4 weeks. Treatment repeats every 4 weeks for up to 2 years unless the disease progresses or there is unacceptable toxicity. The primary outcome measure is 2-year progression-free survival.

The trial is sponsored by Ho Sup Lee, MD, of Kosin University Gospel Hospital in Busan, South Korea, in collaboration with Takeda.

PASS MCL-005

The Noninterventional Study in Patients With Relapsed or Refractory Mantle Cell Lymphoma (R/R MCL) to Investigate the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden, called PASS MCL-005 (NCT03647124) is slated to start at the end of September 2018 and wrap up in 2026.

The retrospective cohort study will rely on data collection from Nordic registries and national health databases. The researchers will analyze records from sites where lenalidomide treatment for relapsed/refractory MCL is reimbursed. The estimated enrollment is 560 participants.

The primary goal is to quantify and characterize the event of tumor flare reaction by tumor burden in relapsed/refractory MCL patients who were treated with lenalidomide in a real-world setting.

The European-based study is sponsored by Celgene.

[email protected]

At least four new trials in mantle cell lymphoma (MCL) are preparing to launch, according to records posted on Clinicaltrials.gov.

The range of new studies are occurring around the world and examine the association of lenalidomide with tumor flare reaction, maintenance ixazomib for newly diagnosed patients, the addition of bortezomib to ibrutinib in ibrutinib-released patients, and acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab in untreated patients.

Acalabrutinib With Alternating Cycles of Bendamustine/Rituximab and Cytarabine/Rituximab for Untreated Mantle Cell Lymphoma (NCT03623373) is slated to start on Oct. 31, 2018, and be completed in 2025.

The trial, which is not yet recruiting, is estimated to enroll 15 participants. The phase 1 study will be aimed at evaluating the efficacy and safety of acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab in MCL patients who are treatment naive. The primary outcome measure is stem cell mobilization success rate in patients treated with this regimen. The phase 1 study is preparation for a larger cooperative group trial that aims to achieve a standard induction regimen for MCL in transplant-eligible patients.

The study is sponsored by Washington University, St. Louis, in collaboration with Acerta Pharma.

Ibrutinib-relapsed MCL

Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma (NCT03617484) is scheduled to start in September 2018 and be completed in 2021. It is estimated to enroll 35 patients but is not yet recruiting.

The phase 2, open-label study is aimed at evaluating the efficacy of the ibrutinib/bortezomib in MCL patients who relapsed on ibrutinib alone. The primary outcome is the overall response rate at 6 months based on the Lugano criteria.

The trial is sponsored by the University of Michigan, Ann Arbor.

Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma (NCT03616782) launched in August 2018 and is expected to be completed in 2022.

The phase 2 trial is expected to enroll 98 patients but has not started recruitment yet. In the open-label, multicenter study, newly diagnosed MCL patients will receive induction chemotherapy and those who achieve at least a partial response will be eligible to move on to the experimental phase – maintenance ixazomib. At least 8 weeks after completing induction, patients can receive ixazomib orally on days 1, 8, and 15 for 4 weeks. Treatment repeats every 4 weeks for up to 2 years unless the disease progresses or there is unacceptable toxicity. The primary outcome measure is 2-year progression-free survival.

The trial is sponsored by Ho Sup Lee, MD, of Kosin University Gospel Hospital in Busan, South Korea, in collaboration with Takeda.

PASS MCL-005

The Noninterventional Study in Patients With Relapsed or Refractory Mantle Cell Lymphoma (R/R MCL) to Investigate the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden, called PASS MCL-005 (NCT03647124) is slated to start at the end of September 2018 and wrap up in 2026.

The retrospective cohort study will rely on data collection from Nordic registries and national health databases. The researchers will analyze records from sites where lenalidomide treatment for relapsed/refractory MCL is reimbursed. The estimated enrollment is 560 participants.

The primary goal is to quantify and characterize the event of tumor flare reaction by tumor burden in relapsed/refractory MCL patients who were treated with lenalidomide in a real-world setting.

The European-based study is sponsored by Celgene.

[email protected]

At least four new trials in mantle cell lymphoma (MCL) are preparing to launch, according to records posted on Clinicaltrials.gov.

The range of new studies are occurring around the world and examine the association of lenalidomide with tumor flare reaction, maintenance ixazomib for newly diagnosed patients, the addition of bortezomib to ibrutinib in ibrutinib-released patients, and acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab in untreated patients.

