September 2020 Clinical Advisor

A PEER-REVIEWED FORUM FOR NURSE PRACTITIONERS

NEWSLINE

■■ Adults With Diabetes ■■ PAs and Colonoscopies ■■ LGBT Health Outcomes ■■ Rapid Influenza Test ■■ Telemedicine for Asthma ■■ Pain in Older Patients ■■ Large E-Cigarette Study LEGAL ADVISOR

Is an Overheard Murder Confession Privileged?

FEATURE

How to Prepare Patients for the New Influenza Season During COVID-19

DERMATOLOGY CLINIC

Growing Blood Vessels on the Tongue and Lips Salary Survey Results of the 2020 NP & PA Salary Survey See page 36

|

SEPTEMBER 2020

| www.ClinicalAdvisor.com

CENTRALIZED PAIN DISORDER

Spotlight on Fibromyalgia: Updates on Diagnosis and Clinical Management Fibromyalgia affects 2% to 4% of the adult population.

Director Nikki Kean nikki.kean@haymarketmedia.com Associate editor Madeline Morr

FROM THE DIRECTOR

Production editor Kim Daigneau Group creative director Jennifer Dvoretz Senior production manager Krassi Varbanov Director of audience insights Paul Silver National sales manager Alison McCauley, 973.224.6414 alison.mccauley @ haymarketmedical.com Associate account manager Michael Deverin, 732.343.4921 michael.deverin@haymarketmedia.com Publisher Kathleen Hiltz, 201.774.1078 kathleen.hiltz@haymarketmedia.com Vice president, content, medical communications Kathleen Walsh Tulley General manager, medical communications Jim Burke, RPh President, medical communications Michael Graziani CEO, Haymarket Media, Inc. Lee Maniscalco All correspondence to: The Clinical Advisor 275 7th Avenue, 10th Floor, New York, NY 10001 For advertising sales, call 646.638.6085.

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Copyright © 2020

As the autumn season descends upon us, it is hard to believe that the United States has more than 6 million confirmed cases of COVID-19.

Although we had hoped “the curve” would have plateaued and begun to wane over the summer, we experienced the opposite. As states lifted their stay-at-home orders, reopened businesses, and relaxed social distancing rules, the number of cases exploded and the virus spread throughout the South, Southwest, and across the heartland.

Luckily, many states were able to pivot quickly and reintroduce lockdown orders, which seemed to have had a positive effect on lowering the number of new cases in the majority of states, according to the Johns Hopkins Coronavirus resource center. At the time of this writing, only 8 states were in the “red,” indicating an increase in cases over the past week. Florida has seen a dramatic decline in new cases — down from a peak of 15,300 new cases on July 12.

This issue features an article written by Jessica Kovalchick, RPA-C, called How to Prepare Patients for the New Influenza Season During COVID-19. The story highlights the differences in clinical presentation of COVID-19, influenza, and upper respiratory infections. Interestingly, the precautions Americans took to stall the spread of COVID-19, starting in mid-March, also shortened last year’s flu season by 5 to 6 weeks, saving tens of thousands of lives.

However, if stay-at-home orders are lifted and children return to school, these measures may not be effective at preventing a serious influenza season this year, leaving an already overwhelmed health care system struggling with 2 epidemics.

This month we publish our annual NP/PA Salary Survey. The survey was conducted at the beginning of June 2020 and includes responses from 1373 nurse practitioners (NPs) and 489 physician assistants (PAs). In the prior year (June 2019-June 2020), the majority of respondents noted that their average salary had either increased or remained the same.

Although the full effect of COVID-19 may not be reflected in this survey, the pandemic certainly has left its mark. When we asked our readers if the pandemic has had an impact on their income, 30% of NPs and 13% of PAs said they have experienced a reduction in salaries.

I hope you enjoy your issue, and stay safe!

Nikki Kean, Director The Clinical Advisor www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • JULY/AUGUST 2020 5

© JJAYO / GETTY IMAGES

Preparing for an Uncertain Fall Season

Assistant editor Michelle Lampariello

CONTENTS SEPTEMBER 2020

NEWS 10

Newsline ■■Caring for Older Adults With Diabetes During COVID-19 ■■PAs Perform Colonoscopies on Par With Specialists ■■LGBT Health Outcomes Improve Through Intervention ■■Novel Rapid Influenza Diagnostic Test Shows Good

Sensitivity, Specificity ■■And more

10 Added care needed for older adults

FEATURES 9 How to Prepare Patients for the New Influenza 1 Season During COVID-19 Vaccination more important than ever to avoid dual COVID-19 and flu pandemics.

9 Spotlight on Fibromyalgia: Updates on Diagnosis 2 and Clinical Management Management of fibromyalgia pain differs from other conditions.

19 Experts predict dual pandemics

36

Salary Survey NP/PA 2020 Salary Survey results are in. See how you compare.

DEPARTMENTS 8

41 45 Growth on patient with osteoarthritis

49 Overheard conversation at heart of case

Web Roundup A summary of our most recent opinion, news, and multimedia content from ClinicalAdvisor.com.

Dermatology Clinic ■■Hyperpigmented Patch With Hair Growth on Chest ■■Growing Blood Vessels on the Tongue and Lips

45

Dermatologic Look-Alikes ■■Nodules on Hands and Feet

49

Legal Advisor What Is Confidential, Privileged Information?

Follow us on Twitter @ClinicalAdvisor

MORE WAYS TO FIND US!

Like us on Facebook facebook.com/TheClinicalAdvisor Visit us on the web ClinicalAdvisor.com Download the app ClinicalAdvisor.com/App

www.ClinicalAdvisor.com

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EXCLUSIVE TO THE WEB AT

ClinicalAdvisor.com

NEWS ClinicalAdvisor.com/News

CLINICAL CHALLENGE ClinicalAdvisor.com/CaseStudy

Upper Airway Stimulation Improves Sleep Apnea

Brady Pregerson, MD Case Study: Gunshot Wound to the Thigh A 32-year-old man presents for treatment of a gunshot wound above the knee on his left thigh.

His vital signs are normal except for high blood pressure and elevated pulse, which improved following the administration of fentanyl.

Read the full case here: ClinicalAdvisor.com/CaseSep20

The burden of both objective and subjective obstructive sleep apnea improved more in patients who received upper airway stimulation compared with those who did not.

Fecal Transplant Treats Recurrent C difficile Infection in Patients With Cirrhosis In an observational study, researchers investigated the safety of fecal microbiota transplant in 63 patients with Clostridioides difficile and liver cirrhosis.

THE WAITING ROOM

Official Blog of The Clinical Advisor

The Women’s Preventive Services Initiative (WPSI) recommends screening for anxiety and depression to improve earlier detection and treatment to enhance the function and overall well-being of patients.

Menopausal Hormonal Therapy May Cut Urinary Tract Infections Women taking estrogen therapy had high levels of lactobacilli in their urine, whereas women not taking estrogen or with naturally low estrogen had low or undetectable levels.

ClinicalAdvisor.com/WaitingRoom Jim Anderson, MPAS, PA-C, DFAAPA NCCPA Recertification Pilot Program Although the NCCPA has replaced the existing recertification exam, some PAs feel as though the pilot examination program does not sufficiently replace the old exam.

MY PRACTICE ClinicalAdvisor.com/MyPractice

SARS-CoV-2 Antibodies Detected in 13.7% of New York City HCPs The antibody rates were similar between health care workers and adults randomly tested in New York State.

8 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

Reinventing Primary Care: Lessons Learned From the COVID-19 Pandemic The CDC’s framework created to address the influenza pandemic of 2014 is an efficient structure for primary care practices to implement for future pandemics following COVID-19.

IMAGES: MIDDLE, BOTTOM: © GETTY IMAGES

Screening for Anxiety, Depression in Women

Advisor Dx Interact with your peers by viewing the images and offering your diagnosis and comments. To post your answer, obtain more clues, or view similar cases, visit ClinicalAdvisor.com/AdvisorDx. Learn more about diagnosing and treating these conditions, and see how you compare with your fellow colleagues.

Check out some of our latest cases below!

DERM DX

Papules and Plaques on the Posterior Neck A 24-year-old man is referred for evaluation of a rash on his neck, which the patient first noted approximately 2 years ago. He complains of intermittent tightness, pain, and drainage associated with the rash. Examination reveals multiple firm papules and plaques on his posterior scalp and neck.

CAN YOU DIAGNOSE THIS CONDITION?

• Cutis rhomboidalis nuchae • Pemphigus vegetans • Acne keloidalis nuchae • Scrofuloderma ● See the full case at ClinicalAdvisor.com/DermDx_Sep20

In partnership with

ORTHO DX

TheJopa.org

Journal of Orthopedics for Physician Assistants

Shoulder Pain After Humerus Fracture A 78-year-old woman presents with left shoulder pain. Two years ago, the patient sustained a proximal humerus fracture on the left side. Her symptoms have gradually increased over the past 6 months.

Radiograph of the shoulder shows advanced avascular necrosis of the proximal humerus; the glenoid cavity appears to be intact.

WHAT IS THE BEST NEXT STEP IN TREATMENT?

• Core decompression • Humeral head resurfacing • Hemiarthroplasty • Total shoulder replacement ● See the full case at ClinicalAdvisor.com/OrthoDx_Sep20

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 9

© SANJERI / GETTY IMAGES

Newsline

Older adults need more help during COVID-19.

