Our new year’s resolutions

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Be at war with your vices, at peace with your neighbors, and let every new year find you a better person.

– Benjamin Franklin

Traditionally, the new year is a time for reflection, looking back to review what could have been done better, and looking forward to the opportunity to rectify those inadequacies over the coming year. We thought we would take this opportunity to look at our use of the electronic health record and think about the things we might do over the next year to make our lives easier and our charting better.

Top of our list is a renewed commitment to finish our notes by the end of each session. Too many physicians we know rush through patient hours and then are left with 10-20 notes to finish at the end of the day. Realistically, this is when we least feel like completing notes. Such work encroaches on personal and family time, likely contributes to the burnout that has been increasing among physicians, and is much less likely to accurately represent the encounter than notes completed in real time.

Dr. Chris Notte and Dr. Neil Skolnik
One way of becoming more efficient will involve a new commitment to learning how to use templates and macros more effectively. Templates and macros let us essentially prepopulate our note with the verbiage, tests, and medications that we typically order for the diagnoses we most commonly see.

As we have spoken with many of our colleagues, it has become clear to us that many clinicians have learned how to be “just proficient enough” in their use of their EHR; they are not pulling out their hair every 5 minutes in frustration, but they have not taken the extra time and effort that are needed to optimize their productivity. To efficiently use an EHR requires some time spent designing templates and macros to make it easy to repetitively carry out common tasks.

A lot of physicians – particularly physicians over 40 years of age – are still typing their notes with the ol’ two-finger hunt-and-peck technique. This is incredibly time consuming, inefficient, and frustrating.

While many solutions have been proposed, including having a scribe walk around with the doctor, the simplest and easiest to implement is voice transcription. Even though medical transcription software is expensive, the return on investment is large for those who do not type well. After a short period of training on the software, notes are generally of higher quality and are finished considerably faster than when typing. The technology also has the ability to learn the names of frequently used consultants, medications, and procedures, so users don’t even have to type uncommon names or words.

Another area in which we hope to advance over the next year is working more effectively as a team to share the documentation burden. Nurses and medical assistants – within the boundaries of their licensing – can be empowered to document in predefined areas of the chart as much as possible.

For example, given the fact that the prevalence of depression is about twice as high in patients with diabetes as it is in the general population, our medical assistants now screen our diabetes patients with a PHQ-2 depression screen and record the results in the chart. This has been good for our patients, satisfying for our medical assistants, and has offloaded this task from the doctors.

We need to think of more areas where we can facilitate team care and really make everyone – physicians, nurses, front staff, and patients – more satisfied with the care that is being given.

Most EHRs have a reminder function – the ability to prompt a user to follow up on an abnormal x-ray or lab results in case a patient does not come back into the office as recommended. Our sense is that most of us are not using this function. It is worth finding out how to use it and giving it a try.

Patient portals have gained a lot of traction over the past few years. For a little while, we were really making an effort to have patients register, so that currently many (but by far not most) of our patients have signed up. We want to make better use of this fantastic resource.

We say “fantastic” because when we talk to patients (or friends or family) who use the portal, they have shared that it really makes their lives easier. They are able to see their labs, ponder the meaning of their results (perhaps of a slightly high glucose or an LDL cholesterol level), and if they have questions, they can correspond electronically with their care providers. It enhances care and allows us to spend less time on the phone, while giving patients better access to information.

New year’s resolutions are an opportunity for reflection and optimism. As we look back on the past year, we should learn from our experience and approach the year in front of us with greater enthusiasm, in the hope that through that enthusiasm we can continue to grow, be better and healthier, and simply be more like the people we want to be.

The electronic health record affects all of our interactions with patients and colleagues, and, when not used optimally, encroaches into our personal and family lives. It is a perfect place to focus during the new year to enable us to have more productive, effective, and happier times both in the office and at home.
 

 

 

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

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Be at war with your vices, at peace with your neighbors, and let every new year find you a better person.

– Benjamin Franklin

Traditionally, the new year is a time for reflection, looking back to review what could have been done better, and looking forward to the opportunity to rectify those inadequacies over the coming year. We thought we would take this opportunity to look at our use of the electronic health record and think about the things we might do over the next year to make our lives easier and our charting better.

Top of our list is a renewed commitment to finish our notes by the end of each session. Too many physicians we know rush through patient hours and then are left with 10-20 notes to finish at the end of the day. Realistically, this is when we least feel like completing notes. Such work encroaches on personal and family time, likely contributes to the burnout that has been increasing among physicians, and is much less likely to accurately represent the encounter than notes completed in real time.

Dr. Chris Notte and Dr. Neil Skolnik
One way of becoming more efficient will involve a new commitment to learning how to use templates and macros more effectively. Templates and macros let us essentially prepopulate our note with the verbiage, tests, and medications that we typically order for the diagnoses we most commonly see.

As we have spoken with many of our colleagues, it has become clear to us that many clinicians have learned how to be “just proficient enough” in their use of their EHR; they are not pulling out their hair every 5 minutes in frustration, but they have not taken the extra time and effort that are needed to optimize their productivity. To efficiently use an EHR requires some time spent designing templates and macros to make it easy to repetitively carry out common tasks.

A lot of physicians – particularly physicians over 40 years of age – are still typing their notes with the ol’ two-finger hunt-and-peck technique. This is incredibly time consuming, inefficient, and frustrating.

While many solutions have been proposed, including having a scribe walk around with the doctor, the simplest and easiest to implement is voice transcription. Even though medical transcription software is expensive, the return on investment is large for those who do not type well. After a short period of training on the software, notes are generally of higher quality and are finished considerably faster than when typing. The technology also has the ability to learn the names of frequently used consultants, medications, and procedures, so users don’t even have to type uncommon names or words.

Another area in which we hope to advance over the next year is working more effectively as a team to share the documentation burden. Nurses and medical assistants – within the boundaries of their licensing – can be empowered to document in predefined areas of the chart as much as possible.

For example, given the fact that the prevalence of depression is about twice as high in patients with diabetes as it is in the general population, our medical assistants now screen our diabetes patients with a PHQ-2 depression screen and record the results in the chart. This has been good for our patients, satisfying for our medical assistants, and has offloaded this task from the doctors.

We need to think of more areas where we can facilitate team care and really make everyone – physicians, nurses, front staff, and patients – more satisfied with the care that is being given.

Most EHRs have a reminder function – the ability to prompt a user to follow up on an abnormal x-ray or lab results in case a patient does not come back into the office as recommended. Our sense is that most of us are not using this function. It is worth finding out how to use it and giving it a try.

Patient portals have gained a lot of traction over the past few years. For a little while, we were really making an effort to have patients register, so that currently many (but by far not most) of our patients have signed up. We want to make better use of this fantastic resource.

We say “fantastic” because when we talk to patients (or friends or family) who use the portal, they have shared that it really makes their lives easier. They are able to see their labs, ponder the meaning of their results (perhaps of a slightly high glucose or an LDL cholesterol level), and if they have questions, they can correspond electronically with their care providers. It enhances care and allows us to spend less time on the phone, while giving patients better access to information.

New year’s resolutions are an opportunity for reflection and optimism. As we look back on the past year, we should learn from our experience and approach the year in front of us with greater enthusiasm, in the hope that through that enthusiasm we can continue to grow, be better and healthier, and simply be more like the people we want to be.

The electronic health record affects all of our interactions with patients and colleagues, and, when not used optimally, encroaches into our personal and family lives. It is a perfect place to focus during the new year to enable us to have more productive, effective, and happier times both in the office and at home.
 

 

 

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

 

Be at war with your vices, at peace with your neighbors, and let every new year find you a better person.

– Benjamin Franklin

Traditionally, the new year is a time for reflection, looking back to review what could have been done better, and looking forward to the opportunity to rectify those inadequacies over the coming year. We thought we would take this opportunity to look at our use of the electronic health record and think about the things we might do over the next year to make our lives easier and our charting better.

Top of our list is a renewed commitment to finish our notes by the end of each session. Too many physicians we know rush through patient hours and then are left with 10-20 notes to finish at the end of the day. Realistically, this is when we least feel like completing notes. Such work encroaches on personal and family time, likely contributes to the burnout that has been increasing among physicians, and is much less likely to accurately represent the encounter than notes completed in real time.

Dr. Chris Notte and Dr. Neil Skolnik
One way of becoming more efficient will involve a new commitment to learning how to use templates and macros more effectively. Templates and macros let us essentially prepopulate our note with the verbiage, tests, and medications that we typically order for the diagnoses we most commonly see.

As we have spoken with many of our colleagues, it has become clear to us that many clinicians have learned how to be “just proficient enough” in their use of their EHR; they are not pulling out their hair every 5 minutes in frustration, but they have not taken the extra time and effort that are needed to optimize their productivity. To efficiently use an EHR requires some time spent designing templates and macros to make it easy to repetitively carry out common tasks.

A lot of physicians – particularly physicians over 40 years of age – are still typing their notes with the ol’ two-finger hunt-and-peck technique. This is incredibly time consuming, inefficient, and frustrating.

While many solutions have been proposed, including having a scribe walk around with the doctor, the simplest and easiest to implement is voice transcription. Even though medical transcription software is expensive, the return on investment is large for those who do not type well. After a short period of training on the software, notes are generally of higher quality and are finished considerably faster than when typing. The technology also has the ability to learn the names of frequently used consultants, medications, and procedures, so users don’t even have to type uncommon names or words.

Another area in which we hope to advance over the next year is working more effectively as a team to share the documentation burden. Nurses and medical assistants – within the boundaries of their licensing – can be empowered to document in predefined areas of the chart as much as possible.

For example, given the fact that the prevalence of depression is about twice as high in patients with diabetes as it is in the general population, our medical assistants now screen our diabetes patients with a PHQ-2 depression screen and record the results in the chart. This has been good for our patients, satisfying for our medical assistants, and has offloaded this task from the doctors.

We need to think of more areas where we can facilitate team care and really make everyone – physicians, nurses, front staff, and patients – more satisfied with the care that is being given.

Most EHRs have a reminder function – the ability to prompt a user to follow up on an abnormal x-ray or lab results in case a patient does not come back into the office as recommended. Our sense is that most of us are not using this function. It is worth finding out how to use it and giving it a try.

Patient portals have gained a lot of traction over the past few years. For a little while, we were really making an effort to have patients register, so that currently many (but by far not most) of our patients have signed up. We want to make better use of this fantastic resource.

We say “fantastic” because when we talk to patients (or friends or family) who use the portal, they have shared that it really makes their lives easier. They are able to see their labs, ponder the meaning of their results (perhaps of a slightly high glucose or an LDL cholesterol level), and if they have questions, they can correspond electronically with their care providers. It enhances care and allows us to spend less time on the phone, while giving patients better access to information.

New year’s resolutions are an opportunity for reflection and optimism. As we look back on the past year, we should learn from our experience and approach the year in front of us with greater enthusiasm, in the hope that through that enthusiasm we can continue to grow, be better and healthier, and simply be more like the people we want to be.

The electronic health record affects all of our interactions with patients and colleagues, and, when not used optimally, encroaches into our personal and family lives. It is a perfect place to focus during the new year to enable us to have more productive, effective, and happier times both in the office and at home.
 

 

 

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

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The Role of Biologic Therapy for Psoriasis in Cardiovascular Risk Reduction

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The Role of Biologic Therapy for Psoriasis in Cardiovascular Risk Reduction

The cardiovascular comorbidities associated with psoriasis have been well documented; however, the mechanism by which psoriasis increases the risk for cardiovascular disease (CVD) remains unclear. Elevated systemic inflammatory cytokines and mediators may play a key role in their association, which prompts the questions: Do systemic medications have a protective effect? Do patients on systemic antipsoriatic treatment have a decreased risk for major adverse cardiovascular events (MACEs) compared with untreated patients?

We believe the shared inflammatory processes involved in psoriasis and atherosclerosis formation are potential targets for therapy in reducing the incidence of CVD and its associated complications. A growing amount of evidence suggests cardioprotective effects associated with antipsoriatic treatments such as tumor necrosis factor (TNF) inhibitors and methotrexate. Gkalpakiotis et al1 demonstrated a reduction in serum E-selectin (mean [standard deviation], 53.04 [23.54] ng/mL vs 35.32 [8.70] ng/mL; P<.001) and IL-22 (25.11 [19.9] pg/mL vs 12.83 [8.42] pg/mL; P<.001) after 3 months of adalimumab administration in patients with moderate to severe psoriasis. Both E-selectin and IL-22 are associated with the development of atherosclerosis, endothelial dysfunction, and an increased incidence of CVD. Similarly, Wu et al2 demonstrated a statistically significant reduction (5.04 mg/dL [95% confidence interval [CI], 8.24 to 2.12; P<.01) in C-reactive protein in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis after concurrent use of methotrexate and TNF inhibitors.

Solomon et al3 compared the rate of newly diagnosed diabetes mellitus among psoriasis and rheumatoid arthritis patients treated with TNF inhibitors, methotrexate, hydroxychloroquine, and other nonbiologic disease-modifying antirheumatic drugs. The authors’ findings suggest that those who take a TNF inhibitor (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80) are at lower risk for diabetes mellitus compared to those treated with nonbiologic disease-modifying antirheumatic drugs. Conversely, the methotrexate (HR, 0.77; 95% CI, 0.53-1.13) cohort did not show a statistically significant reduction in diabetes risk.3

Pina et al4 revealed improvement in endothelial function after 6 months of adalimumab use in patients with moderate to severe psoriasis. To evaluate the presence of subclinical endothelial dysfunction, the authors assessed brachial artery reactivity by measuring flow-mediated dilation and carotid artery stiffness by pulse wave velocity. Patients showed an increase in flow-mediated dilation (mean [SD], 6.19% [2.44%] vs 7.46% [2.43%]; P=.008) and reduction in pulse wave velocity (6.28 [1.04] m/s vs 5.69 [1.31] m/s; P=.03) compared to baseline measurements, indicating an improvement of endothelial function.4

Ahlehoff et al5 observed for improvements in subclinical left ventricular dysfunction in psoriasis patients after treatment with biologics. Using echocardiography, they assessed for changes in diastolic function and left ventricular systolic deformation (defined by global longitudinal strain). Of patients who received 3 months of biologic therapy (TNF inhibitor orIL-12/23 inhibitor) and maintained at minimum a psoriasis area and severity index 50 response, all demonstrated an improvement in diastolic function (mean [SD], 8.1 [2.1] vs 6.7 [1.9]; P<.001) and global longitudinal strain (mean [SD], 16.8% [2.1%] vs 18.3% [2.3%]; P<.001). Of note, patients who did not achieve a psoriasis area and severity index 50 response at follow-up did not exhibit an improvement in subclinical myocardial function.5

Moreover, a Danish nationwide study with up to 5-year follow-up evaluated the risk for MACE (ie, cardiovascular death, myocardial infarction, stroke) in patients with severe psoriasis receiving systemic anti-inflammatory medications and nonsystemic therapies including topical treatments, phototherapy, and climate therapy.6 Compared to nonsystemic therapies, methotrexate use (HR, 0.53; 95% CI, 0.34-0.83) was associated with a decreased risk for cardiovascular events. However, a protective decreased risk was not found among patients who used systemic cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) or retinoids (HR, 1.80; 95% CI, 1.03-2.96). Any biological drug use had a comparable but nonsignificant reduction of cardiovascular events (HR, 0.58; 95% CI, 0.30-1.10). After multivariable adjustment, TNF inhibitors were associated with a statistically significant decreased risk for cardiovascular events (HR, 0.46; 95% CI, 0.22-0.98; P=.04) compared to nonsystemic therapies. The IL-12/23 inhibitor did not demonstrate this relationship (HR, 1.52; 95% CI, 0.47-4.94).6

Lastly, Wu et al7 compared the risk for MACE (ie, myocardial infarction, stroke, unstable angina, transient ischemic attack) between patients with psoriasis who received TNF inhibitors or methotrexate. The TNF inhibitor and methotrexate cohorts were observed for a median of 12 months and 9 months, respectively. After adjusting for potential confounding factors, they found a 45% reduction (HR, 0.55; 95% CI, 0.45-0.67) in cardiovascular event risk in the TNF inhibitor cohort compared with the methotrexate cohort. Notably, analyses also showed comparatively fewer cardiovascular events in the TNF inhibitor cohort throughout all time points—6, 12, 18, 24, 60 months—in the observation period. Regression analysis revealed an 11% reduction in cardiovascular events (HR, 0.89; 95% CI, 0.80-0.98) with each additional 6 months of cumulative TNF inhibitor exposure.