Acalabrutinib With Alternating Cycles of Bendamustine/Rituximab and Cytarabine/Rituximab for Untreated Mantle Cell Lymphoma (NCT03623373) is slated to start on Oct. 31, 2018, and be completed in 2025.

The trial, which is not yet recruiting, is estimated to enroll 15 participants. The phase 1 study will be aimed at evaluating the efficacy and safety of acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab in MCL patients who are treatment naive. The primary outcome measure is stem cell mobilization success rate in patients treated with this regimen. The phase 1 study is preparation for a larger cooperative group trial that aims to achieve a standard induction regimen for MCL in transplant-eligible patients.

The study is sponsored by Washington University, St. Louis, in collaboration with Acerta Pharma.

Ibrutinib-relapsed MCL

Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma (NCT03617484) is scheduled to start in September 2018 and be completed in 2021. It is estimated to enroll 35 patients but is not yet recruiting.

The phase 2, open-label study is aimed at evaluating the efficacy of the ibrutinib/bortezomib in MCL patients who relapsed on ibrutinib alone. The primary outcome is the overall response rate at 6 months based on the Lugano criteria.

The trial is sponsored by the University of Michigan, Ann Arbor.

Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma (NCT03616782) launched in August 2018 and is expected to be completed in 2022.

The phase 2 trial is expected to enroll 98 patients but has not started recruitment yet. In the open-label, multicenter study, newly diagnosed MCL patients will receive induction chemotherapy and those who achieve at least a partial response will be eligible to move on to the experimental phase – maintenance ixazomib. At least 8 weeks after completing induction, patients can receive ixazomib orally on days 1, 8, and 15 for 4 weeks. Treatment repeats every 4 weeks for up to 2 years unless the disease progresses or there is unacceptable toxicity. The primary outcome measure is 2-year progression-free survival.

The trial is sponsored by Ho Sup Lee, MD, of Kosin University Gospel Hospital in Busan, South Korea, in collaboration with Takeda.

PASS MCL-005

The Noninterventional Study in Patients With Relapsed or Refractory Mantle Cell Lymphoma (R/R MCL) to Investigate the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden, called PASS MCL-005 (NCT03647124) is slated to start at the end of September 2018 and wrap up in 2026.

The retrospective cohort study will rely on data collection from Nordic registries and national health databases. The researchers will analyze records from sites where lenalidomide treatment for relapsed/refractory MCL is reimbursed. The estimated enrollment is 560 participants.

The primary goal is to quantify and characterize the event of tumor flare reaction by tumor burden in relapsed/refractory MCL patients who were treated with lenalidomide in a real-world setting.

The European-based study is sponsored by Celgene.

[email protected]

SAN DIEGO – According to J. Stuart Nelson, MD, PhD, three general principles guide the laser treatment of vascular skin lesions. The first is to target blood vessels beneath the surface of the skin.

“You’re going to be using wavelengths of light generally in the green and yellow portion of the spectrum,” Dr. Nelson, professor of surgery and biomedical engineering at the Beckman Laser Institute and Medical Clinic at the University of California, Irvine, said at the annual Masters of Aesthetics Symposium. “Blue light is highly absorbed by hemoglobin but unfortunately, blue light is highly scattered by human skin, so it won’t penetrate deep enough into the dermis. So primarily, we’re targeting hemoglobin using green and yellow light sources.”

The second principle is to match the pulse width with the vessel size, while the third is to give sufficient energy to irreversibly injure vessels based on selective photothermolysis.

Next, he advised clinicians to ask themselves three questions: What is the vessel size? “The larger the vessel, the longer the thermal relaxation time,” he said. What is the vessel depth? Deeper vessels require longer wavelengths of light and larger spot sizes. What is the patient’s skin phototype? Darker skin contains more epidermal melanin and requires extra caution during treatment.

Dr. Nelson listed seven optimal devices for the treatment of vascular skin lesions: intense pulsed light (IPL) with wavelengths of 515-1,200 nm and pulse durations of 1-10 ms, pulsed green light with a wavelength of 532 nm and pulse durations of 1-50 ms, pulsed dye yellow light with wavelengths of 585-600 nm and pulse durations of 0.5-40 ms, pulsed dye plus Nd:YAG with wavelengths of 595 and 1,064 nm and pulse durations of 0.5-40 ms, alexandrite laser with a wavelength of 755 nm and pulse durations of 0.25-100 ms, diode laser with a wavelength of 940 nm and pulse durations of 5-100 ms, and the pulsed Nd:YAG laser with a wavelength of 1,064 nm and pulse durations of 0.25-100 ms.