Caring for Older Adults With Diabetes During COVID-19 BECAUSE OLDER ADULTS with diabetes are an at-risk population for encountering numerous challenges during the COVID-19 pandemic, it is important to support them and their needs during this time. In a guidance statement published in JAMA Internal Medicine, clinicians published their thoughts on how to optimize care for patients with diabetes aged ≥70 years during the COVID-19 pandemic.

The pandemic may affect older patients’ ability to manage their diabetes in both direct and indirect ways, the authors noted. Difficulties in receiving care through telemedicine, changes to their daily routine, and financial constraints can impact a patient’s or their caregiver’s ability to properly manage their diabetes.

Sarah L. Sy, MD, and Medha N. Munshi, MD, of the Joslin Diabetes Center in Boston, advised that clinicians should simplify their patients’ diabetes treatment

plans to address a variety of pandemicrelated complications. Some older patients may struggle with uploading data from their glucometers, continuous glucose monitors, and/or insulin pumps to computer applications, while some do not have access to a computer at all.

This does not indicate, however, that clinicians should dismiss a missed telemedicine visit from a geriatric patient under the assumption that they were unable to access the necessary tools, according to the authors. A missed telemedicine visit could be indicative of crises like a fall or episode of hypoglycemia, and clinicians should contact the patient via phone call or reach out to the patient’s family.

The authors proposed that especially for high-risk patients, such as those with type 1 diabetes or with recurrent hypoglycemia, prioritizing goals and providing repeated education under a streamlined

10 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

treatment plan may help patients be more successful in managing their diabetes.

Simplified treatment plans, consolidated medicines, and ensuring that patients have a sufficient supply of prescription refills and additional tools to manage their diabetes may also help them reduce face-to-face interactions with caregivers, preventing increased potential exposure to COVID-19.

Due to frequent COVID-19 outbreaks in nursing homes, some families have chosen to remove their relative from the facility and care for them in their residence. The authors suggested clinicians establish communication with the patient’s family to ensure that they are equipped to properly care for the patient.

The pandemic has the potential to affect patients’ access to diabetes-friendly food; patients may struggle to access grocery stores or afford certain foods due to financial constraints associated with the pandemic.The authors proposed that instead of striving for optimal nutrition, clinicians should advise their patients to eat regular meals, spread carbohydrate intake throughout the day to avoid large blood glucose spikes, and perform light exercise at home, including indoor walking for 10 minutes 3 times per day or strength training with resistance bands or household items.

While the pandemic poses a threat to the physical health of older adults with diabetes, it may affect a patient’s mental health in a similar fashion. Clinicians should encourage patients to communicate with their friends and family through virtual channels to maintain social connections whenever possible.

Screening patients and their caregivers for depression and referring them to a mental health colleague, if needed, should be a significant marker of overall care.

Coming Soon A weekly contraceptive patch

THAT IS PURPOSEFULLY

designed for her

INTRODUCING TWIRLA® ­­— the first novel birth control patch approved in nearly 20 years TWIRLA.COM

INDICATION AND USAGE TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Limitations of Use: Consider the reduced effectiveness of TWIRLA in women with a BMI ≥25 to <30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥30 kg/m2.

Not actual size.

IMPORTANT SAFETY INFORMATION WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 kg/m2 Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use.

This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.

Contraindicated in Women with a BMI ≥30 kg/m2 TWIRLA is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events (VTEs).

Please see additional Important Safety Information on next page and Brief Summary of full Prescribing Information.

102788_009_twirla_hcp_soon_clinadv_fi5.indd 1

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IT’S TIME TO

Reshape your expectations The Twirla® (levonorgestrel and ethinyl estradiol) transdermal system allows you to offer your patients a combined hormonal contraceptive option that features:

A NONINVASIVE METHOD

A LOWER ESTROGEN DOSE

without the need for same-time-every-day dosing

than the only other patch1

A DIVERSE STUDY POPULATION closely representative of the

A pivotal trial with

demographics of women across the US2

Made with proprietary patch technology, designed with a WOVEN,

FLEXIBLE FABRIC

Learn more about Twirla at

TWIRLA.COM

IMPORTANT SAFETY INFORMATION (con’t) CONTRAINDICATIONS TWIRLA is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic disease, including women with a B MI ≥30 kg/m2; headaches with focal neurological symptoms, migraine with aura, women over 35 years of age with any migraine headache; liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis, or liver disease; undiagnosed abnormal uterine bleeding; pregnancy; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; hypersensitivity to any components of TWIRLA; and use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir.

WARNINGS AND PRECAUTIONS • Thromboembolic Disorders and Other Vascular Conditions – Women are at increased risk for a VTE when using TWIRLA. ° Stop TWIRLA if an arterial or VTE occurs. ° Stop TWIRLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. ° Discontinue TWIRLA during prolonged immobilization and, if feasible, stop TWIRLA at least 4 weeks before and through 2 weeks after major surgery. ° Start TWIRLA no earlier than 4 weeks after delivery in women who are not breast-feeding. ° Before starting TWIRLA, evaluate any past medical history or family history of thromboembolism or thromboembolic disorders and consider whether history suggests inherited or acquired hypercoagulopathy.

Arterial Events – CHCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke, particularly among older women (>35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity.

Please see additional Important Safety Information on next page and Brief Summary of full Prescribing Information.

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IMPORTANT SAFETY INFORMATION (con’t) WARNINGS AND PRECAUTIONS (con’t) • Liver Disease – Discontinue TWIRLA if jaundice develops.

• Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment – Discontinue TWIRLA prior to starting therapy with the hepatitis C combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. TWIRLA can be restarted approximately 2 weeks following completion of treatment with that combination drug regimen.

• Hypertension – Monitor blood pressure at routine visits and stop TWIRLA if blood pressure rises significantly. An increase in blood pressure has been reported in women using CHCs, and this increase is more likely in older women with extended duration of use.

• Gallbladder Disease – Studies suggest CHCs increase the risk of developing gallbladder disease and may also worsen existing gallbladder disease.

• Adverse Carbohydrate and Lipid Metabolic Effects – ° TWIRLA may decrease glucose tolerance. Carefully monitor prediabetic and diabetic women who are using TWIRLA. ° Consider alternative contraception for women with uncontrolled dyslipidemia. TWIRLA may cause adverse lipid changes. Women with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using TWIRLA, which may increase the risk of pancreatitis.

• Headache – If a woman using TWIRLA develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue TWIRLA as indicated. Consider discontinuation of TWIRLA if there is any increased frequency or severity of migraines during CHC use (which may be prodromal of a cerebrovascular event).

• Bleeding Irregularities and Amenorrhea – Women using TWIRLA may experience unscheduled bleeding, especially during the first 3 months of use, or experience absence of scheduled bleeding. If bleeding persists or occurs after previously regular cycles on TWIRLA, or if scheduled bleeding does not occur, evaluate for causes such as pregnancy or, in the case of unscheduled bleeding, malignancy.

• Other Warnings and Precautions – Other warnings and precautions include depression, cervical cancer, increased serum concentrations of binding globulins, hereditary angioedema, and chloasma.

ADVERSE REACTIONS The following serious adverse reactions occurred in <1% of women who received TWIRLA: cholelithiasis, cholecystitis, major depression, suicidal ideation, appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis. A total of 4 VTEs in TWIRLA-treated patients were identified in the phase 3 clinical trial. The most common adverse reactions (≥2%) in clinical trials for TWIRLA are application site disorders, nausea, headache, dysmenorrhea, and increased weight.

Patients should be counseled that TWIRLA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

DRUG INTERACTIONS Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of TWIRLA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with TWIRLA. This is not a comprehensive list of safety information related to TWIRLA. Please see full Prescribing Information, including BOXED WARNING. To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

References: 1. Xulane [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals; 2020. 2. Humes KR, Jones NA, Ramirez RR. Overview of Race and Hispanic Origin: 2010.

Washington, DC: US Census Bureau; 2011.

TWIRLA is a registered trademark of Agile Therapeutics, Inc. © 2020 All Rights Reserved.

PM-US-TW-0045 08/20

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TWIRLA® (levonorgestrel and ethinyl estradiol) transdermal system BRIEF SUMMARY (For full Prescribing Information, see package insert) Women should be informed that this product does not protect against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 kg/m2 See full prescribing information for complete boxed warning • TWIRLA is contraindicated in women over 35 years old who smoke.

Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use.

• TWIRLA is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events.

INDICATION AND USAGE

TWIRLA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Limitations of Use

Consider TWIRLA’s reduced effectiveness in women with a BMI ≥25 to <30 kg/m2 before prescribing.

CONTRAINDICATIONS TWIRLA should not be used in women with any of the following conditions: • At high risk for arterial or venous thromboembolic events.

• Headaches with focal neurological symptoms, migraine headaches with aura • Women over 35 years of age with any migraine headache [see Warnings and Precautions] • BMI ≥30 kg/m2 • Liver tumors (benign or malignant), acute viral hepatitis, or severe (decompensated) cirrhosis, or liver disease • Undiagnosed abnormal uterine bleeding • Pregnancy, given there is no reason to use CHCs during pregnancy • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past • Hypersensitivity to any components of TWIRLA. Observed reactions include itching and irritation at the TDS application site • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations

WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Conditions

Stop TWIRLA if an arterial or venous thromboembolic event occurs.