The current sum of evidence suggests cardioprotective effects of TNF inhibitor and methotrexate use. However, given the cumulative systemic toxicity and inferior cutaneous efficacy of methotrexate, TNF inhibitors will likely play a more significant role going forward. The role of methotrexate may be for its simultaneous use with biologic therapies to limit immunogenicity. Newer biologic agents such as IL-12/23 and IL-17 inhibitors have not yet been as extensively studied for their effects on cardiovascular risk as their TNF inhibitor counterparts. However, because of their shared ability to target specific immunological pathways, it is plausible that IL-12/23 and IL-17 agents may exhibit cardioprotective effects.8

Patients with psoriasis should be counseled and educated about the increased risk for CVD and its associated morbidity and mortality risk. Screening for modifiable risk factors and recommending therapeutic lifestyle changes also is appropriate. Future studies should help define the role of specific systemic drugs in reducing the risk for CVD in patients with psoriasis. Despite the expanding amount of evidence in the current literature implicating the use of TNF inhibitors for cardiovascular risk prevention, there is still a need for long-term, randomized, placebo-controlled trials to provide more authoritative evidence-based recommendations.

 

 

References
  1. Gkalpakiotis S, Arenbergerova M, Gkalpakioti P, et al. Impact of adalimumab treatment on cardiovascular risk biomarkers in psoriasis: results of a pilot study [published online October 24, 2016]. J Dermatol. doi:10.1111/1346-8138.13661.
  2. Wu JJ, Rowan CG, Bebchuk JD, et al. Association between tumor necrosis factor inhibitor (TNFi) therapy and changes in C-reactive protein (CRP), blood pressure, and alanine aminotransferase (ALT) among patients with psoriasis, psoriatic arthritis, or rheumatoid arthritis [published online March 5, 2015]. J Am Acad Dermatol. 2015;72:917-919.
  3. Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
  4. Pina T, Corrales A, Lopez-Mejias R, et al. Anti-tumor necrosis factor-alpha therapy improves endothelial function and arterial stiffness in patients with moderate to severe psoriasis: a 6-month prospective study. J Dermatol. 2016;43:1267-1272.
  5. Ahlehoff O, Hansen PR, Gislason GH, et al. Myocardial function and effects of biologic therapy in patients with severe psoriasis: a prospective echocardiographic study [published online April 6, 2015]. J Eur Acad Dermatol Venereol. 2016;30:819-823.
  6. Ahlehoff O, Skov L, Gislason G, et al. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis: 5-year follow-up of a Danish nationwide cohort [published online October 10, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1128-1134.
  7. Wu JJ, Guérin A, Sundaram M, et al. Cardiovascular event risk assessment in psoriasis patients treated with tumor necrosis factor-α inhibitors versus methotrexate [published online October 26, 2016]. J Am Acad Dermatol. 2017;76:81-90.
  8. Egeberg A, Skov L. Management of cardiovascular disease in patients with psoriasis. Expert Opin Pharmacother. 2016;17:1509-1516.
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Author and Disclosure Information

Mr. No is from the School of Medicine, Loma Linda University, California. Ms. Amin is from the School of Medicine, University of California, Riverside. Dr. Egeberg is from the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Denmark. Dr. Wu is from the Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, California.

Mr. No and Ms. Amin report no conflict of interest. Dr. Egeberg has received research funding from Eli Lilly and Company and Pfizer Inc and honoraria as consultant and/or speaker from Eli Lilly and Company; Galderma Laboratories, LP; Janssen; Novartis; and Pfizer Inc. Dr. Wu has received research funding from AbbVie Inc; Amgen Inc; AstraZeneca; Boehringer Ingelheim; Coherus BioSciences Inc; Dermira Inc; Eli Lilly and Company; Janssen; Merck & Co, Inc; Novartis; Pfizer Inc; Regeneron Pharmaceuticals, Inc; Sandoz, A Novartis Division; and Sun Pharmaceutical Industries Ltd. He also is a consultant for AbbVie Inc; Amgen Inc; AstraZeneca; Celgene Corporation; Dermira Inc; Eli Lilly and Company; LEO Pharma; Pfizer Inc; Regeneron Pharmaceuticals, Inc; Sun Pharmaceutical Industries Ltd; and Valeant Pharmaceuticals International, Inc. All funds go to his employer.

Correspondence: Jashin J. Wu, MD, Kaiser Permanente Los Angeles Medical Center, Department of Dermatology, 1515 N Vermont Ave, 5th Floor, Los Angeles, CA 90027 ([email protected]).

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Mr. No is from the School of Medicine, Loma Linda University, California. Ms. Amin is from the School of Medicine, University of California, Riverside. Dr. Egeberg is from the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Denmark. Dr. Wu is from the Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, California.

Mr. No and Ms. Amin report no conflict of interest. Dr. Egeberg has received research funding from Eli Lilly and Company and Pfizer Inc and honoraria as consultant and/or speaker from Eli Lilly and Company; Galderma Laboratories, LP; Janssen; Novartis; and Pfizer Inc. Dr. Wu has received research funding from AbbVie Inc; Amgen Inc; AstraZeneca; Boehringer Ingelheim; Coherus BioSciences Inc; Dermira Inc; Eli Lilly and Company; Janssen; Merck & Co, Inc; Novartis; Pfizer Inc; Regeneron Pharmaceuticals, Inc; Sandoz, A Novartis Division; and Sun Pharmaceutical Industries Ltd. He also is a consultant for AbbVie Inc; Amgen Inc; AstraZeneca; Celgene Corporation; Dermira Inc; Eli Lilly and Company; LEO Pharma; Pfizer Inc; Regeneron Pharmaceuticals, Inc; Sun Pharmaceutical Industries Ltd; and Valeant Pharmaceuticals International, Inc. All funds go to his employer.

Correspondence: Jashin J. Wu, MD, Kaiser Permanente Los Angeles Medical Center, Department of Dermatology, 1515 N Vermont Ave, 5th Floor, Los Angeles, CA 90027 ([email protected]).

Author and Disclosure Information

Mr. No is from the School of Medicine, Loma Linda University, California. Ms. Amin is from the School of Medicine, University of California, Riverside. Dr. Egeberg is from the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Denmark. Dr. Wu is from the Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, California.

Mr. No and Ms. Amin report no conflict of interest. Dr. Egeberg has received research funding from Eli Lilly and Company and Pfizer Inc and honoraria as consultant and/or speaker from Eli Lilly and Company; Galderma Laboratories, LP; Janssen; Novartis; and Pfizer Inc. Dr. Wu has received research funding from AbbVie Inc; Amgen Inc; AstraZeneca; Boehringer Ingelheim; Coherus BioSciences Inc; Dermira Inc; Eli Lilly and Company; Janssen; Merck & Co, Inc; Novartis; Pfizer Inc; Regeneron Pharmaceuticals, Inc; Sandoz, A Novartis Division; and Sun Pharmaceutical Industries Ltd. He also is a consultant for AbbVie Inc; Amgen Inc; AstraZeneca; Celgene Corporation; Dermira Inc; Eli Lilly and Company; LEO Pharma; Pfizer Inc; Regeneron Pharmaceuticals, Inc; Sun Pharmaceutical Industries Ltd; and Valeant Pharmaceuticals International, Inc. All funds go to his employer.

Correspondence: Jashin J. Wu, MD, Kaiser Permanente Los Angeles Medical Center, Department of Dermatology, 1515 N Vermont Ave, 5th Floor, Los Angeles, CA 90027 ([email protected]).

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The cardiovascular comorbidities associated with psoriasis have been well documented; however, the mechanism by which psoriasis increases the risk for cardiovascular disease (CVD) remains unclear. Elevated systemic inflammatory cytokines and mediators may play a key role in their association, which prompts the questions: Do systemic medications have a protective effect? Do patients on systemic antipsoriatic treatment have a decreased risk for major adverse cardiovascular events (MACEs) compared with untreated patients?

We believe the shared inflammatory processes involved in psoriasis and atherosclerosis formation are potential targets for therapy in reducing the incidence of CVD and its associated complications. A growing amount of evidence suggests cardioprotective effects associated with antipsoriatic treatments such as tumor necrosis factor (TNF) inhibitors and methotrexate. Gkalpakiotis et al1 demonstrated a reduction in serum E-selectin (mean [standard deviation], 53.04 [23.54] ng/mL vs 35.32 [8.70] ng/mL; P<.001) and IL-22 (25.11 [19.9] pg/mL vs 12.83 [8.42] pg/mL; P<.001) after 3 months of adalimumab administration in patients with moderate to severe psoriasis. Both E-selectin and IL-22 are associated with the development of atherosclerosis, endothelial dysfunction, and an increased incidence of CVD. Similarly, Wu et al2 demonstrated a statistically significant reduction (5.04 mg/dL [95% confidence interval [CI], 8.24 to 2.12; P<.01) in C-reactive protein in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis after concurrent use of methotrexate and TNF inhibitors.

Solomon et al3 compared the rate of newly diagnosed diabetes mellitus among psoriasis and rheumatoid arthritis patients treated with TNF inhibitors, methotrexate, hydroxychloroquine, and other nonbiologic disease-modifying antirheumatic drugs. The authors’ findings suggest that those who take a TNF inhibitor (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80) are at lower risk for diabetes mellitus compared to those treated with nonbiologic disease-modifying antirheumatic drugs. Conversely, the methotrexate (HR, 0.77; 95% CI, 0.53-1.13) cohort did not show a statistically significant reduction in diabetes risk.3

Pina et al4 revealed improvement in endothelial function after 6 months of adalimumab use in patients with moderate to severe psoriasis. To evaluate the presence of subclinical endothelial dysfunction, the authors assessed brachial artery reactivity by measuring flow-mediated dilation and carotid artery stiffness by pulse wave velocity. Patients showed an increase in flow-mediated dilation (mean [SD], 6.19% [2.44%] vs 7.46% [2.43%]; P=.008) and reduction in pulse wave velocity (6.28 [1.04] m/s vs 5.69 [1.31] m/s; P=.03) compared to baseline measurements, indicating an improvement of endothelial function.4

Ahlehoff et al5 observed for improvements in subclinical left ventricular dysfunction in psoriasis patients after treatment with biologics. Using echocardiography, they assessed for changes in diastolic function and left ventricular systolic deformation (defined by global longitudinal strain). Of patients who received 3 months of biologic therapy (TNF inhibitor orIL-12/23 inhibitor) and maintained at minimum a psoriasis area and severity index 50 response, all demonstrated an improvement in diastolic function (mean [SD], 8.1 [2.1] vs 6.7 [1.9]; P<.001) and global longitudinal strain (mean [SD], 16.8% [2.1%] vs 18.3% [2.3%]; P<.001). Of note, patients who did not achieve a psoriasis area and severity index 50 response at follow-up did not exhibit an improvement in subclinical myocardial function.5

Moreover, a Danish nationwide study with up to 5-year follow-up evaluated the risk for MACE (ie, cardiovascular death, myocardial infarction, stroke) in patients with severe psoriasis receiving systemic anti-inflammatory medications and nonsystemic therapies including topical treatments, phototherapy, and climate therapy.6 Compared to nonsystemic therapies, methotrexate use (HR, 0.53; 95% CI, 0.34-0.83) was associated with a decreased risk for cardiovascular events. However, a protective decreased risk was not found among patients who used systemic cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) or retinoids (HR, 1.80; 95% CI, 1.03-2.96). Any biological drug use had a comparable but nonsignificant reduction of cardiovascular events (HR, 0.58; 95% CI, 0.30-1.10). After multivariable adjustment, TNF inhibitors were associated with a statistically significant decreased risk for cardiovascular events (HR, 0.46; 95% CI, 0.22-0.98; P=.04) compared to nonsystemic therapies. The IL-12/23 inhibitor did not demonstrate this relationship (HR, 1.52; 95% CI, 0.47-4.94).6

Lastly, Wu et al7 compared the risk for MACE (ie, myocardial infarction, stroke, unstable angina, transient ischemic attack) between patients with psoriasis who received TNF inhibitors or methotrexate. The TNF inhibitor and methotrexate cohorts were observed for a median of 12 months and 9 months, respectively. After adjusting for potential confounding factors, they found a 45% reduction (HR, 0.55; 95% CI, 0.45-0.67) in cardiovascular event risk in the TNF inhibitor cohort compared with the methotrexate cohort. Notably, analyses also showed comparatively fewer cardiovascular events in the TNF inhibitor cohort throughout all time points—6, 12, 18, 24, 60 months—in the observation period. Regression analysis revealed an 11% reduction in cardiovascular events (HR, 0.89; 95% CI, 0.80-0.98) with each additional 6 months of cumulative TNF inhibitor exposure.

The current sum of evidence suggests cardioprotective effects of TNF inhibitor and methotrexate use. However, given the cumulative systemic toxicity and inferior cutaneous efficacy of methotrexate, TNF inhibitors will likely play a more significant role going forward. The role of methotrexate may be for its simultaneous use with biologic therapies to limit immunogenicity. Newer biologic agents such as IL-12/23 and IL-17 inhibitors have not yet been as extensively studied for their effects on cardiovascular risk as their TNF inhibitor counterparts. However, because of their shared ability to target specific immunological pathways, it is plausible that IL-12/23 and IL-17 agents may exhibit cardioprotective effects.8

Patients with psoriasis should be counseled and educated about the increased risk for CVD and its associated morbidity and mortality risk. Screening for modifiable risk factors and recommending therapeutic lifestyle changes also is appropriate. Future studies should help define the role of specific systemic drugs in reducing the risk for CVD in patients with psoriasis. Despite the expanding amount of evidence in the current literature implicating the use of TNF inhibitors for cardiovascular risk prevention, there is still a need for long-term, randomized, placebo-controlled trials to provide more authoritative evidence-based recommendations.

 

 

The cardiovascular comorbidities associated with psoriasis have been well documented; however, the mechanism by which psoriasis increases the risk for cardiovascular disease (CVD) remains unclear. Elevated systemic inflammatory cytokines and mediators may play a key role in their association, which prompts the questions: Do systemic medications have a protective effect? Do patients on systemic antipsoriatic treatment have a decreased risk for major adverse cardiovascular events (MACEs) compared with untreated patients?

We believe the shared inflammatory processes involved in psoriasis and atherosclerosis formation are potential targets for therapy in reducing the incidence of CVD and its associated complications. A growing amount of evidence suggests cardioprotective effects associated with antipsoriatic treatments such as tumor necrosis factor (TNF) inhibitors and methotrexate. Gkalpakiotis et al1 demonstrated a reduction in serum E-selectin (mean [standard deviation], 53.04 [23.54] ng/mL vs 35.32 [8.70] ng/mL; P<.001) and IL-22 (25.11 [19.9] pg/mL vs 12.83 [8.42] pg/mL; P<.001) after 3 months of adalimumab administration in patients with moderate to severe psoriasis. Both E-selectin and IL-22 are associated with the development of atherosclerosis, endothelial dysfunction, and an increased incidence of CVD. Similarly, Wu et al2 demonstrated a statistically significant reduction (5.04 mg/dL [95% confidence interval [CI], 8.24 to 2.12; P<.01) in C-reactive protein in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis after concurrent use of methotrexate and TNF inhibitors.