“You can get good results with every one of these devices,” Dr. Nelson said. “What you need to do is pick one and become what R. Rox Anderson, MD, calls an ‘endpointologist,’ so you can understand the clinical endpoints. Do not use a cookbook approach by trying to memorize treatment settings.”

Pulsed dye lasers with a wavelength of 585-600 nm have been the standard of care for years, he said, and is the treatment of choice for port wine stains in infants and young children. Upsides include the ability to treat large areas quickly and the ability to use two to three separate passes. It also induces diminution in diffuse redness and telangiectasia. Drawbacks include its potential to cause purpura when short pulse durations are used, it requires several treatments, it can be painful, and it causes considerable edema and erythema.

Millisecond green lasers at a wavelength of 532 nm are also effective for treating vascular skin lesions. “The nice thing about these devices is that you can focus them down to very small spots, so you can literally trace out individual blood vessels,” Dr. Nelson said. Other upsides include the fact that it can be performed without producing purpura, only transient erythema if few areas are treated. Drawbacks are that it’s moderately painful and may cause considerable edema. It also causes significant melanin absorption so is not advised for use in tanned and darker-skinned individuals. For all patients, contact cooling must be assured.

IPL, meanwhile, “can be very useful for treating not only vascular lesions, but also concurrently pigmented lesions such as poikiloderma of Civatte,” Dr. Nelson said. Potential drawbacks to IPL therapy are that the spectrum of light emitted and the pulse duration characteristics vary between devices and multiple treatments are required.

Finally, in the millisecond domain, the pulsed alexandrite 755-nm and Nd:YAG 1,064-nm lasers “are very good when trying to target something very deep in the skin like a vein,” he said. “But when you’re using those devices, you’re coagulating a large volume of tissue, so you need to be very careful about the amount of heat that you’re generating deep in the skin.”

When consulting with patients who have rosacea or telangiectasia, Dr. Nelson tells them multiple treatments will be required. “These are chronic conditions, and they may need ongoing maintenance treatments. The nice thing about all these procedures you’re doing for rosacea and telangiectasia is that they can be combined with all of your FDA [Food and Drug Administration]-approved topical and oral treatment protocols. All of these drugs you have at your disposal to medically treat rosacea can be all used concurrently with your laser treatment. When you see a patient you need to emphasize to them: ‘I’m not treating your rosacea with the laser. I’m treating a symptom of your rosacea with the laser.’ ”

Dr. Nelson closed his presentation by offering basic principles for success, the first being do no harm. “That’s the single most important thing you want to remember. No one will get mad if the blood vessel’s still there, but they’ll get very mad if something bad happens. You also want to underpromise and overdeliver. I always tell patients it’s going to require two to four treatments. When in doubt, don’t treat or undertreat. You can always treat again.”

If you’re concerned, perform a test spot. “There’s nothing wrong with that, particularly in a patient where you’re not sure what the outcome will be,” he said. “Check for any unusual skin reaction and for potential success of the procedure. Finally, don’t treat patients who are tanned.”

Dr. Nelson reported having intellectual property rights with Syneron Candela.

[email protected]

SAN DIEGO – According to J. Stuart Nelson, MD, PhD, three general principles guide the laser treatment of vascular skin lesions. The first is to target blood vessels beneath the surface of the skin.

“You’re going to be using wavelengths of light generally in the green and yellow portion of the spectrum,” Dr. Nelson, professor of surgery and biomedical engineering at the Beckman Laser Institute and Medical Clinic at the University of California, Irvine, said at the annual Masters of Aesthetics Symposium. “Blue light is highly absorbed by hemoglobin but unfortunately, blue light is highly scattered by human skin, so it won’t penetrate deep enough into the dermis. So primarily, we’re targeting hemoglobin using green and yellow light sources.”

The second principle is to match the pulse width with the vessel size, while the third is to give sufficient energy to irreversibly injure vessels based on selective photothermolysis.

Next, he advised clinicians to ask themselves three questions: What is the vessel size? “The larger the vessel, the longer the thermal relaxation time,” he said. What is the vessel depth? Deeper vessels require longer wavelengths of light and larger spot sizes. What is the patient’s skin phototype? Darker skin contains more epidermal melanin and requires extra caution during treatment.