Stop TWIRLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

Discontinue TWIRLA during prolonged immobilization and resume treatment based on clinical judgement. If feasible, stop TWIRLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start TWIRLA no earlier than four weeks after delivery in women who are not breast-feeding.

The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week.

Before starting TWIRLA, evaluate any past medical history or family history of thromboembolism or thromboembolic disorders. Consider whether the history suggests an inherited or acquired hypercoagulopathy.

Liver Disease

Elevated Liver Enzymes Discontinue TWIRLA if jaundice develops. Acute liver test abnormalities may necessitate the discontinuation of CHC use until the liver tests return to normal and CHC causation has been excluded.

Liver Tumors CHCs increase the risk of hepatic adenomas. Rupture of hepatic adenomas may cause death from abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) CHC users.

Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

In clinical trials with Hepatitis C combination drug regimens containing ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir, ALT elevations >5 times the upper limit of normal (ULN), including some cases >20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as CHCs. Discontinue TWIRLA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. TWIRLA can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

Hypertension

For all women, including those with well-controlled hypertension, monitor blood pressure at routine visits and stop TWIRLA if blood pressure rises significantly. An increase in blood pressure has been reported in women using CHCs, and this increase is more likely in older women with extended duration of use.

102788_009_twirla_hcp_soon_clinadv_fi5.indd 4

Age-Related Considerations

The risk for cardiovascular disease and prevalence of risk factors for cardiovascular disease increase with age. Consider the presence of underlying risk factors that may increase the risk of cardiovascular disease or VTE, particularly before initiating a CHC for women over 35 years, such as; hypertension, diabetes, dyslipidemia, obesity.

Gallbladder Disease

Studies suggest an increased risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease. A past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis.

Adverse Carbohydrate and Lipid Metabolic Effects

Hyperglycemia TWIRLA may decrease glucose tolerance. Carefully monitor prediabetic and diabetic women who are using TWIRLA. Dyslipidemia Consider alternative contraception for women with uncontrolled dyslipidemia. TWIRLA may cause adverse lipid changes. Women with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using TWIRLA, which may increase the risk of pancreatitis.

Headache

If a woman using TWIRLA develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue TWIRLA if indicated. Consider discontinuation of TWIRLA if there is any increased frequency or severity of migraines during use (which may be prodromal of a cerebrovascular event).

Bleeding Irregularities and Amenorrhea

Unscheduled and Scheduled Bleeding and Spotting Women using TWIRLA may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If bleeding persists or occurs after previously regular cycles on TWIRLA, evaluate for causes such as pregnancy or malignancy.

Amenorrhea and Oligomenorrhea Women who use TWIRLA may experience absence of scheduled (withdrawal) bleeding, even if they are not pregnant.

If scheduled bleeding does not occur, consider the possibility of pregnancy. If the woman has not adhered to the prescribed dosing schedule, consider the possibility of pregnancy at the time of the first missed period and perform appropriate diagnostic measures. If the woman has adhered to the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy.

After discontinuation of TWIRLA, amenorrhea or oligomenorrhea may occur, especially if these conditions were pre-existent.

Depression

Carefully observe women with a history of depression and discontinue TWIRLA if depression recurs to a serious degree. Data on the association of CHCs with onset of depression or exacerbation of existing depression are limited.

Cervical Cancer

Some studies suggest that CHCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. There is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.

Effect on Binding Globulins

The estrogen component of TWIRLA may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin.

Hereditary Angioedema

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Chloasma

Chloasma may occur with TWIRLA use, especially in women with a history of chloasma gravidarum. Advise women with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while using TWIRLA.

ADVERSE REACTIONS CLINICAL TRIAL EXPERIENCE

The safety of TWIRLA was evaluated in a 12-month, multicenter, open-label, single-arm clinical trial conducted in the United States. Women applied TWIRLA (120 mcg LNG/30 mcg EE) for 13 28-day treatment cycles. One treatment cycle is defined as three consecutive weeks that one TWIRLA TDS is applied for seven-day wear followed by one week that TWIRLA is not applied.

The most common adverse reactions that occurred in ≥2% of the 2,031 women that used TWIRLA were: application site disorder (6.2%), nausea (4.1%), headache (3.6%), dysmenorrhea (2.3%) and weight increased (2.0%).

Venous Thromboembolic Events (VTEs) A total of four VTEs (including pulmonary embolism and deep vein thrombosis) in TWIRLA-treated patients were identified in the clinical trial. Of these, all were in women with a BMI ≥30 kg/m2.

Other Serious Adverse Reactions The following serious adverse reactions occurred in <1% of women who received TWIRLA: cholelithiasis, cholecystitis, major depression, suicidal ideation, appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis.

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DRUG INTERACTIONS Effects of Other Drugs on Combined Hormonal Contraceptives

CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of CHCs. Concomitant use of CHCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of CHCs, potentially diminishing effectiveness. Counsel women to use a backup or alternative method of contraception when enzyme inducers are used with TWIRLA. Significant increases and/or decreases in systemic exposure of the estrogen and or progestin have been noted when CHCs are co-administered with some HIV protease inhibitors, HCV protease inhibitors, and some non-nucleoside reverse transcriptase inhibitors.

Effects of Combined Hormonal Contraceptives on Other Drugs

Concomitant use of CHCs with lamotrigine, acetaminophen, morphine, salicylic acid, and temazepam may decrease systemic exposure of these drugs. Concomitant use of CHCs with thyroid hormone replacement therapy or corticosteroid replacement therapy may increase systemic exposure of thyroid-binding and cortisol-binding globulin. Concomitant of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole), may increase systemic exposure of these drugs.

USE IN SPECIFIC POPULATIONS Pregnancy

Discontinue TWIRLA if pregnancy occurs. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects following exposure to CHCs before conception or during early pregnancy.

Lactation

Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding women. This reduction can occur at any time but is less likely to occur once breastfeeding is well established. Advise the nursing woman to use another method of contraception until she discontinues breastfeeding. No studies have been conducted on the use of TWIRLA in breastfeeding women.

OVERDOSAGE

There have been no reports of serious adverse outcomes from overdose of CHCs, including ingestion by children. Overdose may cause uterine bleeding in women and nausea. In case of suspected overdose, the TWIRLA TDS should be removed and symptomatic treatment given.

PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use).

• Advise the woman that cigarette smoking increases the risk of serious cardiovascular events from CHC use. Women who are over 35 years old and smoke should not use TWIRLA. • Advise the woman that an increased risk of VTE compared to non-users of CHCs is greatest after initially starting a CHC or restarting (following a 4-week or greater interruption in intake) the same or a different CHC. • TWIRLA is not to be used during pregnancy. Instruct the woman to stop TWIRLA if pregnancy is confirmed during treatment.

• Advise the woman that TWIRLA does not protect against HIV infection and other sexually transmitted infections.

• Apply one TDS weekly for 3 weeks followed by one TDS free week. Instruct women what to do in the event TDS change is missed.

• Postpartum women who have not yet had a period when they start TWIRLA need to use an additional method of contraception until they have used the TDS for one week.

• A back-up or alternative method of contraception is needed when enzyme inducers are used with TWIRLA. • TWIRLA may reduce breast milk production. This is less likely to occur if breast-feeding is well established. When possible, nursing women should use other methods of contraception until they have discontinued breast-feeding.

• Amenorrhea may occur. Advise the woman to contact a health care provider in the event of amenorrhea in two or more consecutive cycles or in case of symptoms of pregnancy such as morning sickness or unusual breast tenderness.

• Resumption of fertility after discontinuing TWIRLA is expected.

• Advise women to avoid frequent or prolonged water exposure and to avoid use of large amounts of body lotions or oils. Advise women to check the TDS for partial or complete TDS detachment daily and after frequent or prolonged water exposure.

Manufactured by: Corium International, Inc. 4558 50th Street, SE Grand Rapids, MI 49512 Manufactured for: Agile Therapeutics, Inc. 101 Poor Farm Rd. Princeton, NJ 08540

102788_009_twirla_hcp_soon_clinadv_fi5.indd 5

8/20/20 2:19 PM

Newsline PAs Perform Colonoscopies on Par With Specialists IN AN ANALYSIS of routine colonoscopies, physician assistants (PAs) performed the procedure on par with their physician counterparts, according to a study published in the Journal of the American Academy of Physician Assistants.

Researchers analyzed routine screening colonoscopies performed by 7 gastroenterologists, 5 PAs, and 32 gastroenterology (GI) fellows.The physicians in the study had a median of 15.5 years of experience whereas the PAs had a median of 10.8 years. Overall, cecal intubation was successful in 98.5% of patients with a mean intubation time of 9.9 minutes.

Adenomas were detected in 44.6% of patients, with 13.4% patients having 1 or more adenomas larger than 1 cm.

Only 1 screening colonoscopy revealed colorectal cancer.

In the groups of clinicians with ≤5 years or 6 to 15 years of endoscopy experience, no statistically significant difference was found in mean intubation time between PAs and physicians; however, the group of PAs with >15 years of experience had shorter mean intubation times than

PAs outperformed fellows on multiple measures of colonoscopy quality.

gastroenterologists with similar experience (7.5 min vs 15.6 min).