Solomon et al3 compared the rate of newly diagnosed diabetes mellitus among psoriasis and rheumatoid arthritis patients treated with TNF inhibitors, methotrexate, hydroxychloroquine, and other nonbiologic disease-modifying antirheumatic drugs. The authors’ findings suggest that those who take a TNF inhibitor (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80) are at lower risk for diabetes mellitus compared to those treated with nonbiologic disease-modifying antirheumatic drugs. Conversely, the methotrexate (HR, 0.77; 95% CI, 0.53-1.13) cohort did not show a statistically significant reduction in diabetes risk.3

Pina et al4 revealed improvement in endothelial function after 6 months of adalimumab use in patients with moderate to severe psoriasis. To evaluate the presence of subclinical endothelial dysfunction, the authors assessed brachial artery reactivity by measuring flow-mediated dilation and carotid artery stiffness by pulse wave velocity. Patients showed an increase in flow-mediated dilation (mean [SD], 6.19% [2.44%] vs 7.46% [2.43%]; P=.008) and reduction in pulse wave velocity (6.28 [1.04] m/s vs 5.69 [1.31] m/s; P=.03) compared to baseline measurements, indicating an improvement of endothelial function.4

Ahlehoff et al5 observed for improvements in subclinical left ventricular dysfunction in psoriasis patients after treatment with biologics. Using echocardiography, they assessed for changes in diastolic function and left ventricular systolic deformation (defined by global longitudinal strain). Of patients who received 3 months of biologic therapy (TNF inhibitor orIL-12/23 inhibitor) and maintained at minimum a psoriasis area and severity index 50 response, all demonstrated an improvement in diastolic function (mean [SD], 8.1 [2.1] vs 6.7 [1.9]; P<.001) and global longitudinal strain (mean [SD], 16.8% [2.1%] vs 18.3% [2.3%]; P<.001). Of note, patients who did not achieve a psoriasis area and severity index 50 response at follow-up did not exhibit an improvement in subclinical myocardial function.5

Moreover, a Danish nationwide study with up to 5-year follow-up evaluated the risk for MACE (ie, cardiovascular death, myocardial infarction, stroke) in patients with severe psoriasis receiving systemic anti-inflammatory medications and nonsystemic therapies including topical treatments, phototherapy, and climate therapy.6 Compared to nonsystemic therapies, methotrexate use (HR, 0.53; 95% CI, 0.34-0.83) was associated with a decreased risk for cardiovascular events. However, a protective decreased risk was not found among patients who used systemic cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) or retinoids (HR, 1.80; 95% CI, 1.03-2.96). Any biological drug use had a comparable but nonsignificant reduction of cardiovascular events (HR, 0.58; 95% CI, 0.30-1.10). After multivariable adjustment, TNF inhibitors were associated with a statistically significant decreased risk for cardiovascular events (HR, 0.46; 95% CI, 0.22-0.98; P=.04) compared to nonsystemic therapies. The IL-12/23 inhibitor did not demonstrate this relationship (HR, 1.52; 95% CI, 0.47-4.94).6

Lastly, Wu et al7 compared the risk for MACE (ie, myocardial infarction, stroke, unstable angina, transient ischemic attack) between patients with psoriasis who received TNF inhibitors or methotrexate. The TNF inhibitor and methotrexate cohorts were observed for a median of 12 months and 9 months, respectively. After adjusting for potential confounding factors, they found a 45% reduction (HR, 0.55; 95% CI, 0.45-0.67) in cardiovascular event risk in the TNF inhibitor cohort compared with the methotrexate cohort. Notably, analyses also showed comparatively fewer cardiovascular events in the TNF inhibitor cohort throughout all time points—6, 12, 18, 24, 60 months—in the observation period. Regression analysis revealed an 11% reduction in cardiovascular events (HR, 0.89; 95% CI, 0.80-0.98) with each additional 6 months of cumulative TNF inhibitor exposure.

The current sum of evidence suggests cardioprotective effects of TNF inhibitor and methotrexate use. However, given the cumulative systemic toxicity and inferior cutaneous efficacy of methotrexate, TNF inhibitors will likely play a more significant role going forward. The role of methotrexate may be for its simultaneous use with biologic therapies to limit immunogenicity. Newer biologic agents such as IL-12/23 and IL-17 inhibitors have not yet been as extensively studied for their effects on cardiovascular risk as their TNF inhibitor counterparts. However, because of their shared ability to target specific immunological pathways, it is plausible that IL-12/23 and IL-17 agents may exhibit cardioprotective effects.8

Patients with psoriasis should be counseled and educated about the increased risk for CVD and its associated morbidity and mortality risk. Screening for modifiable risk factors and recommending therapeutic lifestyle changes also is appropriate. Future studies should help define the role of specific systemic drugs in reducing the risk for CVD in patients with psoriasis. Despite the expanding amount of evidence in the current literature implicating the use of TNF inhibitors for cardiovascular risk prevention, there is still a need for long-term, randomized, placebo-controlled trials to provide more authoritative evidence-based recommendations.

 

 

References
  1. Gkalpakiotis S, Arenbergerova M, Gkalpakioti P, et al. Impact of adalimumab treatment on cardiovascular risk biomarkers in psoriasis: results of a pilot study [published online October 24, 2016]. J Dermatol. doi:10.1111/1346-8138.13661.
  2. Wu JJ, Rowan CG, Bebchuk JD, et al. Association between tumor necrosis factor inhibitor (TNFi) therapy and changes in C-reactive protein (CRP), blood pressure, and alanine aminotransferase (ALT) among patients with psoriasis, psoriatic arthritis, or rheumatoid arthritis [published online March 5, 2015]. J Am Acad Dermatol. 2015;72:917-919.
  3. Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
  4. Pina T, Corrales A, Lopez-Mejias R, et al. Anti-tumor necrosis factor-alpha therapy improves endothelial function and arterial stiffness in patients with moderate to severe psoriasis: a 6-month prospective study. J Dermatol. 2016;43:1267-1272.
  5. Ahlehoff O, Hansen PR, Gislason GH, et al. Myocardial function and effects of biologic therapy in patients with severe psoriasis: a prospective echocardiographic study [published online April 6, 2015]. J Eur Acad Dermatol Venereol. 2016;30:819-823.
  6. Ahlehoff O, Skov L, Gislason G, et al. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis: 5-year follow-up of a Danish nationwide cohort [published online October 10, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1128-1134.
  7. Wu JJ, Guérin A, Sundaram M, et al. Cardiovascular event risk assessment in psoriasis patients treated with tumor necrosis factor-α inhibitors versus methotrexate [published online October 26, 2016]. J Am Acad Dermatol. 2017;76:81-90.
  8. Egeberg A, Skov L. Management of cardiovascular disease in patients with psoriasis. Expert Opin Pharmacother. 2016;17:1509-1516.
References
  1. Gkalpakiotis S, Arenbergerova M, Gkalpakioti P, et al. Impact of adalimumab treatment on cardiovascular risk biomarkers in psoriasis: results of a pilot study [published online October 24, 2016]. J Dermatol. doi:10.1111/1346-8138.13661.
  2. Wu JJ, Rowan CG, Bebchuk JD, et al. Association between tumor necrosis factor inhibitor (TNFi) therapy and changes in C-reactive protein (CRP), blood pressure, and alanine aminotransferase (ALT) among patients with psoriasis, psoriatic arthritis, or rheumatoid arthritis [published online March 5, 2015]. J Am Acad Dermatol. 2015;72:917-919.
  3. Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
  4. Pina T, Corrales A, Lopez-Mejias R, et al. Anti-tumor necrosis factor-alpha therapy improves endothelial function and arterial stiffness in patients with moderate to severe psoriasis: a 6-month prospective study. J Dermatol. 2016;43:1267-1272.
  5. Ahlehoff O, Hansen PR, Gislason GH, et al. Myocardial function and effects of biologic therapy in patients with severe psoriasis: a prospective echocardiographic study [published online April 6, 2015]. J Eur Acad Dermatol Venereol. 2016;30:819-823.
  6. Ahlehoff O, Skov L, Gislason G, et al. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis: 5-year follow-up of a Danish nationwide cohort [published online October 10, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1128-1134.
  7. Wu JJ, Guérin A, Sundaram M, et al. Cardiovascular event risk assessment in psoriasis patients treated with tumor necrosis factor-α inhibitors versus methotrexate [published online October 26, 2016]. J Am Acad Dermatol. 2017;76:81-90.
  8. Egeberg A, Skov L. Management of cardiovascular disease in patients with psoriasis. Expert Opin Pharmacother. 2016;17:1509-1516.
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Ovarian cancer screening update

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Fri, 01/18/2019 - 16:27

Ovarian cancer remains the most deadly gynecologic malignancy in the United States with more than 14,000 deaths in 2016. Yet, the prevalence remains low with approximately 22,000 cases in 2016. Stage at diagnosis is one of the strongest predictors of overall survival. The 5-year overall survival is more than 90% with stage I disease; this drops to 25% for those with distant metastases. Unfortunately, three-quarters of patients have disease spread beyond the ovary at the time ovarian cancer is clinically identified.

In this update, we will review:

• The fundamentals of ovarian cancer screening.

• How to identify patients who would benefit from surveillance.

• The usefulness of tumor markers.

• The results from recent large ovarian cancer screening trials.

Screening is a critical part of secondary prevention through early disease detection, when patients are asymptomatic and treatment can stop progression. Core principles of a good screening test are that the test is noninvasive, tolerable to the patient, and not costly. The disease should pose a major health threat and be detected at a stage at which intervention can impart a survival advantage. Most critically, the test should be sensitive and specific (i.e., detect disease when it is truly present and rarely be positive in the absence of disease).

Dr. Emma C. Rossi
The likelihood that a screening test accurately diagnoses the disease is referred to as the positive or negative predictive value. For example, the positive predictive value refers to the probability that a patient has ovarian cancer when the test is positive. These predictive values rely strongly on the prevalence of the disease in the test population. Herein lies the major challenge with ovarian cancer screening: The average lifetime risk of developing ovarian cancer is low, approximately 1 in 70. Even a clinical test with 100% sensitivity and 99% specificity would have a positive predictive value of just 4.8%.1.

Dr. Stuart R. Pierce
A further challenge for ovarian cancer screening is that the confirmatory test requires a major surgical procedure – oophorectomy or ovarian cystectomy – with its own potential risk and harm. Currently, all North American expert groups, including the U.S. Preventive Services Task Force and the Society of Gynecologic Oncology, recommend against screening patients who are at average risk for ovarian cancer.

Screening vs. case finding

A significant distinction should be made between average-risk patients and high-risk patients. Ob.gyns. frequently encounter high-risk patients who would benefit from regular surveillance or case finding (for example, patients with BRCA deleterious mutations or with Lynch syndrome). There are multiple risk factors for ovarian cancer, but the strongest known is family history, which is present in 15% of ovarian cancer patients. Having one relative with ovarian cancer increases the lifetime risk of ovarian cancer up to 5%. When a patient reports having one or more family members with ovarian cancer, it is important to differentiate between a common sporadic presentation and a rare familial cancer syndrome. ACOG Practice Bulletin 103 provides excellent guidance on which patients warrant formal genetic risk assessments by a genetic counselor.2

Tumor markers

During the last 25 years, screening for ovarian cancer in an average-risk population has been evaluated in multiple large prospective studies using serum tumor markers (i.e., CA 125) and ultrasound results.

CA 125 and HE4 tumor markers are frequently elevated in ovarian cancer and have been studied in ovarian cancer screening. However, while having a high sensitivity for detecting disease, they are nonspecific because they are also elevated in numerous benign conditions and therefore have not proven to be a useful screening tool in the average-risk population. There are clinically available tumor marker panels that are not intended for screening. Rather, they clarify the uncertainty of the presurgical adnexal mass evaluation by providing a risk score. High risk scores are generally managed in conjunction with a gynecologic oncology referral.

Multimodal screening

Combined assessment of both ultrasound findings and tumor marker levels shows more promise with respect to prediction of ovarian cancer. However, a systematic review of 25 ovarian cancer screening studies concluded that screening low-risk populations should not be included in clinical practice until randomized trials assessed the effect on mortality and the risk of adverse events. Three large randomized controlled trials have been completed to date.3,4,5

The U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) results appear promising. However, the revealing analysis was post hoc since the original study design did not take into account the inherent delayed effect in screening studies. While these results may provide a basis for future successful screening for ovarian cancer, confirmatory further analysis is pending, using additional data over a period of the next 3 years.

Ultimately, we are all excited about the possibility of effective screening protocols for ovarian cancer and await completed analyses of UKCTOCS. Until their benefits are confirmed, screening and preventive measures should be limited to those at high risk for ovarian cancer.

 

 

References

1. Hippokratia. 2007 Apr;11(2):63-6.

2. Obstet Gynecol. 2009 Apr;113(4):957-66.

3. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9.

4. Int J Gynecol Cancer. 2008 May-Jun;18(3):414-20.

5. Lancet. 2016 Mar 5;387(10022):945-56.

Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no relevant financial disclosures.

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Ovarian cancer remains the most deadly gynecologic malignancy in the United States with more than 14,000 deaths in 2016. Yet, the prevalence remains low with approximately 22,000 cases in 2016. Stage at diagnosis is one of the strongest predictors of overall survival. The 5-year overall survival is more than 90% with stage I disease; this drops to 25% for those with distant metastases. Unfortunately, three-quarters of patients have disease spread beyond the ovary at the time ovarian cancer is clinically identified.

In this update, we will review:

• The fundamentals of ovarian cancer screening.

• How to identify patients who would benefit from surveillance.

• The usefulness of tumor markers.

• The results from recent large ovarian cancer screening trials.

Screening is a critical part of secondary prevention through early disease detection, when patients are asymptomatic and treatment can stop progression. Core principles of a good screening test are that the test is noninvasive, tolerable to the patient, and not costly. The disease should pose a major health threat and be detected at a stage at which intervention can impart a survival advantage. Most critically, the test should be sensitive and specific (i.e., detect disease when it is truly present and rarely be positive in the absence of disease).

Dr. Emma C. Rossi
The likelihood that a screening test accurately diagnoses the disease is referred to as the positive or negative predictive value. For example, the positive predictive value refers to the probability that a patient has ovarian cancer when the test is positive. These predictive values rely strongly on the prevalence of the disease in the test population. Herein lies the major challenge with ovarian cancer screening: The average lifetime risk of developing ovarian cancer is low, approximately 1 in 70. Even a clinical test with 100% sensitivity and 99% specificity would have a positive predictive value of just 4.8%.1.

Dr. Stuart R. Pierce
A further challenge for ovarian cancer screening is that the confirmatory test requires a major surgical procedure – oophorectomy or ovarian cystectomy – with its own potential risk and harm. Currently, all North American expert groups, including the U.S. Preventive Services Task Force and the Society of Gynecologic Oncology, recommend against screening patients who are at average risk for ovarian cancer.

Screening vs. case finding

A significant distinction should be made between average-risk patients and high-risk patients. Ob.gyns. frequently encounter high-risk patients who would benefit from regular surveillance or case finding (for example, patients with BRCA deleterious mutations or with Lynch syndrome). There are multiple risk factors for ovarian cancer, but the strongest known is family history, which is present in 15% of ovarian cancer patients. Having one relative with ovarian cancer increases the lifetime risk of ovarian cancer up to 5%. When a patient reports having one or more family members with ovarian cancer, it is important to differentiate between a common sporadic presentation and a rare familial cancer syndrome. ACOG Practice Bulletin 103 provides excellent guidance on which patients warrant formal genetic risk assessments by a genetic counselor.2

Tumor markers

During the last 25 years, screening for ovarian cancer in an average-risk population has been evaluated in multiple large prospective studies using serum tumor markers (i.e., CA 125) and ultrasound results.

CA 125 and HE4 tumor markers are frequently elevated in ovarian cancer and have been studied in ovarian cancer screening. However, while having a high sensitivity for detecting disease, they are nonspecific because they are also elevated in numerous benign conditions and therefore have not proven to be a useful screening tool in the average-risk population. There are clinically available tumor marker panels that are not intended for screening. Rather, they clarify the uncertainty of the presurgical adnexal mass evaluation by providing a risk score. High risk scores are generally managed in conjunction with a gynecologic oncology referral.