Dr. Nelson listed seven optimal devices for the treatment of vascular skin lesions: intense pulsed light (IPL) with wavelengths of 515-1,200 nm and pulse durations of 1-10 ms, pulsed green light with a wavelength of 532 nm and pulse durations of 1-50 ms, pulsed dye yellow light with wavelengths of 585-600 nm and pulse durations of 0.5-40 ms, pulsed dye plus Nd:YAG with wavelengths of 595 and 1,064 nm and pulse durations of 0.5-40 ms, alexandrite laser with a wavelength of 755 nm and pulse durations of 0.25-100 ms, diode laser with a wavelength of 940 nm and pulse durations of 5-100 ms, and the pulsed Nd:YAG laser with a wavelength of 1,064 nm and pulse durations of 0.25-100 ms.

“You can get good results with every one of these devices,” Dr. Nelson said. “What you need to do is pick one and become what R. Rox Anderson, MD, calls an ‘endpointologist,’ so you can understand the clinical endpoints. Do not use a cookbook approach by trying to memorize treatment settings.”

Pulsed dye lasers with a wavelength of 585-600 nm have been the standard of care for years, he said, and is the treatment of choice for port wine stains in infants and young children. Upsides include the ability to treat large areas quickly and the ability to use two to three separate passes. It also induces diminution in diffuse redness and telangiectasia. Drawbacks include its potential to cause purpura when short pulse durations are used, it requires several treatments, it can be painful, and it causes considerable edema and erythema.

Millisecond green lasers at a wavelength of 532 nm are also effective for treating vascular skin lesions. “The nice thing about these devices is that you can focus them down to very small spots, so you can literally trace out individual blood vessels,” Dr. Nelson said. Other upsides include the fact that it can be performed without producing purpura, only transient erythema if few areas are treated. Drawbacks are that it’s moderately painful and may cause considerable edema. It also causes significant melanin absorption so is not advised for use in tanned and darker-skinned individuals. For all patients, contact cooling must be assured.

IPL, meanwhile, “can be very useful for treating not only vascular lesions, but also concurrently pigmented lesions such as poikiloderma of Civatte,” Dr. Nelson said. Potential drawbacks to IPL therapy are that the spectrum of light emitted and the pulse duration characteristics vary between devices and multiple treatments are required.

Finally, in the millisecond domain, the pulsed alexandrite 755-nm and Nd:YAG 1,064-nm lasers “are very good when trying to target something very deep in the skin like a vein,” he said. “But when you’re using those devices, you’re coagulating a large volume of tissue, so you need to be very careful about the amount of heat that you’re generating deep in the skin.”

When consulting with patients who have rosacea or telangiectasia, Dr. Nelson tells them multiple treatments will be required. “These are chronic conditions, and they may need ongoing maintenance treatments. The nice thing about all these procedures you’re doing for rosacea and telangiectasia is that they can be combined with all of your FDA [Food and Drug Administration]-approved topical and oral treatment protocols. All of these drugs you have at your disposal to medically treat rosacea can be all used concurrently with your laser treatment. When you see a patient you need to emphasize to them: ‘I’m not treating your rosacea with the laser. I’m treating a symptom of your rosacea with the laser.’ ”

Dr. Nelson closed his presentation by offering basic principles for success, the first being do no harm. “That’s the single most important thing you want to remember. No one will get mad if the blood vessel’s still there, but they’ll get very mad if something bad happens. You also want to underpromise and overdeliver. I always tell patients it’s going to require two to four treatments. When in doubt, don’t treat or undertreat. You can always treat again.”

If you’re concerned, perform a test spot. “There’s nothing wrong with that, particularly in a patient where you’re not sure what the outcome will be,” he said. “Check for any unusual skin reaction and for potential success of the procedure. Finally, don’t treat patients who are tanned.”

Dr. Nelson reported having intellectual property rights with Syneron Candela.

[email protected]

SAN DIEGO – According to J. Stuart Nelson, MD, PhD, three general principles guide the laser treatment of vascular skin lesions. The first is to target blood vessels beneath the surface of the skin.

“You’re going to be using wavelengths of light generally in the green and yellow portion of the spectrum,” Dr. Nelson, professor of surgery and biomedical engineering at the Beckman Laser Institute and Medical Clinic at the University of California, Irvine, said at the annual Masters of Aesthetics Symposium. “Blue light is highly absorbed by hemoglobin but unfortunately, blue light is highly scattered by human skin, so it won’t penetrate deep enough into the dermis. So primarily, we’re targeting hemoglobin using green and yellow light sources.”