Colonoscopy withdrawal time was >6 minutes for both attending gastroenterologists and for PAs. No statistically significant differences in adenoma detection rates were identified when compared based on years of experience.

Colonoscopy performance was also examined by provider type. PAs performed significantly better than GI fellows in intubation time (7.8 min vs 13.2 min) and had a notably shorter withdrawal time (9.6 min vs 11.5 min, respectively). No significant difference was found between the intubation time of PAs and attending gastroenterologists (7.8 min vs 8.8 min). PAs, GI fellows, and attending gastroenterologists performed comparably in adenoma detection (46.7%, 43.5%, and 44.2%, respectively).

TRANSFORMING LGBT CARE, a new intervention tool, helped increase quality of visits by creating inclusive environments, collecting sexual orientation and gender identity (SOGI) data, and conducting screening for sexually transmitted infections, according to a study published in Annals of Family Medicine.

“champion,” and 2 or 3 additional staff members. Teams also collaborated with electronic health record (EHR) vendors to improve capturing SOGI and sexual risk data. Clinicians developed scripts for answering patient questions in real time while working with LGBT patient advisory groups.

The intervention resulted in an 86.5% increase in syphilis screening, 109% increase in chlamydia and gonorrhea screening, and 132% increase in HIV screening.

The intervention was implemented in 10 federally qualified health centers (FQHCs), located in both rural and urban areas throughout the United States. Each FQHC assembled a 4- or 5-person team that included 1 quality improvement facilitator, a clinical

The intervention expanded from 10 clinicians at 10 sites to 431 clinicians at 79 clinical sites. FQHCs reported increases in culturally affirming practices including patient pronoun information (42.9% increase), identifying staff m ­ embers who identified as an LGBT liaison (300%

16 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

increase), and new hire training on behavioral health needs for LGBT patients (200% increase). Asking patients SOGI questions increased by 350%.

SOGI data collection increased by 276.3% for 8 of the 10 FQHCs. Prior to the intervention, 23,835 patients (13.5%) had their SOGI information documented; after implementation, 104,583 patients (50.8%) had their SOGI data recorded.

For LGBT patients, the intervention resulted in an 86.5% increase in syphilis screening, 109% increase in chlamydia and gonorrhea screening, and 132% increase in HIV screening.

The willingness of centers to actively participate in a time-intensive intervention without financial compensation suggests that this type of intervention is desirable, the study authors concluded.

© WICKI58 / GETTY IMAGES

LGBT Health Outcomes Improve Through Intervention

Novel Rapid Influenza Diagnostic Test Shows Good Sensitivity, Specificity

© OXFORD SCIENTIFIC / PHOTOLIBRARY / GETTY IMAGES

THE THERAFLU Home FluTest, a novel rapid influenza diagnostic test, demonstrated good sensitivity and specificity for both influenza A and B viruses, according to study results presented at the American Thoracic Society 2020Virtual meeting, held August 5 to 10, 2020.

Rapid influenza diagnostic tests are important for early treatment and control measures, but their use is limited to point of care (POC) settings. According to the Centers for Disease Control and Prevention, there are 13 approved rapid influenza diagnostic tests (antigen detection only) currently on the market for professional use. However, the Home FluTest is currently in development for consumer use.

Therefore, researchers conducted a prospective study across 25 sites in the United States to evaluate the performance of the Theraflu Home FluTest for the detection of influenza A and B viruses. They enrolled 1012 participants between December 2018 and April 2019 who self-administered nasal swabs or performed by caregivers if

A rapid influenza test is under development for use in the office or at home.

participants were aged ≥2 years with influenza-like symptoms.

Key performance values were based on comparison with 3 reference methods: nucleic acid amplification testing, shell viral culture, and a real-time polymerase chain reaction consensus comparator.

In addition, participants completed a questionnaire regarding the ease of use of the Theraflu Home FluTest using a 5-point Likert scale (1=strongly disagree to 5=strongly agree).

In terms of influenza A, the Theraflu Home FluTest compared with the consensus result demonstrated a positive agreement of 87.7% (95% confidence limit [CL], 83.6%-90.9%) and a negative agreement of 98.0% (95% CL, 96.6%98.9%). Meanwhile, for influenza B, the Theraflu Home FluTest compared with the consensus result demonstrated a specificity of 97.9% (95% CL, 98.6%-98.7%).

Because of the small sample size of participants with influenza B (n=12), the researchers conducted a further analysis using 89 archived samples.This analysis demonstrated a sensitivity vs consensus result of 86.3% (95% CL, 74.3%-93.2%).

In the safety data set, 5 participants experienced an adverse event related to nasal swabbing, but none were determined to be serious. Furthermore, ≥95% of participants agreed or strongly agreed that the test was easy to use and that they would feel confident using it at home, according to the usability questionnaire. In addition, 88% agreed or strongly agreed that the nose swab was easy to complete.

“The [Theraflu Home FluTest] should expand opportunities as an aid to rapid influenza detection and management beyond POC settings,” the researchers concluded.

Telemedicine Improves Outcomes in Young Adults With Asthma YOUNG ADULTS with asthma experienced improved clinical outcomes after undergoing virtual care, known as a multi-level electronic medical record (EMR)-integrated smartphone-telemedicine program (TEAMS), according to study results presented at the American Thoracic Society 2020 Virtual meeting.

Researchers sought to examine the effect of TEAMS on patients struggling with asthma care. The virtual care included smartphone asthma symptom monitoring, a telemedicine follow-up, and 1:1 self-management training with a nurse. Patients aged 18 to 44 years (mean age, 33.39 years) were selected from a safety net primary care practice in New York to undergo a 6-month pilot study. The majority of the patients reported having uncontrolled asthma at baseline (80%), most had public insurance (78.8%), and 63.6% were employed with a full/part time job.

The patients underwent an average of 5 separate smartphone visits (range 2-9 visits) that lasted on average a total of 26 minutes. By 3 months, most patients (70%) reported having well controlled asthma and by the 6-month follow-up, 24 of the 30 patients (80%) reported having well controlled asthma.

Improvements in asthma control and asthma quality of life (QoL) more than doubled the minimum important difference, with an increase of 5% in mean FEV1 percent predicted.

Patients reported better asthma control and that the TEAMS intervention positively affected their QoL.

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 17

Newsline Geriatric Patients May Underreport Pain Severity A MORE NUANCED approach to pain management may be warranted in older patients who are hospitalized for rib fractures, according to a study published in JAMA Surgery.

Compared with younger patients with rib fractures, geriatric patients (aged ≥65 years) were almost 4 times more likely to report no pain, and when they did report pain, their pain scores were much lower than their younger counterparts.This finding supports the theory that geriatric patients may underreport pain and may require a lower threshold to escalate analgesic care, reported the authors.

The research team evaluated adult patients admitted for ≥4 days with isolated chest wall injuries at a level I trauma center.The primary outcome was comparison of numerical pain rating scale scores during hospitalization. A total of

A lower pain score threshold for geriatric patients may be prudent.

385 patients were included in the study; 166 of whom were ≥65 years of age.

The geriatric group had more women compared with the non-geriatric group (53% vs 18%). Older patients suffered

more falls and less motorcycle or bicycle injuries than younger patients (falls: 60.2% vs 20%; motorcycle crash: 2.4% vs 21%; and bicycle crashes: 7.8% vs 20.5%, respectively), and had lower injury severity scores (10.4 vs 14, respectively).The geriatric group received fewer opioids per day (oral morphine equivalents: 75.5 mg vs 177.1 mg for non-geriatric patients) but had similar rates of epidural nerve block use as the nongeriatric group.

The adjusted odds ratio for reporting no pain was 3.85 times higher (95% CI, 3.11-4.77) in the geriatric group compared with the non-geriatric group.

Among patients with a pain score ≥1, scores were 15% lower in the geriatric group compared with the nongeriatric group. Patients with isolated rib fractures showed similar results of pain severity.

E-Cigarettes, Marijuana Use Raises Risk for Lifetime Asthma This cross-sectional study comprised 21,532 middle and high school students (5222 with lifetime asthma and 16,310 control individuals), with ages ranging between 12 and 18 years. The students participated in the 2015 and 2017 National

with a 23% to 68% increase in lifetime asthma odds. In addition, e-cigarette use was associated with 1.31 times increased odds of lifetime asthma (95% CI, 1.11-1.54). The combination of e-cigarette use and marijuana use was

Frequent use of e-cigarettes, marijuana, and cigarette smoking was associated with a 23% to 68% increase in lifetime asthma odds.

Youth Risk Behavior Study. Researchers used the self-administered questionnaires to collect information on demographic characteristics, asthma, and use of nicotine vapor products alone or in combination with marijuana use/cigarette smoking.

Frequent use of e-cigarettes, marijuana, and cigarette smoking was associated

18 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

more ­frequently associated with lifetime asthma than e-cigarette use alone.

According to the researchers, these results indicate that continued research is necessary to determine the damaging effects from the dangerous use of e-cigarettes in adolescents in the United States. ■

© LUIS ALVAREZ / GETTY IMAGES

ELECTRONIC cigarette (e-­cigarette) use is associated with lifetime asthma in US adolescents, and may become more damaging when combined with marijuana or cigarette smoking, according to study results presented at the American Thoracic Society 2020 Virtual meeting, held August 5 to 10, 2020.