Multimodal screening

Combined assessment of both ultrasound findings and tumor marker levels shows more promise with respect to prediction of ovarian cancer. However, a systematic review of 25 ovarian cancer screening studies concluded that screening low-risk populations should not be included in clinical practice until randomized trials assessed the effect on mortality and the risk of adverse events. Three large randomized controlled trials have been completed to date.3,4,5

The U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) results appear promising. However, the revealing analysis was post hoc since the original study design did not take into account the inherent delayed effect in screening studies. While these results may provide a basis for future successful screening for ovarian cancer, confirmatory further analysis is pending, using additional data over a period of the next 3 years.

Ultimately, we are all excited about the possibility of effective screening protocols for ovarian cancer and await completed analyses of UKCTOCS. Until their benefits are confirmed, screening and preventive measures should be limited to those at high risk for ovarian cancer.

 

 

References

1. Hippokratia. 2007 Apr;11(2):63-6.

2. Obstet Gynecol. 2009 Apr;113(4):957-66.

3. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9.

4. Int J Gynecol Cancer. 2008 May-Jun;18(3):414-20.

5. Lancet. 2016 Mar 5;387(10022):945-56.

Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no relevant financial disclosures.

Ovarian cancer remains the most deadly gynecologic malignancy in the United States with more than 14,000 deaths in 2016. Yet, the prevalence remains low with approximately 22,000 cases in 2016. Stage at diagnosis is one of the strongest predictors of overall survival. The 5-year overall survival is more than 90% with stage I disease; this drops to 25% for those with distant metastases. Unfortunately, three-quarters of patients have disease spread beyond the ovary at the time ovarian cancer is clinically identified.

In this update, we will review:

• The fundamentals of ovarian cancer screening.

• How to identify patients who would benefit from surveillance.

• The usefulness of tumor markers.

• The results from recent large ovarian cancer screening trials.

Screening is a critical part of secondary prevention through early disease detection, when patients are asymptomatic and treatment can stop progression. Core principles of a good screening test are that the test is noninvasive, tolerable to the patient, and not costly. The disease should pose a major health threat and be detected at a stage at which intervention can impart a survival advantage. Most critically, the test should be sensitive and specific (i.e., detect disease when it is truly present and rarely be positive in the absence of disease).

Dr. Emma C. Rossi
The likelihood that a screening test accurately diagnoses the disease is referred to as the positive or negative predictive value. For example, the positive predictive value refers to the probability that a patient has ovarian cancer when the test is positive. These predictive values rely strongly on the prevalence of the disease in the test population. Herein lies the major challenge with ovarian cancer screening: The average lifetime risk of developing ovarian cancer is low, approximately 1 in 70. Even a clinical test with 100% sensitivity and 99% specificity would have a positive predictive value of just 4.8%.1.

Dr. Stuart R. Pierce
A further challenge for ovarian cancer screening is that the confirmatory test requires a major surgical procedure – oophorectomy or ovarian cystectomy – with its own potential risk and harm. Currently, all North American expert groups, including the U.S. Preventive Services Task Force and the Society of Gynecologic Oncology, recommend against screening patients who are at average risk for ovarian cancer.

Screening vs. case finding

A significant distinction should be made between average-risk patients and high-risk patients. Ob.gyns. frequently encounter high-risk patients who would benefit from regular surveillance or case finding (for example, patients with BRCA deleterious mutations or with Lynch syndrome). There are multiple risk factors for ovarian cancer, but the strongest known is family history, which is present in 15% of ovarian cancer patients. Having one relative with ovarian cancer increases the lifetime risk of ovarian cancer up to 5%. When a patient reports having one or more family members with ovarian cancer, it is important to differentiate between a common sporadic presentation and a rare familial cancer syndrome. ACOG Practice Bulletin 103 provides excellent guidance on which patients warrant formal genetic risk assessments by a genetic counselor.2

Tumor markers

During the last 25 years, screening for ovarian cancer in an average-risk population has been evaluated in multiple large prospective studies using serum tumor markers (i.e., CA 125) and ultrasound results.

CA 125 and HE4 tumor markers are frequently elevated in ovarian cancer and have been studied in ovarian cancer screening. However, while having a high sensitivity for detecting disease, they are nonspecific because they are also elevated in numerous benign conditions and therefore have not proven to be a useful screening tool in the average-risk population. There are clinically available tumor marker panels that are not intended for screening. Rather, they clarify the uncertainty of the presurgical adnexal mass evaluation by providing a risk score. High risk scores are generally managed in conjunction with a gynecologic oncology referral.

Multimodal screening

Combined assessment of both ultrasound findings and tumor marker levels shows more promise with respect to prediction of ovarian cancer. However, a systematic review of 25 ovarian cancer screening studies concluded that screening low-risk populations should not be included in clinical practice until randomized trials assessed the effect on mortality and the risk of adverse events. Three large randomized controlled trials have been completed to date.3,4,5

The U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) results appear promising. However, the revealing analysis was post hoc since the original study design did not take into account the inherent delayed effect in screening studies. While these results may provide a basis for future successful screening for ovarian cancer, confirmatory further analysis is pending, using additional data over a period of the next 3 years.

Ultimately, we are all excited about the possibility of effective screening protocols for ovarian cancer and await completed analyses of UKCTOCS. Until their benefits are confirmed, screening and preventive measures should be limited to those at high risk for ovarian cancer.

 

 

References

1. Hippokratia. 2007 Apr;11(2):63-6.

2. Obstet Gynecol. 2009 Apr;113(4):957-66.

3. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9.

4. Int J Gynecol Cancer. 2008 May-Jun;18(3):414-20.

5. Lancet. 2016 Mar 5;387(10022):945-56.

Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no relevant financial disclosures.

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Putting the “PA” in “FPA”

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Putting the “PA” in “FPA”
 

The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.1 Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.2 In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.5 Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.6

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.7 Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”8 Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.9 But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.10 Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.11

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.12 This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.13

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.14 And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.15 This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.16

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

References

1. American Association of Nurse Practitioners. Issues at-a glance: full practice authority. www.aanp.org/aanpqa2/images/documents/policy-toolbox/fullpracticeauthority.pdf. Accessed January 9, 2017.
2. ECRI Institute. Scope of practice laws for nurse practitioners and physician assistants. www.ecri.org/components/PPRM/Pages/LB5.aspx. Accessed January 9, 2017.
3. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2010/The-Future-of-Nursing/Future%20of%20Nursing%202010%20Recommendations.pdf. Accessed January 9, 2017.
4. National Governors Association. The role of nurse practitioners in meeting increasing demand for primary care. www.nga.org/cms/home/nga-center-for-best-practices/center-publications/page-health-publications/col2-content/main-content-list/the-role-of-nurse-practitioners.html. Accessed January 9, 2017.
5. Martsolf GR, Auerbach DI, Arifkhanova A. The impact of full practice authority for nurse practitioners and other advanced practice registered nurses in Ohio. www.rand.org/content/dam/rand/pubs/research_reports/RR800/RR848/RAND_RR848.pdf. Accessed January 9, 2017.
6. Gilman DJ, Koslov TI. Policy perspectives: competition advocacy and the regulation of advanced practice nurses. www.aacn.nche.edu/government-affairs/APRN-Policy-Paper.pdf. Accessed January 9, 2017.
7. American Academy of Family Physicians. AAFP, others protest VA’s attempt to expand APRNs’ scope of practice. www.aafp.org/news/government-medicine/20131122valetteraprn.html. Accessed January 9, 2017.
8. American Academy of Family Physicians. AAFP to NBME: cease claims of equivalence between FPs and Advanced Practice Nurses. www.aafp.org/news/professional-issues/20100811nbmeletter.html. Accessed January 9, 2017.
9. Schierhorn C. As NPs push for expanded practice rights, physicians push back. http://thedo.osteopathic.org/2010/03/as-nps-push-for-expanded-practice-rights-physicians-push-back. Accessed January 9, 2017.
10. Doble M. Keep a positive spin on the progress of full practice authority for NPs. www.nursingcenter.com/ncblog/july-2015/keep-a-positive-spin-on-the-progress-of-full-pract. Accessed January 9, 2017.
11. The Department of Veterans Affairs. VA grants full practice authority to advance practice registered nurses. www.va.gov/opa/pressrel/pressrelease.cfm?id=2847. Accessed January 9, 2017.
12. Benesch K, Hyman DJ. Nonphysician practitioners: more care, less cost, different law? www.healthlawyers.org/Events/Programs/Materials/Documents/ArchivedProgramMaterialFolders2009-2011/PHY09/benesch_hyman.pdf. Accessed January 9, 2017.
13. Sady B. Autonomy now! Why PAs, like NPs, need full practice authority. Clinician Reviews. 2015;25(10):6-8.
14. American Academy of Physician Assistants. AAPA urged VA to grant full practice authority to PAs; VA extended authority only to APRNs. www.aapa.org/twocolumn.aspx?id= 6442451796. Accessed January 9, 2017.
15. American Academy of Physician Assistants. Full practice authority and responsibility. http://news-center.aapa.org/wp-content/uploads/sites/2/2016/12/FAQ-Final_12_15.pdf. Accessed January 9, 2017.
16. American Academy of Physician Assistants. Major PA victory in Michigan. www.aapa.org/twocolumn.aspx?id=6442451808. Accessed January 9, 2017.

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The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.1 Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.2 In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.5 Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.6

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.7 Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”8 Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.9 But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.10 Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.11

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.12 This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.13

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.14 And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.15 This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.16

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

 

The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.1 Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.2 In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.5 Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.6

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.7 Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”8 Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.9 But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.10 Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.11

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.12 This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.13

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.14 And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.15 This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.16

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

References

1. American Association of Nurse Practitioners. Issues at-a glance: full practice authority. www.aanp.org/aanpqa2/images/documents/policy-toolbox/fullpracticeauthority.pdf. Accessed January 9, 2017.
2. ECRI Institute. Scope of practice laws for nurse practitioners and physician assistants. www.ecri.org/components/PPRM/Pages/LB5.aspx. Accessed January 9, 2017.
3. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2010/The-Future-of-Nursing/Future%20of%20Nursing%202010%20Recommendations.pdf. Accessed January 9, 2017.
4. National Governors Association. The role of nurse practitioners in meeting increasing demand for primary care. www.nga.org/cms/home/nga-center-for-best-practices/center-publications/page-health-publications/col2-content/main-content-list/the-role-of-nurse-practitioners.html. Accessed January 9, 2017.
5. Martsolf GR, Auerbach DI, Arifkhanova A. The impact of full practice authority for nurse practitioners and other advanced practice registered nurses in Ohio. www.rand.org/content/dam/rand/pubs/research_reports/RR800/RR848/RAND_RR848.pdf. Accessed January 9, 2017.
6. Gilman DJ, Koslov TI. Policy perspectives: competition advocacy and the regulation of advanced practice nurses. www.aacn.nche.edu/government-affairs/APRN-Policy-Paper.pdf. Accessed January 9, 2017.
7. American Academy of Family Physicians. AAFP, others protest VA’s attempt to expand APRNs’ scope of practice. www.aafp.org/news/government-medicine/20131122valetteraprn.html. Accessed January 9, 2017.
8. American Academy of Family Physicians. AAFP to NBME: cease claims of equivalence between FPs and Advanced Practice Nurses. www.aafp.org/news/professional-issues/20100811nbmeletter.html. Accessed January 9, 2017.
9. Schierhorn C. As NPs push for expanded practice rights, physicians push back. http://thedo.osteopathic.org/2010/03/as-nps-push-for-expanded-practice-rights-physicians-push-back. Accessed January 9, 2017.
10. Doble M. Keep a positive spin on the progress of full practice authority for NPs. www.nursingcenter.com/ncblog/july-2015/keep-a-positive-spin-on-the-progress-of-full-pract. Accessed January 9, 2017.
11. The Department of Veterans Affairs. VA grants full practice authority to advance practice registered nurses. www.va.gov/opa/pressrel/pressrelease.cfm?id=2847. Accessed January 9, 2017.
12. Benesch K, Hyman DJ. Nonphysician practitioners: more care, less cost, different law? www.healthlawyers.org/Events/Programs/Materials/Documents/ArchivedProgramMaterialFolders2009-2011/PHY09/benesch_hyman.pdf. Accessed January 9, 2017.
13. Sady B. Autonomy now! Why PAs, like NPs, need full practice authority. Clinician Reviews. 2015;25(10):6-8.
14. American Academy of Physician Assistants. AAPA urged VA to grant full practice authority to PAs; VA extended authority only to APRNs. www.aapa.org/twocolumn.aspx?id= 6442451796. Accessed January 9, 2017.
15. American Academy of Physician Assistants. Full practice authority and responsibility. http://news-center.aapa.org/wp-content/uploads/sites/2/2016/12/FAQ-Final_12_15.pdf. Accessed January 9, 2017.
16. American Academy of Physician Assistants. Major PA victory in Michigan. www.aapa.org/twocolumn.aspx?id=6442451808. Accessed January 9, 2017.

References

1. American Association of Nurse Practitioners. Issues at-a glance: full practice authority. www.aanp.org/aanpqa2/images/documents/policy-toolbox/fullpracticeauthority.pdf. Accessed January 9, 2017.
2. ECRI Institute. Scope of practice laws for nurse practitioners and physician assistants. www.ecri.org/components/PPRM/Pages/LB5.aspx. Accessed January 9, 2017.
3. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2010/The-Future-of-Nursing/Future%20of%20Nursing%202010%20Recommendations.pdf. Accessed January 9, 2017.
4. National Governors Association. The role of nurse practitioners in meeting increasing demand for primary care. www.nga.org/cms/home/nga-center-for-best-practices/center-publications/page-health-publications/col2-content/main-content-list/the-role-of-nurse-practitioners.html. Accessed January 9, 2017.
5. Martsolf GR, Auerbach DI, Arifkhanova A. The impact of full practice authority for nurse practitioners and other advanced practice registered nurses in Ohio. www.rand.org/content/dam/rand/pubs/research_reports/RR800/RR848/RAND_RR848.pdf. Accessed January 9, 2017.
6. Gilman DJ, Koslov TI. Policy perspectives: competition advocacy and the regulation of advanced practice nurses. www.aacn.nche.edu/government-affairs/APRN-Policy-Paper.pdf. Accessed January 9, 2017.
7. American Academy of Family Physicians. AAFP, others protest VA’s attempt to expand APRNs’ scope of practice. www.aafp.org/news/government-medicine/20131122valetteraprn.html. Accessed January 9, 2017.
8. American Academy of Family Physicians. AAFP to NBME: cease claims of equivalence between FPs and Advanced Practice Nurses. www.aafp.org/news/professional-issues/20100811nbmeletter.html. Accessed January 9, 2017.
9. Schierhorn C. As NPs push for expanded practice rights, physicians push back. http://thedo.osteopathic.org/2010/03/as-nps-push-for-expanded-practice-rights-physicians-push-back. Accessed January 9, 2017.
10. Doble M. Keep a positive spin on the progress of full practice authority for NPs. www.nursingcenter.com/ncblog/july-2015/keep-a-positive-spin-on-the-progress-of-full-pract. Accessed January 9, 2017.
11. The Department of Veterans Affairs. VA grants full practice authority to advance practice registered nurses. www.va.gov/opa/pressrel/pressrelease.cfm?id=2847. Accessed January 9, 2017.
12. Benesch K, Hyman DJ. Nonphysician practitioners: more care, less cost, different law? www.healthlawyers.org/Events/Programs/Materials/Documents/ArchivedProgramMaterialFolders2009-2011/PHY09/benesch_hyman.pdf. Accessed January 9, 2017.
13. Sady B. Autonomy now! Why PAs, like NPs, need full practice authority. Clinician Reviews. 2015;25(10):6-8.
14. American Academy of Physician Assistants. AAPA urged VA to grant full practice authority to PAs; VA extended authority only to APRNs. www.aapa.org/twocolumn.aspx?id= 6442451796. Accessed January 9, 2017.
15. American Academy of Physician Assistants. Full practice authority and responsibility. http://news-center.aapa.org/wp-content/uploads/sites/2/2016/12/FAQ-Final_12_15.pdf. Accessed January 9, 2017.
16. American Academy of Physician Assistants. Major PA victory in Michigan. www.aapa.org/twocolumn.aspx?id=6442451808. Accessed January 9, 2017.