The second principle is to match the pulse width with the vessel size, while the third is to give sufficient energy to irreversibly injure vessels based on selective photothermolysis.

Next, he advised clinicians to ask themselves three questions: What is the vessel size? “The larger the vessel, the longer the thermal relaxation time,” he said. What is the vessel depth? Deeper vessels require longer wavelengths of light and larger spot sizes. What is the patient’s skin phototype? Darker skin contains more epidermal melanin and requires extra caution during treatment.

Dr. Nelson listed seven optimal devices for the treatment of vascular skin lesions: intense pulsed light (IPL) with wavelengths of 515-1,200 nm and pulse durations of 1-10 ms, pulsed green light with a wavelength of 532 nm and pulse durations of 1-50 ms, pulsed dye yellow light with wavelengths of 585-600 nm and pulse durations of 0.5-40 ms, pulsed dye plus Nd:YAG with wavelengths of 595 and 1,064 nm and pulse durations of 0.5-40 ms, alexandrite laser with a wavelength of 755 nm and pulse durations of 0.25-100 ms, diode laser with a wavelength of 940 nm and pulse durations of 5-100 ms, and the pulsed Nd:YAG laser with a wavelength of 1,064 nm and pulse durations of 0.25-100 ms.

“You can get good results with every one of these devices,” Dr. Nelson said. “What you need to do is pick one and become what R. Rox Anderson, MD, calls an ‘endpointologist,’ so you can understand the clinical endpoints. Do not use a cookbook approach by trying to memorize treatment settings.”

Pulsed dye lasers with a wavelength of 585-600 nm have been the standard of care for years, he said, and is the treatment of choice for port wine stains in infants and young children. Upsides include the ability to treat large areas quickly and the ability to use two to three separate passes. It also induces diminution in diffuse redness and telangiectasia. Drawbacks include its potential to cause purpura when short pulse durations are used, it requires several treatments, it can be painful, and it causes considerable edema and erythema.

Millisecond green lasers at a wavelength of 532 nm are also effective for treating vascular skin lesions. “The nice thing about these devices is that you can focus them down to very small spots, so you can literally trace out individual blood vessels,” Dr. Nelson said. Other upsides include the fact that it can be performed without producing purpura, only transient erythema if few areas are treated. Drawbacks are that it’s moderately painful and may cause considerable edema. It also causes significant melanin absorption so is not advised for use in tanned and darker-skinned individuals. For all patients, contact cooling must be assured.

IPL, meanwhile, “can be very useful for treating not only vascular lesions, but also concurrently pigmented lesions such as poikiloderma of Civatte,” Dr. Nelson said. Potential drawbacks to IPL therapy are that the spectrum of light emitted and the pulse duration characteristics vary between devices and multiple treatments are required.

Finally, in the millisecond domain, the pulsed alexandrite 755-nm and Nd:YAG 1,064-nm lasers “are very good when trying to target something very deep in the skin like a vein,” he said. “But when you’re using those devices, you’re coagulating a large volume of tissue, so you need to be very careful about the amount of heat that you’re generating deep in the skin.”

When consulting with patients who have rosacea or telangiectasia, Dr. Nelson tells them multiple treatments will be required. “These are chronic conditions, and they may need ongoing maintenance treatments. The nice thing about all these procedures you’re doing for rosacea and telangiectasia is that they can be combined with all of your FDA [Food and Drug Administration]-approved topical and oral treatment protocols. All of these drugs you have at your disposal to medically treat rosacea can be all used concurrently with your laser treatment. When you see a patient you need to emphasize to them: ‘I’m not treating your rosacea with the laser. I’m treating a symptom of your rosacea with the laser.’ ”

Dr. Nelson closed his presentation by offering basic principles for success, the first being do no harm. “That’s the single most important thing you want to remember. No one will get mad if the blood vessel’s still there, but they’ll get very mad if something bad happens. You also want to underpromise and overdeliver. I always tell patients it’s going to require two to four treatments. When in doubt, don’t treat or undertreat. You can always treat again.”

If you’re concerned, perform a test spot. “There’s nothing wrong with that, particularly in a patient where you’re not sure what the outcome will be,” he said. “Check for any unusual skin reaction and for potential success of the procedure. Finally, don’t treat patients who are tanned.”

Dr. Nelson reported having intellectual property rights with Syneron Candela.

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