E-cigarettes are now the most commonly used nicotine products among adolescents in the United States.These products often contain nicotine, flavoring, and other chemicals. Little is known about the combination of e-cigarettes and marijuana use or cigarette smoking. Therefore, researchers examined whether e-cigarette use combined with marijuana or cigarette smoking could increase the risk for lifetime asthma.

FEATURE: JESSICA KOVALCHICK, RPA-C

How to Prepare Patients for the New Influenza Season During COVID-19 The Advisory Committee on Immunization Practices encourages all Americans to receive the flu vaccine between September and October.

© ROGER HARRIS / SCIENCE PHOTO LIBRARY / GETTY IMAGES

Only 45% of adults and 63% of children receive the flu vaccine annually.

E

very influenza season brings with it uncertainty about what strain will predominate and how severe it will be. While much of the world still is focusing on COVID-19, the potential for another serious influenza season can’t be ignored, and the strain on the health care system of 2 epidemics could be severe.1 As the SARS-CoV-2 virus continues to spread across the country, the 2020-2021 influenza season will be particularly challenging.1 Recent influenza seasons have been serious: 2017-2018 was one of the deadliest in decades, with an estimated 61,000 deaths, and 2018-2019 was one of the longest flu seasons, lasting 21 weeks.2 The 2019-2020 influenza season was on a trajectory to be particularly severe, especially for children because of a high prevalence of influenza B cases.3 However, the season ended 5 to 6 weeks earlier than anticipated after control measures were put in place to prevent COVID194; even with the shortened season, the Centers for Disease Control and Prevention (CDC) estimated 34,157 deaths, which was on par with the number of cases from 2018-2019.2,3 Although influenza viruses cannot be controlled directly, there are several measures that can be taken to help mitigate the severity of the influenza season.

Prevention

In March 2019, the World Health Organization (WHO) announced a Global Influenza Strategy for 2019-2030 aimed at “protecting people in all www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 19

INFECTIOUS DISEASE: INFLUENZA AND COVID-19

countries from the threat of influenza.”5 The goals include the prevention of seasonal influenza, the control of spread from animals to humans, and preparation for the next influenza pandemic.5 Many pandemic control measures learned by studying the 1918, 1957, 1968, and 2009 influenza pandemics are being used for COVID-19 and will continue to be used during the influenza season this fall. However, as stay-at-home orders are lifted and children return to school, these measures may not be effective at preventing a serious influenza season.

It is especially important for everyone, especially those at high risk for influenza and COVID-19 infection, to receive an influenza vaccination this season and use nonpharmaceutical prevention strategies, such as frequent hand hygiene, masking, voluntary home isolation for ill people, respiratory etiquette, and frequent cleaning of surfaces.These measures should be followed year-round by everyone, but are especially important during the influenza season, to limit the transmission of infection.6 These interventions are most effective when implemented in combination, for example, hand hygiene and wearing a face covering.7 Immunization Vaccination is the most important measure to protect against influenza and its complications.8 According to the CDC, 45% of adults and 63% of children receive the flu vaccine annually.9 This leaves a large portion of the population at risk for infection.

Increases in the number of people, especially at-risk populations, being vaccinated against the flu would decrease the disease burden on the population and the stress on the health care system.1 This is especially important during the COVID-19 pandemic, which continues to put stress on available health care resources.

The CDC and WHO recommend influenza vaccines for everyone aged ≥6 months, with a special focus on the following high-risk populations and their contacts/caregivers10: • Children aged 6 to 59 months and adults aged ≥50 years • People with chronic pulmonary, cardiovascular (excluding isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders • People who are immunocompromised • Women who are or will be pregnant during the influenza season • Children and adolescents receiving aspirin- or salicylatecontaining medications • Residents of nursing homes and other long-term care facilities • American Indians/Alaska Natives • People who are extremely obese (body mass index ≥40) It is important to remember that children aged 6 months to 8 years require 2 doses of vaccine, given at least 4 weeks apart, their first season receiving a vaccination.10

Several influenza vaccines are available in the United States: standard-dose inactivated influenza vaccine, high-dose ­inactivated influenza vaccine, adjuvanted influenza vaccine, recombinant influenza vaccine, live attenuated influenza vaccine, and cell culture–based inactivated influenza vaccine.

Recommended timing for administration of seasonal influenza vaccine is during September and October.11 However, vaccination should continue as long as viruses are circulating and vaccines are available.10 The Advisory Committee on Immunization Practices does not anticipate a major change in the recommendation or timing of the flu vaccine because of the COVID-19 pandemic and does not recommend early vaccination in July or August against influenza because this can lead to a decreased protection in the later part of the flu season.11 The CDC is working with health care providers and state and local health departments to develop contingency plans on how to vaccinate people against flu without increasing the risk for exposure to COVID-19.11 Two new vaccines have been approved for the 2020-2021 influenza season: quadrivalent high-dose vaccine for use in adults ≥65 years of age (replaces the trivalent high-dose vaccine) and quadrivalent adjuvanted vaccine for use in adults ≥65 years of age (similar to previous trivalent adjuvanted vaccine).10 Both vaccines have been shown to promote a better immune response to the vaccine in adults ≥65 years of age.10 Nonpharmaceutical Interventions Both COVID-19 and influenza are spread primarily through respiratory droplets during close contact.1 Social distancing aims to reduce the frequency of contact and increase the physical distance between people, which reduces person-to-person transmission. For influenza, CDC guidelines recommend at least 3 feet between persons. This guideline applies to apparently healthy individuals as well. Continuing other social distancing measures, such as teleworking and avoiding mass gatherings, also will help decrease the spread of influenza.6 Similar to COVID-19, influenza can be transmitted by people with mild or asymptomatic infections.12 A challenge associated with isolation of potentially infective individuals is the lack of evidence about the duration of infectivity.7 CDC guidelines recommend voluntary isolation until fever is absent for 24 hours or 5 to 7 days after illness onset. Temperatures should be checked in the absence of antipyretic medications.6 Isolation or quarantine of infected and exposed individuals reduces transmission of illness in the community but increases transmission of infection to household contacts.

Models show that an estimated 25% to 40% of H1N1 cases in the 2009 pandemic were attributed to household transmission.13 Voluntary/self-quarantine is preferred over mandatory quarantine because the latter raises ethical concerns about

20 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

freedom of movement and the increased risk for infection among quarantined individuals.7 The continued use of face coverings in public for prevention of COVID-19 also will help limit the spread of influenza. Masks provide a physical barrier for large-particle respiratory droplets when an infected person talks, coughs, or sneezes.Verma and colleagues studied the dispersal of respiratory droplets with and without non-medical face masks.14 Masks perform better when they are well fitted to a person’s face; if not, the respiratory droplets leak from the top and bottom of the mask, in addition to the expected transmission through the mask. A well-fitted multilayer mask made of quilted fabric decreased droplet dispersal to 2.5 inches compared with 8 feet without a mask; 3 feet, 7 inches with a bandana; 1 foot, 3 inches with a folded handkerchief; and 8 inches for an off-the-shelf cone style mask.14 Regardless of mandatory mask requirements, well persons who are at high risk from influenza complications and cannot avoid crowded settings benefit from wearing a mask.6 Presentation

Differentiating between respiratory pathogens can be challenging for primary care providers (Table 1). It can be very difficult to distinguish SARS-CoV-2 and influenza infections,

and these viruses can co-infect a patient.15 COVID-19 also has an extremely variable presentation.All providers will need to have a high clinical suspicion for both illnesses during the flu season this fall.

Patients with influenza typically present with acute onset of fever, cough, headache, muscle and joint pain, severe malaise, fatigue, sore throat, and runny nose.16 The incubation period typically is 2 days but ranges from 1 to 4 days.16 Children with influenza may have vomiting and/or diarrhea.17 Patients with COVID-19 most commonly experience fever, dry cough, and fatigue; they may also have body aches, sore throat, diarrhea, conjunctivitis, headache, loss of taste or smell, rash on skin, or discoloration of fingers or toes.18 COVID-19 tends to have a more gradual onset, with a mean incubation period of 5 days and a range of 1 to 14 days.19 Studies have shown that both patients with influenza and COVID-19 present with fever, cough, and dyspnea.20 Fever tends to be more severe in patients with influenza, and some patients with COVID-19 do not develop fevers, even when their illness has advanced to pneumonia.21,22 Gastrointestinal symptoms have been found to be much more prevalent in patients with COVID-19 compared with those with Continues on page 27

TABLE 1. Characteristics of COVID-19, Influenza, and Upper Respiratory Infections COVID-19

Influenza

Upper Respiratory Infection

Incubation

1-14 days (median 5)

1-4 days

1-3 days

Onset

Gradual

Rapid

Gradual

Fever

Common

Common (severe)a

Rare

Cough

Common

Common

Mild-moderate

Fatigue

Common (severe)a

Common

Sometimes

Dyspnea

Common

Sometimes

Mild

Myalgias

Sometimes

Common

Slight

Headache

Sometimes

Common

Rare

Decreased appetite

Sometimes

Common

Sometimes

Chills

Sometimes

Common

Rare

Diarrhea

Sometimesa

Sometimes

Rare

Rhinorrhea/congestion

Sometimes

Sometimes

Common

Sore throat

Sometimes

Sometimes

Common

a

Indicates symptoms that may help distinguish influenza and COVID-19

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 21

INFECTIOUS DISEASE: INFLUENZA AND COVID-19

influenza.20-22 Another potential differentiating factor is that fatigue tends to be more severe with COVID-19.20,22 Patients infected with SARS-CoV-2 can be co-infected with other respiratory pathogens. A study by Kim et al demonstrated that 20.7% of SARS-CoV-2–positive patients also were positive for 1 or more additional respiratory pathogens.15 Therefore, diagnosis of 1 respiratory pathogen does not rule out an infection with another. Although general testing for respiratory pathogens may not be beneficial because it does not rule out the coronavirus, testing for influenza is indicated because a positive test will affect the treatment plan.15

POLL POSITION Which of the following patient group is not at high risk for influenza?