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The New Opioid Epidemic and the Law of Unintended Consequences

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In this issue of EM, EP-toxicologists Rama Rao, MD, and Lewis Nelson, MD, review the salient features of the current opioid epidemic in the United States. The authors differentiate this epidemic from prior patterns of heroin and opioid abuse partly by the clinical features that now make timely diagnosis and treatment in the ED more difficult.

According to the CDC, between 2000 and 2015, the number of opioid overdose deaths in this country quadrupled to half a million, or 91 deaths a day (http://bit.ly/2jEOHfs). We know now that prescription opioids have been driving this 15-year increase. Since 1999, both the amount of opioids prescribed and the number of opioid deaths in the US have quadrupled. Ironically, during that same period, the amount of pain reported has not changed overall (http://bit.ly/2jEOHfs). In 2015 alone, opioids were involved with 33,091 deaths, of which more than 15,000 were due to prescription opioid overdoses—most commonly methadone, oxycodone, and hydrocodone (http://bit.ly/2jZ1TfO and http://bit.ly/2iwagAI). Adding to the misery has been a sharp increase in deaths due to heroin since 2010, and a similar increase in deaths due to fentanyl, tramadol, and other synthetics since 2013. Currently, more than 1,000 people are treated in EDs each day for misusing prescription opioids (http://bit.ly/2iwagAI).

The road to the current epidemic began to be paved with good intentions in the late 1990s when, soon after the FDA approved the controlled-release form of oxycodone (Oxycontin), the American Pain Society introduced the phrase “pain as the fifth vital sign.” In 1999, the Department of Veterans Affairs embraced the statement, as did other organizations. The Joint Commission standards for pain management in 2001 stated “pain is assessed in all patients” (all was dropped in 2009) and contained a passing reference to pain as the fifth vital sign. In 2012, CMS added to its ED performance core measures timely pain treatment for long bone fractures, emphasizing parenteral medications.

By 2010, the problems created by emphasizing effective pain management had become evident, and measures began to be introduced to restrict the prescribing and availability of pharmaceutical opioids. The restrictions sent many patients to EDs seeking pain meds. Others sought substitutes on the street and ultimately ended up in EDs as overdoses from very potent synthetics. Many EPs began to limit opioid prescriptions to 3 days for acute painful conditions, though not all patients were able to obtain follow-up appointments with PCPs within that time period. 

In April 2016, the Joint Commission issued a statement claiming it was not responsible for “pain as the fifth vital sign” or for suggesting that pain be treated with opioids. In June 2016, the AMA urged dropping “pain-as-the-fifth-vital-sign” policies, and in 2014, CMS modified its core measure emphasis on parenteral medication in the timely treatment of long bone fractures. But the damage has been done, leaving many people requiring help managing their pain and others suffering the consequences of opioid dependence.

EPs must continue to deal with victims of overdoses without denying pain treatment to those with acute, acute-on-chronic, and recurrent pain. Increased use of effective non-opioid pain meds such as NSAIDs may help, although not everyone can tolerate them and there are long-term risks. For large, overcrowded, urban EDs where treatment of pain is not always timely or consistent, 24/7 ED pain management teams working with EPs could be a tremendous asset, just as 24/7 ED pharmacists have proven to be. Until both effective pain treatment and the resultant opioid dependence and overdoses can be successfully addressed, regulatory agencies should deemphasize, without completely eliminating, pain treatment questions in scoring patient satisfaction. 

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In this issue of EM, EP-toxicologists Rama Rao, MD, and Lewis Nelson, MD, review the salient features of the current opioid epidemic in the United States. The authors differentiate this epidemic from prior patterns of heroin and opioid abuse partly by the clinical features that now make timely diagnosis and treatment in the ED more difficult.

According to the CDC, between 2000 and 2015, the number of opioid overdose deaths in this country quadrupled to half a million, or 91 deaths a day (http://bit.ly/2jEOHfs). We know now that prescription opioids have been driving this 15-year increase. Since 1999, both the amount of opioids prescribed and the number of opioid deaths in the US have quadrupled. Ironically, during that same period, the amount of pain reported has not changed overall (http://bit.ly/2jEOHfs). In 2015 alone, opioids were involved with 33,091 deaths, of which more than 15,000 were due to prescription opioid overdoses—most commonly methadone, oxycodone, and hydrocodone (http://bit.ly/2jZ1TfO and http://bit.ly/2iwagAI). Adding to the misery has been a sharp increase in deaths due to heroin since 2010, and a similar increase in deaths due to fentanyl, tramadol, and other synthetics since 2013. Currently, more than 1,000 people are treated in EDs each day for misusing prescription opioids (http://bit.ly/2iwagAI).

The road to the current epidemic began to be paved with good intentions in the late 1990s when, soon after the FDA approved the controlled-release form of oxycodone (Oxycontin), the American Pain Society introduced the phrase “pain as the fifth vital sign.” In 1999, the Department of Veterans Affairs embraced the statement, as did other organizations. The Joint Commission standards for pain management in 2001 stated “pain is assessed in all patients” (all was dropped in 2009) and contained a passing reference to pain as the fifth vital sign. In 2012, CMS added to its ED performance core measures timely pain treatment for long bone fractures, emphasizing parenteral medications.

By 2010, the problems created by emphasizing effective pain management had become evident, and measures began to be introduced to restrict the prescribing and availability of pharmaceutical opioids. The restrictions sent many patients to EDs seeking pain meds. Others sought substitutes on the street and ultimately ended up in EDs as overdoses from very potent synthetics. Many EPs began to limit opioid prescriptions to 3 days for acute painful conditions, though not all patients were able to obtain follow-up appointments with PCPs within that time period. 

In April 2016, the Joint Commission issued a statement claiming it was not responsible for “pain as the fifth vital sign” or for suggesting that pain be treated with opioids. In June 2016, the AMA urged dropping “pain-as-the-fifth-vital-sign” policies, and in 2014, CMS modified its core measure emphasis on parenteral medication in the timely treatment of long bone fractures. But the damage has been done, leaving many people requiring help managing their pain and others suffering the consequences of opioid dependence.

EPs must continue to deal with victims of overdoses without denying pain treatment to those with acute, acute-on-chronic, and recurrent pain. Increased use of effective non-opioid pain meds such as NSAIDs may help, although not everyone can tolerate them and there are long-term risks. For large, overcrowded, urban EDs where treatment of pain is not always timely or consistent, 24/7 ED pain management teams working with EPs could be a tremendous asset, just as 24/7 ED pharmacists have proven to be. Until both effective pain treatment and the resultant opioid dependence and overdoses can be successfully addressed, regulatory agencies should deemphasize, without completely eliminating, pain treatment questions in scoring patient satisfaction. 

In this issue of EM, EP-toxicologists Rama Rao, MD, and Lewis Nelson, MD, review the salient features of the current opioid epidemic in the United States. The authors differentiate this epidemic from prior patterns of heroin and opioid abuse partly by the clinical features that now make timely diagnosis and treatment in the ED more difficult.

According to the CDC, between 2000 and 2015, the number of opioid overdose deaths in this country quadrupled to half a million, or 91 deaths a day (http://bit.ly/2jEOHfs). We know now that prescription opioids have been driving this 15-year increase. Since 1999, both the amount of opioids prescribed and the number of opioid deaths in the US have quadrupled. Ironically, during that same period, the amount of pain reported has not changed overall (http://bit.ly/2jEOHfs). In 2015 alone, opioids were involved with 33,091 deaths, of which more than 15,000 were due to prescription opioid overdoses—most commonly methadone, oxycodone, and hydrocodone (http://bit.ly/2jZ1TfO and http://bit.ly/2iwagAI). Adding to the misery has been a sharp increase in deaths due to heroin since 2010, and a similar increase in deaths due to fentanyl, tramadol, and other synthetics since 2013. Currently, more than 1,000 people are treated in EDs each day for misusing prescription opioids (http://bit.ly/2iwagAI).

The road to the current epidemic began to be paved with good intentions in the late 1990s when, soon after the FDA approved the controlled-release form of oxycodone (Oxycontin), the American Pain Society introduced the phrase “pain as the fifth vital sign.” In 1999, the Department of Veterans Affairs embraced the statement, as did other organizations. The Joint Commission standards for pain management in 2001 stated “pain is assessed in all patients” (all was dropped in 2009) and contained a passing reference to pain as the fifth vital sign. In 2012, CMS added to its ED performance core measures timely pain treatment for long bone fractures, emphasizing parenteral medications.

By 2010, the problems created by emphasizing effective pain management had become evident, and measures began to be introduced to restrict the prescribing and availability of pharmaceutical opioids. The restrictions sent many patients to EDs seeking pain meds. Others sought substitutes on the street and ultimately ended up in EDs as overdoses from very potent synthetics. Many EPs began to limit opioid prescriptions to 3 days for acute painful conditions, though not all patients were able to obtain follow-up appointments with PCPs within that time period. 

In April 2016, the Joint Commission issued a statement claiming it was not responsible for “pain as the fifth vital sign” or for suggesting that pain be treated with opioids. In June 2016, the AMA urged dropping “pain-as-the-fifth-vital-sign” policies, and in 2014, CMS modified its core measure emphasis on parenteral medication in the timely treatment of long bone fractures. But the damage has been done, leaving many people requiring help managing their pain and others suffering the consequences of opioid dependence.

EPs must continue to deal with victims of overdoses without denying pain treatment to those with acute, acute-on-chronic, and recurrent pain. Increased use of effective non-opioid pain meds such as NSAIDs may help, although not everyone can tolerate them and there are long-term risks. For large, overcrowded, urban EDs where treatment of pain is not always timely or consistent, 24/7 ED pain management teams working with EPs could be a tremendous asset, just as 24/7 ED pharmacists have proven to be. Until both effective pain treatment and the resultant opioid dependence and overdoses can be successfully addressed, regulatory agencies should deemphasize, without completely eliminating, pain treatment questions in scoring patient satisfaction. 

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Estate planning

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Thu, 03/28/2019 - 14:56

 

The latest anniversary of my birth recently passed; I am now a provider and a beneficiary in the Medicare system. Fortunately, I have learned to celebrate these annual events, and the changes they bring, rather than dread them. I now appreciate that life gets better as we get older, on all levels – except, perhaps, the physical.

But I have also learned that birthdays are a good time to pause and consider the various financial arrangements that I’ve set up over the years, and to determine whether any of them need updating.

Dr. Joseph S. Eastern


Estate plans, in particular, need regular review and revision. Nothing important has changed in your life since you drafted your will, you say? Well, chances are the laws have changed, or other factors may have rendered your plan obsolete without your even realizing it.

I am assuming, of course, that you have in fact drafted a will. If not – regardless of your age – do it as soon as possible. Stuff happens; if you die without a will (“intestate,” in lawyer lingo), your heirs will be at the mercy of attorneys, bureaucrats, state and federal laws, and greed. Quarrels will ensue; decisions will be made that are almost certainly at variance with what you would have wanted; and a substantial chunk of your estate that could have gone to loved ones, or to charity, will be lost to taxes and legal fees.

In other words, if you don’t write a will, others will write one for you – one your heirs probably won’t like. Don’t let that happen. That said, let’s consider some variables that mandate your constant vigilance:

Laws change. Trust laws, in particular, have changed a great deal in recent years, and trust strategies have changed with them. New instruments such as perpetual trusts, trust protectors, directed trusts, and total return trusts may or may not work to your advantage, but you won’t know without asking. State laws change too.

Once a year, my wife and I meet with our estate lawyer to learn about any new legislation that may have affected our plan. A few years ago, for example, I learned that my irrevocable trust was no longer irrevocable; new laws now permit certain provisions to be modified.

Laws that don’t directly regulate wills and trusts can impact your plan as well. For instance, the ever-popular Health Insurance Portability and Accountability Act (HIPAA) applies to your estate as well as your practice; under its provisions, your family cannot access your medical information or make treatment and life-support decisions without your specific permission. So if a Health Care Power of Attorney is not already part of your will, add it. And remember to modify it if your medical status, or your philosophy of life, changes.

Financial markets change. It’s not exactly a secret that asset values and interest rates are considerably different than they were even a few years ago. Real estate or securities bequests could now be significantly larger or smaller. Your accountant and estate lawyer should take a look at your assets periodically, and their apportionment in your will, to be sure all arrangements remain as you intend. And be sure to notify them whenever the composition of your assets changes, even if their value doesn’t. Say, for example, you sell a business or property, and reinvest the proceeds in something completely different; a different set of tax laws will apply, and your will must reflect that.

Fiduciaries change. Keep track of the executor of your estate and the trustee(s) of your trust(s), and be prepared to make changes if needed. If your brother-in-law is your executor, and your sister divorces him, you may want to name a new executor. A once-vigorous trustee who is now old or sick should be replaced. Trustees are often financial institutions; if a corporate trustee goes belly up, or the employee you were working with leaves or retires, you’ll need a replacement.

Personal circumstances change. Some changes – marriage, divorce, the death of an heir, or the birth of a new one – obviously require modifications to wills and trusts. But any significant alteration of your personal or financial circumstances probably merits a phone call to your financial planners. The need for changes, and your options, are not always obvious.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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The latest anniversary of my birth recently passed; I am now a provider and a beneficiary in the Medicare system. Fortunately, I have learned to celebrate these annual events, and the changes they bring, rather than dread them. I now appreciate that life gets better as we get older, on all levels – except, perhaps, the physical.

But I have also learned that birthdays are a good time to pause and consider the various financial arrangements that I’ve set up over the years, and to determine whether any of them need updating.

Dr. Joseph S. Eastern


Estate plans, in particular, need regular review and revision. Nothing important has changed in your life since you drafted your will, you say? Well, chances are the laws have changed, or other factors may have rendered your plan obsolete without your even realizing it.

I am assuming, of course, that you have in fact drafted a will. If not – regardless of your age – do it as soon as possible. Stuff happens; if you die without a will (“intestate,” in lawyer lingo), your heirs will be at the mercy of attorneys, bureaucrats, state and federal laws, and greed. Quarrels will ensue; decisions will be made that are almost certainly at variance with what you would have wanted; and a substantial chunk of your estate that could have gone to loved ones, or to charity, will be lost to taxes and legal fees.

In other words, if you don’t write a will, others will write one for you – one your heirs probably won’t like. Don’t let that happen. That said, let’s consider some variables that mandate your constant vigilance:

Laws change. Trust laws, in particular, have changed a great deal in recent years, and trust strategies have changed with them. New instruments such as perpetual trusts, trust protectors, directed trusts, and total return trusts may or may not work to your advantage, but you won’t know without asking. State laws change too.

Once a year, my wife and I meet with our estate lawyer to learn about any new legislation that may have affected our plan. A few years ago, for example, I learned that my irrevocable trust was no longer irrevocable; new laws now permit certain provisions to be modified.

Laws that don’t directly regulate wills and trusts can impact your plan as well. For instance, the ever-popular Health Insurance Portability and Accountability Act (HIPAA) applies to your estate as well as your practice; under its provisions, your family cannot access your medical information or make treatment and life-support decisions without your specific permission. So if a Health Care Power of Attorney is not already part of your will, add it. And remember to modify it if your medical status, or your philosophy of life, changes.

Financial markets change. It’s not exactly a secret that asset values and interest rates are considerably different than they were even a few years ago. Real estate or securities bequests could now be significantly larger or smaller. Your accountant and estate lawyer should take a look at your assets periodically, and their apportionment in your will, to be sure all arrangements remain as you intend. And be sure to notify them whenever the composition of your assets changes, even if their value doesn’t. Say, for example, you sell a business or property, and reinvest the proceeds in something completely different; a different set of tax laws will apply, and your will must reflect that.