■ Children and adolescents receiving aspirin- or salicylatecontaining medications ■ American Indians/Alaska Natives ■ Patients aged 5 to 65 years

Treatment

According to the CDC and WHO, for patients with uncomplicated seasonal influenza, treatment should focus on management of symptoms, such as fever.16,23 The CDC recommends antiviral treatment as early as possible for patients who are hospitalized; have severe, complicated, or progressive illness; or are at higher risk for influenza complications. This includes patients with exacerbations of underlying chronic medical conditions.23 Treatment also can be considered for symptomatic patients with household contacts at high risk for complications.24 The initiation of antiviral medications should not be delayed pending laboratory confirmation of suspected infections. Ideally, treatment should be started within 48 hours of symptom onset but it may be considered later in the course of illness based on the patient’s presentation.23 Studies have shown that early treatment of influenza with antiviral medications reduces duration of symptoms, risk for complications (bronchitis, otitis media, pneumonia), and hospitalizations.24 It may decrease mortality among high-risk populations.24 According to the WHO and Infectious Diseases Society of America (IDSA), treatment should be given for a minimum of 5 days, but it can

■ People who are extremely obese (body mass index ≥40)

8.74%

21.88%

45.94%

23.44%

For more polls, visit ClinicalAdvisor.com/Polls.

be continued beyond that until there is satisfactory clinical improvement.16,24 The CDC recommends 4 FDA-approved antiviral medications for outpatient treatment of influenza: oral oseltamivir, inhaled zanamivir, intravenous peramivir, and oral baloxavir (Table 2).

Oseltamivir is the recommended antiviral for patients with severe, complicated, or progressive illness, as well as pregnant women.

In the United States, rates of resistance to these medications are currently low.During influenza season, monitor the CDC for guidance on influenza resistance to the current circulating viruses because this may affect treatment plans.23 The WHO and IDSA recommend against the routine use of corticosteroids in the treatment of influenza unless they are indicated for other reasons, such as asthma exacerbation.16,24

TABLE 2. Comparison of FDA-Approved Influenza Treatments Generic

Approved Ages

Not Recommended for Use

Dosing

Adverse Effects

Oseltamivir

≥14 days

N/A

Oral BID x 5 days

Nausea, vomiting, headache, serious skin reactions, and sporadic transient neuropsychiatric events

Zanamivir

≥7 years

People with underlying respiratory disease

Inhalation BID x 5 days

Bronchospasm, sinusitis, dizziness, serious skin reactions, and sporadic transient neuropsychiatric events

Peramivir

≥2 years

N/A

IV single dose

Diarrhea, serious skin reactions, and sporadic transient neuropsychiatric events

Baloxavir

≥12 years

Pregnant or breastfeeding women; severely immunocompromised patients; >2 days after symptom onset

Oral single dose

None more common in clinical trials

N/A, not available; BID, twice a day; IV, intravenous

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INFECTIOUS DISEASE: INFLUENZA AND COVID-19

Corticosteroids have been associated with prolonged viral clearance as well as immunosuppression leading to bacterial or fungal superinfections.16,24

for Disease Control and Prevention website. https://www.cdc.gov/flu/ fluvaxview/coverage-1819estimates.htm. Updated September 26, 2019.

Accessed August 2, 2020.

10. Grohskopf LA, Alyanak E, Broder KR, Walter EB, Fry AM, Jernigan DB.

Conclusion

During the 2020-2021 influenza season, providers will need to keep a broader differential diagnosis for patients with upper respiratory symptoms. COVID-19 and influenza can present very similarly. Even in patients with a positive flu test, COVID-19 must be kept in mind because patients can present with co-infection. Prevention strategies for both illnesses include frequent handwashing, social distancing, and self-quarantine. Encouraging patients to get a flu vaccine is especially important to help decrease the disease burden on our health care system. ■

Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 influenza season. MMWR Recomm Rep. 2019;68(3):1-21.

11. Centers for Disease Control and Prevention. Influenza (flu). Frequently asked influenza (flu) questions: 2020-2021 season. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/season/faq-fluseason-2020-2021.htm. Updated July 28, 2020. Accessed August 2, 2020.

12. Ip DKM, Lau LLH, Leung NHL, et al. Viral shedding and transmission potential of asymptomatic and paucisymptomatic influenza virus infections in the community. Clin Infect Dis. 2017;64(6):736-742.

13. van Gemert C, Hellard M, McBryde ES, et al. Intrahousehold transmission of pandemic (H1N1) 2009 virus, Victoria, Australia. Emerg

Jessica Kovalchick, RPA-C, is a physician assistant specialist working in Owego, New York.

Infect Dis. 2011;17(9):1599-1607.

14. Verma S, Dhanak M, Frankenfield J. Visualizing the effectiveness of face masks in obstructing respiratory jets. Phys Fluids. 2020;32(6):061708.

References

15. Kim D, Quinn J, Pinsky B, Shah NH, Brown I. Rates of co-infection between

1. Singer BD. COVID-19 and the next influenza season. Sci Adv. Published

SARS-CoV-2 and other respiratory pathogens. JAMA. 2020;323(20):2085-2086.

online May 29, 2020. doi:10.1126/sciadv.abd0086.

16. World Health Organization. Influenza (season). Ask the expert: influenza

2. Centers for Disease Control and Prevention. Estimated influenza

Q&A. World Health Organization website. https://www.who.int/en/news-

illnesses, medical visits, hospitalizations, and deaths in the United

room/fact-sheets/detail/influenza-(seasonal). Published November 6, 2018.

States—2017-2018 influenza season. Centers for Disease Control and

Accessed August 2, 2020.

Prevention website. https://www.cdc.gov/flu/about/burden/2017-2018.htm.

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3. Centers for Disease Control and Prevention. Disease burden of

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influenza. Centers for Disease Control and Prevention website. https://www.

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cdc.gov/flu/about/burden/index.html. Updated April 17, 2020. Accessed

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August 2, 2020.

Published 2020. Accessed August 2, 2020.

4. Jones N. How coronavirus lockdowns stopped the flu in its tracks. Nature

19. Lauer SA, Grantz KH, Bi Q, et al. The incubation period of coronavirus

website. https://www.nature.com/articles/d41586-020-01538-8. Published

disease 2019 (COVID-19) from publicly reported confirmed cases:

May 21 2020. Accessed August 2, 2020.

estimation and application. Ann Int Med. 2020;172(9):577-582.

5. World Health Organization. Global influenza strategy 2019-2030. World

20. Tang X, Rong-Hui D, Wang R, et al. Comparison of hospitalized patients

Health Organization website. https://apps.who.int/iris/bitstream/hand

with ARDS caused by COVID-19 and H1N1. Chest. 2020;158(1):195-205.

le/10665/311184/9789241515320-eng.pdf?sequence=18&isAllowed=y.

21. Shen, C, Tan M, Song X, et al. Comparative analysis of early-stage clinical

Published 2019. Accessed August 2, 2020.

features between COVID-19 and influenza A H1N1 virus pneumonia. Front

6. Qualls N, Levitt A, Kanade N, et al. Community mitigation guidelines to

Public Health. 2020;8:206.

prevent pandemic influenza - United States, 2017. MMWR Recomm Rep.

22. Ma S, Lai X, Chen Z, Tu S, Qin K. Clinical characteristics of critically ill

2017;66(1):1-34.

patients co-infected with SARS-CoV-2 and the influenza virus in Wuhan,

7. Fong MW, Gao H, Wong JY, et al. Nonpharmaceutical measures for

China. Int J Infect Dis. 2020;96:683-687.

pandemic influenza in nonhealthcare settings - social distancing measures.

23. Centers for Disease Control and Prevention. Influenza (flu). Influenza

Emerg Infect Dis. 2020;26(5):976-984.

antiviral medications. https://www.cdc.gov/flu/professionals/antivirals/index.

8. Centers for Disease Control and Prevention. Influenza (flu). Preventive

htm. Centers for Disease Control and Prevention website. Updated

steps. Centers for Disease Control and Prevention website. https://www.cdc.

July 13, 2020. Accessed August 2, 2020.

gov/flu/prevent/prevention.htm. Updated October 9, 2019. Accessed August

24. Uyeki TM, Bernstein HH, Bradley JS, et al. Clinical practice guidelines

2, 2020.

by the Infectious Diseases Society of America: 2018 update on diagnosis,

9. Centers for Disease Control and Prevention. Influenza (flu). Flu

treatment, chemoprophylaxis, and institutional outbreak management of

vaccination coverage, United States, 2018-2019 influenza season. Centers

seasonal influenza. Clin Infect Dis. 2019;68(6):e1-e47.

28 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

FEATURE: LOUISE LEE, EdD, MHA, PA-C; CORINNE ALOIS, MS, PA-C

Spotlight on Fibromyalgia: Updates on Diagnosis and Clinical Management Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, sleep disturbance, and fatigue.

© GETTY IMAGES / MONTAGE BY VIVIAN CHANG

F

ibromyalgia is a complex chronic pain disorder that affects 2% to 4% of the population.1 Patients with fibromyalgia may present with chronic, widespread pain and stiffness, as well as a range of fluctuating associated symptoms.1,2 Patients may experience neurologic (tingling, dizziness, headache and migraine, brain ‘fog’), constitutional (sleep disturbance, weight change, fatigue), musculoskeletal (pain, stiffness, weakness), gastrointestinal (irritable bowel syndrome, nausea), and psychological (irritability, depression, anxiety) symptoms.1,2 However, fibromyalgia is not a diagnosis of exclusion and relies on thorough history-taking and physical examination. The diagnostic process can be challenging and frustrating to patients and clinicians. Once a patient is diagnosed, management goals include controlling and/or decreasing pain, fatigue, and depression associated with the disease and improving overall function and quality of life. Treatment is individualized to a patient’s needs and includes pharmacologic and nonpharmaceutical options.

Clinical Presentation and Diagnosis

Fibromyalgia is linked to a central pain processing defect.

In 2011, the American College of Rheumatology (ACR) proposed revised diagnostic criteria for fibromyalgia.3 These criteria used 2 widely known pain scales: the Widespread Pain Index (WPI) and the Symptom Severity Score (SSS). The WPI measures pain scores in 19 locations throughout the body using a score range of 0 to 19, and the SSS www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 29

FIBROMYALGIA: CENTRALIZED PAIN DISORDER

assesses fatigue, non-restorative sleep, cognitive symptoms, and a combination of these criteria using a score range of 0 to 12.3 Despite the update, experts remained concerned about the validity of these new diagnostic criteria due to their lack of diagnostic specificity and inability to help clinicians identify a cause of the disease.2,4 As a result, further revisions were made in 2016, when the ACR reintroduced a widespread pain criterion defined by pain in at least 4 of 5 body regions (not including jaw, chest, or abdomen).4 The current ACR diagnostic criteria require the presence of widespread pain for a minimum of 3 months and either a WPI score of ≥7 and an SSS score of ≥5 or a WPI of 4 to 6 and SSS score of ≥9.4 According to the authors,“This revision combines physician and questionnaire criteria, minimizes misclassification of regional pain disorders, and eliminates the previously confusing recommendation regarding diagnostic exclusions.”4 Palpation of trigger points, a component of the 1990 ACR guidelines, is optional for diagnosis under the current guidelines, but the presence of tenderness on palpation likely would help validate the diagnosis.5 Further diagnostic testing may be beneficial to rule out other comorbid conditions, such as rheumatoid arthritis, but the absence of findings related to comorbid diseases does not exclude a diagnosis of fibromyalgia because there are no specific diagnostic tests for the condition.6 Blood tests, including the FDA-compliant FM/a Test (EpicGenetics) and IsolateFibromyalgia test (IQuity), show promise for diagnosing fibromyalgia, but more supporting evidence is needed before these tests can be considered part of the work-up.

Other suggested diagnostic evaluations include complete blood count, basic metabolic panel, liver function tests, measurement of C-reactive protein levels or erythrocyte sedimentation rate, and thyroid function tests. Autoimmune screening tests should be performed only if there is a strong clinical suspicion of an inflammatory autoimmune condition.5

TABLE. FDA-Approved Drugs for Treatment of Fibromyalgia

Management Framework for FM

Approved Treatments For most patients with fibromyalgia, pharmacologic management aims to reduce symptoms such as pain and improve quality-of-life. The FDA has approved 3 medications for the treatment of fibromyalgia: pregabalin, duloxetine, and milnacipran (Table).12 Pregabalin, approved by the FDA for the treatment of fibromyalgia in 2007, is an anticonvulsant and analgesic that works by binding to the α-2-Δ subunit of voltage-gated calcium channels in the central nervous system.11 The usual starting dose is 75 mg twice daily, titrated up to 225 mg twice daily.

Patients taking pregabalin should have complete metabolic panels checked regularly to monitor creatinine clearance.11

There is no cure for fibromyalgia; therefore, the treatment goals are to manage the pain, fatigue, and depression associated with the condition and improve patient function. Clinicians should educate patients about their chronic condition, considering an individualized management plan to address each patient’s symptoms.

Although there is no clear pathophysiologic mechanism for fibromyalgia, evidence suggests that patients have an abnormality in central pain processing.5,7,8 Centralized pain, also referred to as central pain, central sensitization, or nociplastic pain, includes any chronic pain disorder with no identifiable mechanism of action outside the central nervous system.

The International Association for the Study of Pain (IASP)

Drug

Drug Class

Starting Dose

Target Dose

Pregabalin

Antiepileptic

75 mg BID

225 mg BID

Duloxetine

SNRI

30 mg/d

60 mg/d

Milnacipran

SNRI

12.5 mg/d

50 mg/BID

BID, twice a day; SNRI, serotonin and norepinephrine reuptake inhibitor

has defined nociplastic pain as “pain that arises from altered nociception despite no clear evidence of actual or threatened tissue damage causing the activation of peripheral nociceptors or evidence for disease or lesion of the somatosensory system causing the pain.”9 Management of fibromyalgia pain is different from that of other pain conditions, such as many types of arthritis, and both nonpharmacologic and pharmacologic options should be considered. All patients with fibromyalgia are encouraged to engage in regular cardiovascular exercise and stress reduction interventions and have good sleep hygiene. Patients also may benefit from cognitive-behavioral therapy (CBT), biofeedback, relaxation therapy, or other forms of counseling.10,11 Complementary medicine approaches, such as acupuncture and correction of nutritional deficiencies, are growing in popularity, despite a lack of good evidence supporting their efficacy.

Although nonpharmacologic interventions are the first line of treatment and can be efficacious, patient non-compliance, especially with respect to physical activity, can limit their success.

Evidence guidelines recommend at least 2 nonpharmacologic therapies (eg, CBT and exercise) combined with pharmacologic treatments for the management of fibromyalgia.11

30 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

Continues on page 34

FIBROMYALGIA: CENTRALIZED PAIN DISORDER

Duloxetine and milnacipran, approved in 2008 and 2009, respectively, are serotonin and norepinephrine reuptake inhibitor agents.11 These drugs alter levels and function of neurotransmitters and address the anxiety and depression that often affect patients with fibromyalgia.5 The usual starting dose of duloxetine is 30 mg once daily, titrated to 60 mg after 1 week. Milnacipran usually is started at 12.5 mg daily and titrated to 50 mg twice daily.12

References 1. American College of Rheumatology. Fibromyalgia. https://www. rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/ Fibromyalgia. Accessed August 3, 2020.

2. Stewart JA, Mailler-Burch S, Muller D, et al. Rethinking the criteria for fibromyalgia in 2019: the ABC indicators. J Pain Res. 2019;12:2115-2124.

3. Wolfe F, Clauw DJ, Fitzcharles MA, et al. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification

Off-Label Treatments Although not approved by the FDA for this indication, the tricyclic antidepressant amitriptyline is the most common off-label medication prescribed to treat fibromyalgia. Patients generally are prescribed 25 to 50 mg of amitriptyline daily and report an improvement in pain, sleep disturbance, and fatigue.

Reported adverse reactions include dry mouth, somnolence, gastrointestinal disturbances, and weight gain, which may limit the drug’s rate of titration.11 Cyclobenzaprine is a muscle relaxant that also is used for the management of fibromyalgia symptoms including pain and sleep disturbances. However, many patients report adverse effects, including drowsiness, dry mouth, fatigue, dizziness, nausea, and heartburn.11,12 Tramadol, a synthetic opioid receptor agonist, is considered by some to be an alternative option that offers additional analgesic effects through enhanced serotonin release and inhibition of norepinephrine reuptake.5,11 Despite some evidence showing their efficacy, nonsteroidal anti-inflammatory drugs seldom are used in combination with antidepressants or anticonvulsants because they may suppress the antidepressant action of these agents.11 When deciding on which agents to prescribe to treat fibromyalgia, clinicians should consider patient preferences, risk factors, and comorbidities. If medications are prescribed, they should be started at low doses and prudently titrated as needed. Patients who do not report an improvement in their fibromyalgia symptoms or are unable to tolerate adverse effects are advised to discontinue these medications and consider alternative therapies.5,10-12

of the ACR preliminary diagnostic criteria for fibromyalgia. J Rheumatol.

2011;38(6):1113-1122.

4. Wolfe F, Clauw DJ, Fitzcharles MA, et al. 2016 revisions to the 2010/2011 fibromyalgia diagnostic criteria. Seminar Arthritis Rheum. 2016; 46(3):319-329.

5. Rahman A, Underwood M, Carnes D. Fibromyalgia. BMJ. 2014;348:g2870.

6. Weir P, Halan GA, Nkoy FL, et al. The incidence of fibromyalgia and its associated comorbidities: a population-based retrospective cohort study based on International Classification of Diseases, 9th Revision codes. J Clin Rheumatol. 2006;12(3):124-128.