Fiduciaries change. Keep track of the executor of your estate and the trustee(s) of your trust(s), and be prepared to make changes if needed. If your brother-in-law is your executor, and your sister divorces him, you may want to name a new executor. A once-vigorous trustee who is now old or sick should be replaced. Trustees are often financial institutions; if a corporate trustee goes belly up, or the employee you were working with leaves or retires, you’ll need a replacement.

Personal circumstances change. Some changes – marriage, divorce, the death of an heir, or the birth of a new one – obviously require modifications to wills and trusts. But any significant alteration of your personal or financial circumstances probably merits a phone call to your financial planners. The need for changes, and your options, are not always obvious.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

 

The latest anniversary of my birth recently passed; I am now a provider and a beneficiary in the Medicare system. Fortunately, I have learned to celebrate these annual events, and the changes they bring, rather than dread them. I now appreciate that life gets better as we get older, on all levels – except, perhaps, the physical.

But I have also learned that birthdays are a good time to pause and consider the various financial arrangements that I’ve set up over the years, and to determine whether any of them need updating.

Dr. Joseph S. Eastern


Estate plans, in particular, need regular review and revision. Nothing important has changed in your life since you drafted your will, you say? Well, chances are the laws have changed, or other factors may have rendered your plan obsolete without your even realizing it.

I am assuming, of course, that you have in fact drafted a will. If not – regardless of your age – do it as soon as possible. Stuff happens; if you die without a will (“intestate,” in lawyer lingo), your heirs will be at the mercy of attorneys, bureaucrats, state and federal laws, and greed. Quarrels will ensue; decisions will be made that are almost certainly at variance with what you would have wanted; and a substantial chunk of your estate that could have gone to loved ones, or to charity, will be lost to taxes and legal fees.

In other words, if you don’t write a will, others will write one for you – one your heirs probably won’t like. Don’t let that happen. That said, let’s consider some variables that mandate your constant vigilance:

Laws change. Trust laws, in particular, have changed a great deal in recent years, and trust strategies have changed with them. New instruments such as perpetual trusts, trust protectors, directed trusts, and total return trusts may or may not work to your advantage, but you won’t know without asking. State laws change too.

Once a year, my wife and I meet with our estate lawyer to learn about any new legislation that may have affected our plan. A few years ago, for example, I learned that my irrevocable trust was no longer irrevocable; new laws now permit certain provisions to be modified.

Laws that don’t directly regulate wills and trusts can impact your plan as well. For instance, the ever-popular Health Insurance Portability and Accountability Act (HIPAA) applies to your estate as well as your practice; under its provisions, your family cannot access your medical information or make treatment and life-support decisions without your specific permission. So if a Health Care Power of Attorney is not already part of your will, add it. And remember to modify it if your medical status, or your philosophy of life, changes.

Financial markets change. It’s not exactly a secret that asset values and interest rates are considerably different than they were even a few years ago. Real estate or securities bequests could now be significantly larger or smaller. Your accountant and estate lawyer should take a look at your assets periodically, and their apportionment in your will, to be sure all arrangements remain as you intend. And be sure to notify them whenever the composition of your assets changes, even if their value doesn’t. Say, for example, you sell a business or property, and reinvest the proceeds in something completely different; a different set of tax laws will apply, and your will must reflect that.

Fiduciaries change. Keep track of the executor of your estate and the trustee(s) of your trust(s), and be prepared to make changes if needed. If your brother-in-law is your executor, and your sister divorces him, you may want to name a new executor. A once-vigorous trustee who is now old or sick should be replaced. Trustees are often financial institutions; if a corporate trustee goes belly up, or the employee you were working with leaves or retires, you’ll need a replacement.

Personal circumstances change. Some changes – marriage, divorce, the death of an heir, or the birth of a new one – obviously require modifications to wills and trusts. But any significant alteration of your personal or financial circumstances probably merits a phone call to your financial planners. The need for changes, and your options, are not always obvious.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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The PERT Movement – Vascular surgeons must answer the call

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Mon, 02/27/2017 - 13:09

 

Pulmonary embolism (PE) is the third most common cause of cardiovascular death in the United States and remains the most common preventable cause of in-hospital death. One might think that, in 2017, such a life-threatening cardiovascular emergency would be managed by guideline-driven care based upon robust evidence gathered through clinical trials and large observational studies. Yet, unlike stroke and myocardial infarction (STEMI), a true consensus for best management of acute PE has not been reached.

Management of PE has received increasing attention recently at major cardiovascular meetings such as VEITH, TCT, and national and regional societies. This excitement has been driven by recent trial data demonstrating that right ventricular failure with an acute PE is associated with poor outcomes and rapid clot debulking can reduce mortality not only in patients with high risk (massive) PE but even in intermediate risk (submassive) PE.

Charles B. Ross, MD


Systemic thrombolysis has been the standard of care for higher risk PEs but multiple contraindications and high complication rates shifted care toward catheter interventions assumed to have a safer profile. The huge gap of past decades between therapeutic anticoagulation alone versus systemic thrombolysis or surgical pulmonary embolectomy has been filled with an array of catheter-based techniques. Contemporary management of intermediate and high-risk PE employs thrombolytic infusion catheters at the clot site with or without ultrasound technology, mechanical fragmentation, and aspiration/suction thrombectomy devices. These techniques may lack robust evidence supporting them, still their use has been exponentially growing over the past 2 years. Yet, there is no clear consensus guiding management. Who needs to be treated? What’s the best technique for any given patient? What are the therapeutic endpoints? A myriad of questions remain to be answered.

Uncertainty about best management for an individual patient with acute PE stimulated formation of a multidisciplinary, collaborative approach beginning in 2012 at Massachusetts General Hospital in Boston.
Efthymios D. Avgerinos, MD


This approach, led by Kenneth Rosenfield, MD, involved the formal development of a call team of various specialists who would be rapidly activated to develop a care plan for any patient with acute PE. The term “Pulmonary Embolism Response Team” (PERT) was coined by MGH pulmonologist Richard Channick, MD, and since then, the PERT approach has been adopted by more than 100 centers across the United States and internationally.

Rapid communication between frontline physicians who diagnose PE and those who can offer definitive management is the hallmark of the PERT approach. PERTs at both Piedmont Atlanta Hospital (care plan shown below) and the University of Pittsburgh Medical Center (UPMC) function similarly. Patients are triaged by a critical care pulmonologist. For those with massive PE (hemodynamically unstable), the emergency call center establishes a cellular link between the bedside emergency physician, triaging critical care pulmonologist, the PE interventionalist, cardiothoracic surgeon, and ECMO team. CTAs may be viewed electronically, management plans initiated, and teams rapidly mobilized. For patients with submassive PE, the triaging critical care pulmonologist initiates management discussion with the “PE interventionalist” on call. Patient presentation, physiologic data, biomarkers, and preexisting comorbidities are discussed. CTAs are viewed. Multiple treatment plans are considered from traditional medical management to catheter-based techniques for more peripheral emboli to surgical pulmonary embolectomy for centrally located thrombus. Treatment plans are influenced by factors such as patient age and comorbidity and are collaboratively tailored to each individual patient.

Management decisions for acute PE are driven by risk stratification. Most patients who present with PE are considered “low risk” for PE-related death and are managed with therapeutic anticoagulation. Five percent of patients present with massive PE characterized by shock and are at “high-risk” for PE-related death. These patients require intervention. Up to 40% of patients present with submassive PE. These patients are hemodynamically stable (not hypotensive) but have evidence on CTA or echocardiogram for right ventricular dysfunction and are at “intermediate risk” for PE-related death. This group is further stratified as intermediate low-risk vs. intermediate high-risk by biomarkers that indicate myocardial damage, primarily troponin and BNP. In this intermediate-risk or submassive group, intervention is more commonly offered to those patients stratified as intermediate “high-risk.”

Significant variability in the management of both massive and submassive PE patients beyond therapeutic anticoagulation, e.g., upon whom to offer intervention and how, is the point where a PERT may have greatest impact. Rapid, collaborative decision making between physicians/surgeons from multiple specialties offers hope for minimizing morbidity and achievement of best outcome.

Who is the “Pulmonary Interventionalist” and where does the contemporarily-trained vascular surgeon with catheter and critical-care skills fit into this new paradigm? The answer to this question depends on each individual institution.

At the University of Pittsburgh Medical Center and Piedmont Heart and Vascular Institute at Piedmont Atlanta Hospital, catheter-based intervention programs for PE were initiated by vascular surgeons. As their interest developed over time, interventional cardiologists joined th “PE Interventional” call as full participants in the PERT programs.

PE interventions at other institutions such as Emory Midtown Medical Center in Atlanta have been driven by interventional cardiology in partnership with cardiothoracic surgery. Still, at others, such as Miami Heart and Vascular Institute, vascular and interventional radiology has led the charge. PE intervention, not owned by any single specialty, has been taken on by those groups interested in answering the call. In the case of the two programs that we represent, it was our established involvement in major venous interventions that followed a natural progression to PE intervention.

Management of PE may be challenging. Multidisciplinary collaboration is key. Recognition of the importance of collaboration in moving the field forward (and saving lives) led Dr. Rosenfield and others to host the first PERT Consortium Meeting in Boston 2015. This clarion call was answered by 80 individuals representing 40 institutions.

In 2016, the PERT Consortium was incorporated, and in June 2016, more than 140 people from nearly 80 institutions attended the second annual meeting. We attended the meeting last June, and with concern we noted only a few vascular surgeons representing other institutions. A participant survey, later published in a letter in CHEST (December 2016), suggested little involvement of vascular surgeons in PERT programs. Was this an artifact based on a survey of “those registered in the PERT mailing list” or does this represent the true interest of vascular surgeons in managing PE in this country? Whether the meeting survey accurately reflects the current involvement of vascular surgeons in the care of PE or not, one thing is certain: Vascular surgical visibility, as a specialty, in PE is poor.

Failure to be involved in the PERT movement deprives patients of the experience of vascular surgeons and potentially threatens the venous intervention practice of nonparticipating surgeons. Forty percent or more of cases of iliofemoral venous thrombosis have associated PE. Vena cava thrombosis may present with PE. Inferior vena cava tumors such as leiomyomatosis may be mistaken for PE. It is foreseeable that PERT activation will represent the gateway to care for many of these patients, who may in turn receive their care from others new to the management of venous and VTE disease.

Participation in a collaborative decision among colleagues about the best way to treat an individual patient is a gratifying experience. When the treatment fits, relieving the struggle of a patient with an acute PE through catheter-directed thrombus dissolution and debulking represents an opportunity to save productive lives using techniques that lie within the skill set of the contemporarily trained vascular surgeon. A save in the case of a challenging PE can be every bit as rewarding as successful management of a ruptured aneurysm.

Even in metropolitan regions, patients with acute PE are underserved because specialized care is frequently unavailable or PE programs nonexistent. In communities and hospitals where vascular surgeons represent the lead interventionalists, involvement in this field might even be considered a solemn responsibility.

Vascular surgeons such as Peter Lin, MD, previously at the University of Texas in Houston, and the group led by Rabih Chaer, MD, at UPMC, have advanced the science of PE intervention over the past 7 years. It is time for more vascular surgeons to enter the field and embrace pulmonary interventions. To achieve this, we need to embrace collaboration with pulmonary and critical care as well as emergency medicine since these are the main referral specialties. We need to promote initiatives participating in our local PERTs or bringing specialists together to start one where nonexistent. There is no reason for exclusivity, and collaboration with other interventionalists is essential for smooth interspecialty relations, multidisciplinary approaches, and optimal outcomes.

Academic and large community vascular centers need to include the vascular surgeons’ role in their descriptions of their PERTs. Toward this direction the vascular division of UPMC is consistently presenting and publishing results and outcomes of PE catheter interventions; very recently a randomized trial (SUNSET sPE) comparing lysis outcomes with and without ultrasound acceleration has been launched by the UPMC PERT, led and coordinated by vascular surgeons, and has already stimulated national interest. Vascular surgeons at Piedmont Heart and Vascular Institute are participating in national clinical trials (OPTALYSE) and actively collaborating with other PERT programs to advance the management of acute PE in Georgia and the southeast. Both UPMC and Piedmont Heart and Vascular Institute are founding institutional members of the PERT Consortium.

The third annual meeting of the PERT Consortium will occur in Boston in June 2017. Vascular surgeons who attend will assuredly be welcome. Answer the call.


 

 

 

Charles B. Ross, MD, is chief, Vascular and Endovascular Services, Piedmont Heart Institute, Atlanta. Efthymios Avgerinos, MD, is associate professor of surgery, Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center. They had no relevant disclosures.

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Pulmonary embolism (PE) is the third most common cause of cardiovascular death in the United States and remains the most common preventable cause of in-hospital death. One might think that, in 2017, such a life-threatening cardiovascular emergency would be managed by guideline-driven care based upon robust evidence gathered through clinical trials and large observational studies. Yet, unlike stroke and myocardial infarction (STEMI), a true consensus for best management of acute PE has not been reached.

Management of PE has received increasing attention recently at major cardiovascular meetings such as VEITH, TCT, and national and regional societies. This excitement has been driven by recent trial data demonstrating that right ventricular failure with an acute PE is associated with poor outcomes and rapid clot debulking can reduce mortality not only in patients with high risk (massive) PE but even in intermediate risk (submassive) PE.

Charles B. Ross, MD


Systemic thrombolysis has been the standard of care for higher risk PEs but multiple contraindications and high complication rates shifted care toward catheter interventions assumed to have a safer profile. The huge gap of past decades between therapeutic anticoagulation alone versus systemic thrombolysis or surgical pulmonary embolectomy has been filled with an array of catheter-based techniques. Contemporary management of intermediate and high-risk PE employs thrombolytic infusion catheters at the clot site with or without ultrasound technology, mechanical fragmentation, and aspiration/suction thrombectomy devices. These techniques may lack robust evidence supporting them, still their use has been exponentially growing over the past 2 years. Yet, there is no clear consensus guiding management. Who needs to be treated? What’s the best technique for any given patient? What are the therapeutic endpoints? A myriad of questions remain to be answered.

Uncertainty about best management for an individual patient with acute PE stimulated formation of a multidisciplinary, collaborative approach beginning in 2012 at Massachusetts General Hospital in Boston.
Efthymios D. Avgerinos, MD


This approach, led by Kenneth Rosenfield, MD, involved the formal development of a call team of various specialists who would be rapidly activated to develop a care plan for any patient with acute PE. The term “Pulmonary Embolism Response Team” (PERT) was coined by MGH pulmonologist Richard Channick, MD, and since then, the PERT approach has been adopted by more than 100 centers across the United States and internationally.

Rapid communication between frontline physicians who diagnose PE and those who can offer definitive management is the hallmark of the PERT approach. PERTs at both Piedmont Atlanta Hospital (care plan shown below) and the University of Pittsburgh Medical Center (UPMC) function similarly. Patients are triaged by a critical care pulmonologist. For those with massive PE (hemodynamically unstable), the emergency call center establishes a cellular link between the bedside emergency physician, triaging critical care pulmonologist, the PE interventionalist, cardiothoracic surgeon, and ECMO team. CTAs may be viewed electronically, management plans initiated, and teams rapidly mobilized. For patients with submassive PE, the triaging critical care pulmonologist initiates management discussion with the “PE interventionalist” on call. Patient presentation, physiologic data, biomarkers, and preexisting comorbidities are discussed. CTAs are viewed. Multiple treatment plans are considered from traditional medical management to catheter-based techniques for more peripheral emboli to surgical pulmonary embolectomy for centrally located thrombus. Treatment plans are influenced by factors such as patient age and comorbidity and are collaboratively tailored to each individual patient.

Management decisions for acute PE are driven by risk stratification. Most patients who present with PE are considered “low risk” for PE-related death and are managed with therapeutic anticoagulation. Five percent of patients present with massive PE characterized by shock and are at “high-risk” for PE-related death. These patients require intervention. Up to 40% of patients present with submassive PE. These patients are hemodynamically stable (not hypotensive) but have evidence on CTA or echocardiogram for right ventricular dysfunction and are at “intermediate risk” for PE-related death. This group is further stratified as intermediate low-risk vs. intermediate high-risk by biomarkers that indicate myocardial damage, primarily troponin and BNP. In this intermediate-risk or submassive group, intervention is more commonly offered to those patients stratified as intermediate “high-risk.”

Significant variability in the management of both massive and submassive PE patients beyond therapeutic anticoagulation, e.g., upon whom to offer intervention and how, is the point where a PERT may have greatest impact. Rapid, collaborative decision making between physicians/surgeons from multiple specialties offers hope for minimizing morbidity and achievement of best outcome.

Who is the “Pulmonary Interventionalist” and where does the contemporarily-trained vascular surgeon with catheter and critical-care skills fit into this new paradigm? The answer to this question depends on each individual institution.

At the University of Pittsburgh Medical Center and Piedmont Heart and Vascular Institute at Piedmont Atlanta Hospital, catheter-based intervention programs for PE were initiated by vascular surgeons. As their interest developed over time, interventional cardiologists joined th “PE Interventional” call as full participants in the PERT programs.

PE interventions at other institutions such as Emory Midtown Medical Center in Atlanta have been driven by interventional cardiology in partnership with cardiothoracic surgery. Still, at others, such as Miami Heart and Vascular Institute, vascular and interventional radiology has led the charge. PE intervention, not owned by any single specialty, has been taken on by those groups interested in answering the call. In the case of the two programs that we represent, it was our established involvement in major venous interventions that followed a natural progression to PE intervention.

Management of PE may be challenging. Multidisciplinary collaboration is key. Recognition of the importance of collaboration in moving the field forward (and saving lives) led Dr. Rosenfield and others to host the first PERT Consortium Meeting in Boston 2015. This clarion call was answered by 80 individuals representing 40 institutions.

In 2016, the PERT Consortium was incorporated, and in June 2016, more than 140 people from nearly 80 institutions attended the second annual meeting. We attended the meeting last June, and with concern we noted only a few vascular surgeons representing other institutions. A participant survey, later published in a letter in CHEST (December 2016), suggested little involvement of vascular surgeons in PERT programs. Was this an artifact based on a survey of “those registered in the PERT mailing list” or does this represent the true interest of vascular surgeons in managing PE in this country? Whether the meeting survey accurately reflects the current involvement of vascular surgeons in the care of PE or not, one thing is certain: Vascular surgical visibility, as a specialty, in PE is poor.

Failure to be involved in the PERT movement deprives patients of the experience of vascular surgeons and potentially threatens the venous intervention practice of nonparticipating surgeons. Forty percent or more of cases of iliofemoral venous thrombosis have associated PE. Vena cava thrombosis may present with PE. Inferior vena cava tumors such as leiomyomatosis may be mistaken for PE. It is foreseeable that PERT activation will represent the gateway to care for many of these patients, who may in turn receive their care from others new to the management of venous and VTE disease.

Participation in a collaborative decision among colleagues about the best way to treat an individual patient is a gratifying experience. When the treatment fits, relieving the struggle of a patient with an acute PE through catheter-directed thrombus dissolution and debulking represents an opportunity to save productive lives using techniques that lie within the skill set of the contemporarily trained vascular surgeon. A save in the case of a challenging PE can be every bit as rewarding as successful management of a ruptured aneurysm.

Even in metropolitan regions, patients with acute PE are underserved because specialized care is frequently unavailable or PE programs nonexistent. In communities and hospitals where vascular surgeons represent the lead interventionalists, involvement in this field might even be considered a solemn responsibility.

Vascular surgeons such as Peter Lin, MD, previously at the University of Texas in Houston, and the group led by Rabih Chaer, MD, at UPMC, have advanced the science of PE intervention over the past 7 years. It is time for more vascular surgeons to enter the field and embrace pulmonary interventions. To achieve this, we need to embrace collaboration with pulmonary and critical care as well as emergency medicine since these are the main referral specialties. We need to promote initiatives participating in our local PERTs or bringing specialists together to start one where nonexistent. There is no reason for exclusivity, and collaboration with other interventionalists is essential for smooth interspecialty relations, multidisciplinary approaches, and optimal outcomes.

Academic and large community vascular centers need to include the vascular surgeons’ role in their descriptions of their PERTs. Toward this direction the vascular division of UPMC is consistently presenting and publishing results and outcomes of PE catheter interventions; very recently a randomized trial (SUNSET sPE) comparing lysis outcomes with and without ultrasound acceleration has been launched by the UPMC PERT, led and coordinated by vascular surgeons, and has already stimulated national interest. Vascular surgeons at Piedmont Heart and Vascular Institute are participating in national clinical trials (OPTALYSE) and actively collaborating with other PERT programs to advance the management of acute PE in Georgia and the southeast. Both UPMC and Piedmont Heart and Vascular Institute are founding institutional members of the PERT Consortium.

The third annual meeting of the PERT Consortium will occur in Boston in June 2017. Vascular surgeons who attend will assuredly be welcome. Answer the call.


 

 

 

Charles B. Ross, MD, is chief, Vascular and Endovascular Services, Piedmont Heart Institute, Atlanta. Efthymios Avgerinos, MD, is associate professor of surgery, Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center. They had no relevant disclosures.

 

Pulmonary embolism (PE) is the third most common cause of cardiovascular death in the United States and remains the most common preventable cause of in-hospital death. One might think that, in 2017, such a life-threatening cardiovascular emergency would be managed by guideline-driven care based upon robust evidence gathered through clinical trials and large observational studies. Yet, unlike stroke and myocardial infarction (STEMI), a true consensus for best management of acute PE has not been reached.

Management of PE has received increasing attention recently at major cardiovascular meetings such as VEITH, TCT, and national and regional societies. This excitement has been driven by recent trial data demonstrating that right ventricular failure with an acute PE is associated with poor outcomes and rapid clot debulking can reduce mortality not only in patients with high risk (massive) PE but even in intermediate risk (submassive) PE.

Charles B. Ross, MD


Systemic thrombolysis has been the standard of care for higher risk PEs but multiple contraindications and high complication rates shifted care toward catheter interventions assumed to have a safer profile. The huge gap of past decades between therapeutic anticoagulation alone versus systemic thrombolysis or surgical pulmonary embolectomy has been filled with an array of catheter-based techniques. Contemporary management of intermediate and high-risk PE employs thrombolytic infusion catheters at the clot site with or without ultrasound technology, mechanical fragmentation, and aspiration/suction thrombectomy devices. These techniques may lack robust evidence supporting them, still their use has been exponentially growing over the past 2 years. Yet, there is no clear consensus guiding management. Who needs to be treated? What’s the best technique for any given patient? What are the therapeutic endpoints? A myriad of questions remain to be answered.

Uncertainty about best management for an individual patient with acute PE stimulated formation of a multidisciplinary, collaborative approach beginning in 2012 at Massachusetts General Hospital in Boston.
Efthymios D. Avgerinos, MD


This approach, led by Kenneth Rosenfield, MD, involved the formal development of a call team of various specialists who would be rapidly activated to develop a care plan for any patient with acute PE. The term “Pulmonary Embolism Response Team” (PERT) was coined by MGH pulmonologist Richard Channick, MD, and since then, the PERT approach has been adopted by more than 100 centers across the United States and internationally.

Rapid communication between frontline physicians who diagnose PE and those who can offer definitive management is the hallmark of the PERT approach. PERTs at both Piedmont Atlanta Hospital (care plan shown below) and the University of Pittsburgh Medical Center (UPMC) function similarly. Patients are triaged by a critical care pulmonologist. For those with massive PE (hemodynamically unstable), the emergency call center establishes a cellular link between the bedside emergency physician, triaging critical care pulmonologist, the PE interventionalist, cardiothoracic surgeon, and ECMO team. CTAs may be viewed electronically, management plans initiated, and teams rapidly mobilized. For patients with submassive PE, the triaging critical care pulmonologist initiates management discussion with the “PE interventionalist” on call. Patient presentation, physiologic data, biomarkers, and preexisting comorbidities are discussed. CTAs are viewed. Multiple treatment plans are considered from traditional medical management to catheter-based techniques for more peripheral emboli to surgical pulmonary embolectomy for centrally located thrombus. Treatment plans are influenced by factors such as patient age and comorbidity and are collaboratively tailored to each individual patient.

Management decisions for acute PE are driven by risk stratification. Most patients who present with PE are considered “low risk” for PE-related death and are managed with therapeutic anticoagulation. Five percent of patients present with massive PE characterized by shock and are at “high-risk” for PE-related death. These patients require intervention. Up to 40% of patients present with submassive PE. These patients are hemodynamically stable (not hypotensive) but have evidence on CTA or echocardiogram for right ventricular dysfunction and are at “intermediate risk” for PE-related death. This group is further stratified as intermediate low-risk vs. intermediate high-risk by biomarkers that indicate myocardial damage, primarily troponin and BNP. In this intermediate-risk or submassive group, intervention is more commonly offered to those patients stratified as intermediate “high-risk.”

Significant variability in the management of both massive and submassive PE patients beyond therapeutic anticoagulation, e.g., upon whom to offer intervention and how, is the point where a PERT may have greatest impact. Rapid, collaborative decision making between physicians/surgeons from multiple specialties offers hope for minimizing morbidity and achievement of best outcome.

Who is the “Pulmonary Interventionalist” and where does the contemporarily-trained vascular surgeon with catheter and critical-care skills fit into this new paradigm? The answer to this question depends on each individual institution.

At the University of Pittsburgh Medical Center and Piedmont Heart and Vascular Institute at Piedmont Atlanta Hospital, catheter-based intervention programs for PE were initiated by vascular surgeons. As their interest developed over time, interventional cardiologists joined th “PE Interventional” call as full participants in the PERT programs.

PE interventions at other institutions such as Emory Midtown Medical Center in Atlanta have been driven by interventional cardiology in partnership with cardiothoracic surgery. Still, at others, such as Miami Heart and Vascular Institute, vascular and interventional radiology has led the charge. PE intervention, not owned by any single specialty, has been taken on by those groups interested in answering the call. In the case of the two programs that we represent, it was our established involvement in major venous interventions that followed a natural progression to PE intervention.

Management of PE may be challenging. Multidisciplinary collaboration is key. Recognition of the importance of collaboration in moving the field forward (and saving lives) led Dr. Rosenfield and others to host the first PERT Consortium Meeting in Boston 2015. This clarion call was answered by 80 individuals representing 40 institutions.

In 2016, the PERT Consortium was incorporated, and in June 2016, more than 140 people from nearly 80 institutions attended the second annual meeting. We attended the meeting last June, and with concern we noted only a few vascular surgeons representing other institutions. A participant survey, later published in a letter in CHEST (December 2016), suggested little involvement of vascular surgeons in PERT programs. Was this an artifact based on a survey of “those registered in the PERT mailing list” or does this represent the true interest of vascular surgeons in managing PE in this country? Whether the meeting survey accurately reflects the current involvement of vascular surgeons in the care of PE or not, one thing is certain: Vascular surgical visibility, as a specialty, in PE is poor.

Failure to be involved in the PERT movement deprives patients of the experience of vascular surgeons and potentially threatens the venous intervention practice of nonparticipating surgeons. Forty percent or more of cases of iliofemoral venous thrombosis have associated PE. Vena cava thrombosis may present with PE. Inferior vena cava tumors such as leiomyomatosis may be mistaken for PE. It is foreseeable that PERT activation will represent the gateway to care for many of these patients, who may in turn receive their care from others new to the management of venous and VTE disease.

Participation in a collaborative decision among colleagues about the best way to treat an individual patient is a gratifying experience. When the treatment fits, relieving the struggle of a patient with an acute PE through catheter-directed thrombus dissolution and debulking represents an opportunity to save productive lives using techniques that lie within the skill set of the contemporarily trained vascular surgeon. A save in the case of a challenging PE can be every bit as rewarding as successful management of a ruptured aneurysm.

Even in metropolitan regions, patients with acute PE are underserved because specialized care is frequently unavailable or PE programs nonexistent. In communities and hospitals where vascular surgeons represent the lead interventionalists, involvement in this field might even be considered a solemn responsibility.

Vascular surgeons such as Peter Lin, MD, previously at the University of Texas in Houston, and the group led by Rabih Chaer, MD, at UPMC, have advanced the science of PE intervention over the past 7 years. It is time for more vascular surgeons to enter the field and embrace pulmonary interventions. To achieve this, we need to embrace collaboration with pulmonary and critical care as well as emergency medicine since these are the main referral specialties. We need to promote initiatives participating in our local PERTs or bringing specialists together to start one where nonexistent. There is no reason for exclusivity, and collaboration with other interventionalists is essential for smooth interspecialty relations, multidisciplinary approaches, and optimal outcomes.

Academic and large community vascular centers need to include the vascular surgeons’ role in their descriptions of their PERTs. Toward this direction the vascular division of UPMC is consistently presenting and publishing results and outcomes of PE catheter interventions; very recently a randomized trial (SUNSET sPE) comparing lysis outcomes with and without ultrasound acceleration has been launched by the UPMC PERT, led and coordinated by vascular surgeons, and has already stimulated national interest. Vascular surgeons at Piedmont Heart and Vascular Institute are participating in national clinical trials (OPTALYSE) and actively collaborating with other PERT programs to advance the management of acute PE in Georgia and the southeast. Both UPMC and Piedmont Heart and Vascular Institute are founding institutional members of the PERT Consortium.

The third annual meeting of the PERT Consortium will occur in Boston in June 2017. Vascular surgeons who attend will assuredly be welcome. Answer the call.


 

 

 

Charles B. Ross, MD, is chief, Vascular and Endovascular Services, Piedmont Heart Institute, Atlanta. Efthymios Avgerinos, MD, is associate professor of surgery, Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center. They had no relevant disclosures.

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The Pill: A pediatric perspective

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Fri, 01/18/2019 - 16:30

 

Arguably, the introduction of the birth control pill has transformed female health more than any other drug in modern medicine. Although many of us practicing now do not know life without it, its history is not that long.

“The Pill” – as it is often referred to – was introduced in May of 1950.1 At that time, prevention of pregnancy was not listed as an indication, and promoting birth control was politically, socially, and legally unacceptable. In fact, the Comstock Law prohibited public discussion and research about contraception.1 Therefore, when the birth control pill was introduced, it was for cycle control and for married women only. It was not indicated for use as contraception in the United States until 1960.

Since that time, the birth control pill has evolved dramatically, not only in its formulation but in its indications as well. As pediatricians, we do not always find it easy to discuss with parents hormonal regulation and starting a patient on the birth control pill, particularly when it will not be used for contraception. There are many fears about using hormonal control, but there are many useful indications that improve the health and well-being of the pediatric patient.

Menorrhagia and dysmenorrhea are likely the most common reasons that hormonal therapy is started in adolescence. Beginning with the lowest estrogen dose to reduce side effects is prudent, adjusting accordingly if side effects should occur. Breakthrough bleeding is a common side effect that usually improves over time. Patients should continue treatment for at least 3 months before deciding if treatment is effective or not. If breakthrough bleeding continues, increasing the estrogen component or changing to a triphasic pill might reduce bleeding.

Dr. Francine Pearce
Primary or secondary amenorrhea – no menarche by the age of 15 years or the cessation of menses for greater than 3 months – is common in adolescence for a variety of reasons. Excessive sports, poor diet, and stress tend to contribute to the onset of primary or secondary amenorrhea; polycystic ovary syndrome is another possible cause. Serum studies including HCG, FSH, prolactin, and TSH help rule out other causes that may need to be addressed. Administering norethindrone acetate 5-10 mg for 5-10 days will usually lead to bleeding.

For a child with mental or significant physical disabilities, suppression of ovulation to prevent a menstrual cycle is very useful. Extended regimens can help to completely suppress ovulation, thereby avoiding withdrawal bleeding. There is anxiety about extended regimens, but there is no greater risk with using hormonal therapy continuously vs. intermittently.2 In fact, using it continuously reduces many of the unwanted side effects associated with the use of oral contraceptive pills (OCPs), for example, heavy bleeding, headaches, and nausea. Complete suppression is difficult, but the odds are better with continuous treatment. Using monophasic OCPs for 42-63 days on and 4-7 days off can be tried. The benefit of using monophasic pills is if a dose is missed, it is easy to make it up by just taking an extra pill. Companies have come out with extended-regimen packs, for example, Seasonale, Seasonique, Quartette, and Lybrel. There now is a chewable pill known as Femcon Fe, which would be useful in those patients who are not able to swallow pills.

©areeya_ann/Thinkstock.com
Progestin-only regimens can be given as a pill (norethindrone acetate) or by injection (Depo-Provera [medroxyprogesterone]). Some important considerations for the disabled patient is that these are associated with more weight gain, which could be problematic for the patient who requires assistance. Another consideration is that progestin-only pills must be taken at the same time every day, and can be associated with increased acne. Breakthrough bleeding is also more common with progestin-only regimens, but adjusting the Depo-Provera regimen to a 10-week schedule reduces the breakthrough bleeding after 4-6 months.3

Another indication for OCPs in the adolescent patient is acne. Although the exact mechanism is not completely understood, estrogen does decrease sebum by reducing the size of the gland4, and, therefore, all OCPs can reduce acne. Norgestimate combinations have the highest androgen to progesterone binding ratio, so they are more effective than OCPs that do not. A newer progestin, drospirenone, is a 17 alpha-spironolactone derivative that produces antiandrogenic activity.5 When used in a combination OCP, acne control appears to be even greater. Hormonal therapy should be considered whenever there has been limited improvement with topical treatment or if acne breakouts are associated with the onset of menses.

Another consideration is to add spironolactone 100 mg by mouth daily to the regimen. Studies have shown it can be safely used in women to reduce acne.6 Patients should be monitored frequently for hyperkalemia, and it should not be used in patients who are already pregnant.4 Lab work should be done to rule out other causes of hyperandrogenism; lab tests would include serum testosterone, androstenedione, dehydroepiandrosterone, sex hormone–binding globulin, and prolactin.4

Premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) – which is the onset of depression, irritability, or anxiety in the second half of the menstrual cycle and remits with the onset of the menstrual cycle – also can be treated with hormonal therapy. This can be particularly helpful in teens with depression, as well as in those who are on treatment without significant resolution. PMS/PMDD appears to be best regulated with OCPs containing drospirenone,7 and using either a shortened course of the placebo phase or a continuous regimen appears to be the most beneficial.

Regardless of the indication for hormonal therapy, the initiation and management are essentially the same. Initiation can be on the first day of the menstrual cycle, on the Sunday after, or at the time of the visit. Initiation midcycle may result in breakthrough bleeding, but that will likely resolve over the next 3 months. No lab tests are required to start hormonal therapy, except for an HCG to rule out pregnancy. Weight and blood pressure should be documented so they can be monitored on follow-up visits. A detailed verbal explanation along with a handout should be provided on proper administration and side effects. Contraindications for the use of OCPs can be found on the Centers for Disease Control and Prevention’s website under medical criteria for the use of contraceptives.

Educating families and patients on their options for hormonal therapy can be life changing. Detailed questions about the menstrual cycle should be asked at every visit, and understanding the wide variety of indications for hormonal therapy can maximize treatment for a better outcome.

 

 

References

1. Can Fam Physician. 2012 Dec;58(12):e757–60.

2. J Midwifery Womens Health. 2012 Nov-Dec;57(6):585-92.

3. Obstet Gynecol. 2009;114:1428-31.

4. Semin Cutan Med Surg. 2008 Sep;27(3):188-96.

5. Pediatr Rev. 2008;29(11);386-97.

6. J Eur Acad Dermatol Venereol. 2005 Mar;19(2):163-6.

7. Obstet Gynecol. 2005 Sep;106(3):492-501.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures.

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Arguably, the introduction of the birth control pill has transformed female health more than any other drug in modern medicine. Although many of us practicing now do not know life without it, its history is not that long.

“The Pill” – as it is often referred to – was introduced in May of 1950.1 At that time, prevention of pregnancy was not listed as an indication, and promoting birth control was politically, socially, and legally unacceptable. In fact, the Comstock Law prohibited public discussion and research about contraception.1 Therefore, when the birth control pill was introduced, it was for cycle control and for married women only. It was not indicated for use as contraception in the United States until 1960.

Since that time, the birth control pill has evolved dramatically, not only in its formulation but in its indications as well. As pediatricians, we do not always find it easy to discuss with parents hormonal regulation and starting a patient on the birth control pill, particularly when it will not be used for contraception. There are many fears about using hormonal control, but there are many useful indications that improve the health and well-being of the pediatric patient.

Menorrhagia and dysmenorrhea are likely the most common reasons that hormonal therapy is started in adolescence. Beginning with the lowest estrogen dose to reduce side effects is prudent, adjusting accordingly if side effects should occur. Breakthrough bleeding is a common side effect that usually improves over time. Patients should continue treatment for at least 3 months before deciding if treatment is effective or not. If breakthrough bleeding continues, increasing the estrogen component or changing to a triphasic pill might reduce bleeding.

Dr. Francine Pearce
Primary or secondary amenorrhea – no menarche by the age of 15 years or the cessation of menses for greater than 3 months – is common in adolescence for a variety of reasons. Excessive sports, poor diet, and stress tend to contribute to the onset of primary or secondary amenorrhea; polycystic ovary syndrome is another possible cause. Serum studies including HCG, FSH, prolactin, and TSH help rule out other causes that may need to be addressed. Administering norethindrone acetate 5-10 mg for 5-10 days will usually lead to bleeding.

For a child with mental or significant physical disabilities, suppression of ovulation to prevent a menstrual cycle is very useful. Extended regimens can help to completely suppress ovulation, thereby avoiding withdrawal bleeding. There is anxiety about extended regimens, but there is no greater risk with using hormonal therapy continuously vs. intermittently.2 In fact, using it continuously reduces many of the unwanted side effects associated with the use of oral contraceptive pills (OCPs), for example, heavy bleeding, headaches, and nausea. Complete suppression is difficult, but the odds are better with continuous treatment. Using monophasic OCPs for 42-63 days on and 4-7 days off can be tried. The benefit of using monophasic pills is if a dose is missed, it is easy to make it up by just taking an extra pill. Companies have come out with extended-regimen packs, for example, Seasonale, Seasonique, Quartette, and Lybrel. There now is a chewable pill known as Femcon Fe, which would be useful in those patients who are not able to swallow pills.

©areeya_ann/Thinkstock.com
Progestin-only regimens can be given as a pill (norethindrone acetate) or by injection (Depo-Provera [medroxyprogesterone]). Some important considerations for the disabled patient is that these are associated with more weight gain, which could be problematic for the patient who requires assistance. Another consideration is that progestin-only pills must be taken at the same time every day, and can be associated with increased acne. Breakthrough bleeding is also more common with progestin-only regimens, but adjusting the Depo-Provera regimen to a 10-week schedule reduces the breakthrough bleeding after 4-6 months.3

Another indication for OCPs in the adolescent patient is acne. Although the exact mechanism is not completely understood, estrogen does decrease sebum by reducing the size of the gland4, and, therefore, all OCPs can reduce acne. Norgestimate combinations have the highest androgen to progesterone binding ratio, so they are more effective than OCPs that do not. A newer progestin, drospirenone, is a 17 alpha-spironolactone derivative that produces antiandrogenic activity.5 When used in a combination OCP, acne control appears to be even greater. Hormonal therapy should be considered whenever there has been limited improvement with topical treatment or if acne breakouts are associated with the onset of menses.

Another consideration is to add spironolactone 100 mg by mouth daily to the regimen. Studies have shown it can be safely used in women to reduce acne.6 Patients should be monitored frequently for hyperkalemia, and it should not be used in patients who are already pregnant.4 Lab work should be done to rule out other causes of hyperandrogenism; lab tests would include serum testosterone, androstenedione, dehydroepiandrosterone, sex hormone–binding globulin, and prolactin.4

Premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) – which is the onset of depression, irritability, or anxiety in the second half of the menstrual cycle and remits with the onset of the menstrual cycle – also can be treated with hormonal therapy. This can be particularly helpful in teens with depression, as well as in those who are on treatment without significant resolution. PMS/PMDD appears to be best regulated with OCPs containing drospirenone,7 and using either a shortened course of the placebo phase or a continuous regimen appears to be the most beneficial.

Regardless of the indication for hormonal therapy, the initiation and management are essentially the same. Initiation can be on the first day of the menstrual cycle, on the Sunday after, or at the time of the visit. Initiation midcycle may result in breakthrough bleeding, but that will likely resolve over the next 3 months. No lab tests are required to start hormonal therapy, except for an HCG to rule out pregnancy. Weight and blood pressure should be documented so they can be monitored on follow-up visits. A detailed verbal explanation along with a handout should be provided on proper administration and side effects. Contraindications for the use of OCPs can be found on the Centers for Disease Control and Prevention’s website under medical criteria for the use of contraceptives.

Educating families and patients on their options for hormonal therapy can be life changing. Detailed questions about the menstrual cycle should be asked at every visit, and understanding the wide variety of indications for hormonal therapy can maximize treatment for a better outcome.

 

 

References

1. Can Fam Physician. 2012 Dec;58(12):e757–60.

2. J Midwifery Womens Health. 2012 Nov-Dec;57(6):585-92.

3. Obstet Gynecol. 2009;114:1428-31.

4. Semin Cutan Med Surg. 2008 Sep;27(3):188-96.

5. Pediatr Rev. 2008;29(11);386-97.

6. J Eur Acad Dermatol Venereol. 2005 Mar;19(2):163-6.

7. Obstet Gynecol. 2005 Sep;106(3):492-501.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures.

 

Arguably, the introduction of the birth control pill has transformed female health more than any other drug in modern medicine. Although many of us practicing now do not know life without it, its history is not that long.

“The Pill” – as it is often referred to – was introduced in May of 1950.1 At that time, prevention of pregnancy was not listed as an indication, and promoting birth control was politically, socially, and legally unacceptable. In fact, the Comstock Law prohibited public discussion and research about contraception.1 Therefore, when the birth control pill was introduced, it was for cycle control and for married women only. It was not indicated for use as contraception in the United States until 1960.

Since that time, the birth control pill has evolved dramatically, not only in its formulation but in its indications as well. As pediatricians, we do not always find it easy to discuss with parents hormonal regulation and starting a patient on the birth control pill, particularly when it will not be used for contraception. There are many fears about using hormonal control, but there are many useful indications that improve the health and well-being of the pediatric patient.

Menorrhagia and dysmenorrhea are likely the most common reasons that hormonal therapy is started in adolescence. Beginning with the lowest estrogen dose to reduce side effects is prudent, adjusting accordingly if side effects should occur. Breakthrough bleeding is a common side effect that usually improves over time. Patients should continue treatment for at least 3 months before deciding if treatment is effective or not. If breakthrough bleeding continues, increasing the estrogen component or changing to a triphasic pill might reduce bleeding.

Dr. Francine Pearce
Primary or secondary amenorrhea – no menarche by the age of 15 years or the cessation of menses for greater than 3 months – is common in adolescence for a variety of reasons. Excessive sports, poor diet, and stress tend to contribute to the onset of primary or secondary amenorrhea; polycystic ovary syndrome is another possible cause. Serum studies including HCG, FSH, prolactin, and TSH help rule out other causes that may need to be addressed. Administering norethindrone acetate 5-10 mg for 5-10 days will usually lead to bleeding.

For a child with mental or significant physical disabilities, suppression of ovulation to prevent a menstrual cycle is very useful. Extended regimens can help to completely suppress ovulation, thereby avoiding withdrawal bleeding. There is anxiety about extended regimens, but there is no greater risk with using hormonal therapy continuously vs. intermittently.2 In fact, using it continuously reduces many of the unwanted side effects associated with the use of oral contraceptive pills (OCPs), for example, heavy bleeding, headaches, and nausea. Complete suppression is difficult, but the odds are better with continuous treatment. Using monophasic OCPs for 42-63 days on and 4-7 days off can be tried. The benefit of using monophasic pills is if a dose is missed, it is easy to make it up by just taking an extra pill. Companies have come out with extended-regimen packs, for example, Seasonale, Seasonique, Quartette, and Lybrel. There now is a chewable pill known as Femcon Fe, which would be useful in those patients who are not able to swallow pills.

©areeya_ann/Thinkstock.com
Progestin-only regimens can be given as a pill (norethindrone acetate) or by injection (Depo-Provera [medroxyprogesterone]). Some important considerations for the disabled patient is that these are associated with more weight gain, which could be problematic for the patient who requires assistance. Another consideration is that progestin-only pills must be taken at the same time every day, and can be associated with increased acne. Breakthrough bleeding is also more common with progestin-only regimens, but adjusting the Depo-Provera regimen to a 10-week schedule reduces the breakthrough bleeding after 4-6 months.3

Another indication for OCPs in the adolescent patient is acne. Although the exact mechanism is not completely understood, estrogen does decrease sebum by reducing the size of the gland4, and, therefore, all OCPs can reduce acne. Norgestimate combinations have the highest androgen to progesterone binding ratio, so they are more effective than OCPs that do not. A newer progestin, drospirenone, is a 17 alpha-spironolactone derivative that produces antiandrogenic activity.5 When used in a combination OCP, acne control appears to be even greater. Hormonal therapy should be considered whenever there has been limited improvement with topical treatment or if acne breakouts are associated with the onset of menses.

Another consideration is to add spironolactone 100 mg by mouth daily to the regimen. Studies have shown it can be safely used in women to reduce acne.6 Patients should be monitored frequently for hyperkalemia, and it should not be used in patients who are already pregnant.4 Lab work should be done to rule out other causes of hyperandrogenism; lab tests would include serum testosterone, androstenedione, dehydroepiandrosterone, sex hormone–binding globulin, and prolactin.4

Premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) – which is the onset of depression, irritability, or anxiety in the second half of the menstrual cycle and remits with the onset of the menstrual cycle – also can be treated with hormonal therapy. This can be particularly helpful in teens with depression, as well as in those who are on treatment without significant resolution. PMS/PMDD appears to be best regulated with OCPs containing drospirenone,7 and using either a shortened course of the placebo phase or a continuous regimen appears to be the most beneficial.

Regardless of the indication for hormonal therapy, the initiation and management are essentially the same. Initiation can be on the first day of the menstrual cycle, on the Sunday after, or at the time of the visit. Initiation midcycle may result in breakthrough bleeding, but that will likely resolve over the next 3 months. No lab tests are required to start hormonal therapy, except for an HCG to rule out pregnancy. Weight and blood pressure should be documented so they can be monitored on follow-up visits. A detailed verbal explanation along with a handout should be provided on proper administration and side effects. Contraindications for the use of OCPs can be found on the Centers for Disease Control and Prevention’s website under medical criteria for the use of contraceptives.

Educating families and patients on their options for hormonal therapy can be life changing. Detailed questions about the menstrual cycle should be asked at every visit, and understanding the wide variety of indications for hormonal therapy can maximize treatment for a better outcome.

 

 

References

1. Can Fam Physician. 2012 Dec;58(12):e757–60.

2. J Midwifery Womens Health. 2012 Nov-Dec;57(6):585-92.

3. Obstet Gynecol. 2009;114:1428-31.

4. Semin Cutan Med Surg. 2008 Sep;27(3):188-96.

5. Pediatr Rev. 2008;29(11);386-97.

6. J Eur Acad Dermatol Venereol. 2005 Mar;19(2):163-6.

7. Obstet Gynecol. 2005 Sep;106(3):492-501.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures.

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