7. Abeles A, Pillinger MH, Solitar BM, Abeles M. Narrative review: the pathophysiology of fibromyalgia. Ann Intern Med. 2007;146(10):726-734.

8. Price DD, Staud R. Neurobiology of fibromyalgia syndrome. J Rheumatol Suppl. 2005;75: 22-28.

9. International Association for the Study of Pain (IASP). IASP Council adopts task force recommendation for third mechanistic descriptor of pain. November 14, 2017. https://www.iasp-pain.org/PublicationsNews/ NewsDetail.aspx?ItemNumber=6862. Accessed August 3, 2020.

10. Kwiatek R. Treatment of fibromyalgia. Aust Prescr. 2017;40(5):179-183.

11. Thomas SA, Knight L, Balian A. Treatment of fibromyalgia pain. US Pharm.

2016;41(3):51-54.

12. Arnold LM, Clauw DJ, Dunegan LJ, Turk, DC, FibroCollaborative.

A framework for fibromyalgia management for primary care providers.

Mayo Clin Proc. 2012;87(5):488-496.

Summary

Do you have a

Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and functional impairment.To optimize care of this complex condition, health care practitioners should work with patients to develop individualized management plans tailored to their symptoms. ■

Clinical Pearl

Louise Lee, EdD, MHA, PA-C, has been a practicing physician assistant since 1987. For the past 16 years, Dr Lee has been a fulltime educator and is Program Director at St. John’s University Queens Campus; Corinne Alois, MS, PA-C, is an assistant professor at St. John’s University Queens Campus, New York.

Please submit your pearl to: editor@ClinicalAdvisor.com

34 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

that you would like to share with your colleagues?

FEATURE: SALARY SURVEY

Are you being fairly compensated? primary care (5.54%); for PAs, urgent care came in second (6.34%).

The majority of NP and PA respondents reported working in the South (33% and 23.7%, respectively), and providers in this area reported making an average salary of $108,336 and $114,696. Similar to the findings from the 2019 survey, both NPs and PAs in the West reported making the highest average salaries ($127,195 and $121,185). The majority of NPs responded working in urban areas (37.4%), with suburban areas closely following (31.7%). For PAs, the majority of respondents reported working in suburban areas (34.2%) with urban following closely behind (30.1%).

We asked our readers how the COVID-19 pandemic has affected their practice. Many clinicians reported being furloughed, receiving pay cuts, or having to furlough employees. When we asked our readers if the pandemic has impacted their income, 51.8% of NPs and 58.3% of PAs did not experience reduced salaries. However, for those respondents who did experience reductions in salaries, the majority were NPs (29.9%) compared with PAs (13.3%).

Similar percentages of both NP and PA respondents reported feeling “satisfied” with their compensation (35.3% of NPs and 34.4% of PAs). However, the respondents who reported feeling “very satisfied” earned the highest average salary ($131,263 for NPs and $132,629 for PAs). The majority of both NPs and PAs expect to earn the same salary in 2021 (41.2% and 35.2%, respectively), while 31.8% of NPs and 30.1% of PAs expected to earn a higher salary in 2021.

36 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

© GETTY IMAGES / MONTAGE BY VIVIAN CHANG

See how your salary compares with those of your peers as reported in the 2020 NP/PA SALARY SURVEY

Throughout its 22 year history, the Clinical Advisor has strived to highlight the successes and accomplishments of the nurse practitioner (NP) and physician assistant (PA) fields.

The COVID-19 pandemic has arguably made this year the most challenging for clinicians, with some practices shuttered, employees furloughed, and many health care workers on the move.

However, 2020 has also brought advancements in clinical practice, prescribing legislation, and virtual wellness. As these areas of practice have evolved, so too has compensation. For clinicians considering a career in a new location, specialty, or practice area but may be unsure how this change may impact compensation, especially during the COVID-19 pandemic, the results of the 2020 NP/PA Salary Survey may help navigate these areas of uncertainty.

Similar to the results from previous years, the results from 2020 found that the majority of NPs and PAs who responded to the survey reported earning a higher salary this year compared with last year (40.5% and 32.3%, respectively). However, similar numbers of respondents for both groups reported earning the same salary as last year (34% of NPs and 28.6% of PAs).

Last year, approximately 27% of NPs and 13.8% of PAs reported working in family medicine. For the 2020 survey, 23.67% of NPs and 11.86% of PAs reported working in this area of practice. NPs working in family medicine made an average salary of $104,928, and PAs working in this area of practice made an average salary of $112,961.

For NPs, the next most common area of practice was

See the complete survey results online at ClinicalAdvisor.com/SalarySurvey2020

TABLE 1. Average NP salary by profession

TABLE 2. Average PA salary by profession

Profession

Percent

Average salary

Average hourly rate

Profession

Percent

Average salary

Average hourly rate

Nurse Practitioner

100.0% (n=1,373)

$112,985

$64.00

Physician Assistant

100.0% (n=489)

$116,080

$50.67

TABLE 3. Average NP salary by practice area

TABLE 4. Average PA salary by practice area

Practice area

Percent

Average salary

Practice area

Percent

Average salary

Family Medicine

23.67% (n=325)

$104,928

Family Medicine

11.86% (n=58)

$112,961

Primary Care

5.54% (n=76)

$106,368

Urgent care

6.34% (n=31)

$112,885

Pediatrics

4.95% (n=68)

$100,154

Emergency Medicine

4.91% (n=24)

$128,001

Psychiatry

4.95% (n=68)

$138,445

Orthopedic surgery

3.68% (n=18)

$118,612

Geriatric Medicine

4.59% (n=63)

$115,273

Primary care

3.68% (n=18)

$109,376

Adult Medicine

4.37% (n=60)

$116,631

Obstetrics/ Gynecology

2.86% (n=14)

$101,251

3.20% (n=44)

$108,107

General internal medicine General surgery

2.66% (n=13)

$122,046

Cardiology

3.13% (n=43)

$113,251

Pediatrics

2.66% (n=13)

$120,358

Urgent Care

3.13% (n=43)

$120,139

Acute Care

2.69% (n=37)

$118,959

Oncology/ hematology

2.25% (n=11)

$111,750

Other

39.77% (n=546)

$117,260

Other

59.1% (n=289)

$117,239

TABLE 5. Average NP salary by degree obtained

TABLE 6. Average PA salary by degree obtained

Degree

Percent

Average salary

Degree

Percent

Average salary

Masters

72.8% (n=999)

$111,255

Masters

49.9% (n=244)

$111,498

Doctorate

15.3% (n=210)

$120,661

$119,917

1.4% (n=19)

$119,584

Certificate of completion

16.4% (n=80)

Post Masters Other

1.5% (n=21)

$111,608

Doctorate

11.0% (n=54)

$133,682

TABLE 7. Average NP salary according to gender

TABLE 8. Average PA salary according to gender

Female

Male

Female

Male

$110,720 (n=1,119)

$132,320 (n=129)

$114,657 (n=242)

$119,177 (n=135)

FIGURE 1. Do you work at multiple locations (NPs)?

35.3% (n=485)

55.6% (n=764)

FIGURE 2. Do you work at multiple locations (PAs)?

Yes No

31.9% (n=156)

45.4% (n=222)

Yes No

www.ClinicalAdvisor.com â&#x20AC;˘ THE CLINICAL ADVISOR â&#x20AC;˘ SEPTEMBER 2020 37

FEATURE: SALARY SURVEY

FIGURE 3. Average NP salary by geographic region West (n= 237) $127,195.09 average salary

Midwest (n=298) $107,851.17 average salary

Northeast (n=261) $114,562.37 average salary

FIGURE 4. Average PA salary by geographic region West (n= 87) $121,184.66 average salary

Midwest (n=66) $109,530.49 average salary

Northeast (n=109) $117,932.58 average salary

South (n=453) $108,336.31 average salary

FIGURE 5. Did you earn more this year (NPs)?

South (n=116) $114,695.62 average salary

FIGURE 6. Did you earn more this year (PAs)?

12.7%

13.3%

(n=62)

(n=182)

More

More

40.5%

32.3%

Same

(n=556)

34.0%

28.6%

Less

(n=467)

FIGURE 7. Do you expect to earn more next year (NPs)?

(n=158)

Same Less

(n=140)

FIGURE 8. Do you expect to earn more next year (PAs)?

14.9%

8.4%

(n=204)

(n=41)

More

31.8%

30.1%

Same

(n=436)

41.2%

(n=147)

35.2%

Less

TABLE 9. Average NP salary by experience level

Same Less

(n=172)

(n=565)

More

TABLE 10. Average PA salary by experience level

Experience in years

Percent

Average salary

Experience in years

Percent

Average salary

<5

34.7% (n=476)

$104,440

<5

19.4% (n=95)

$107,906

6-10

18.5% (n=254)

$116,617

6-10

11.5% (n=56)

$104,931

11-15

10.3% (n=141)

$113,763

11-15

8.6% (n=42)

$111,417

16-20

9.0% (n=124)

$120,553

16-20

10.8% (n=53)

$123,663

>20

18.5% (n=254)

$122,736

>20

27.0% (n=132)

$125,506

38 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

See the complete survey results online at ClinicalAdvisor.com/SalarySurvey2020

TABLE 11. Average NP salary according to practice setting

TABLE 12. Average PA salary according to practice setting

Practice setting

Percent

Average salary

Practice setting

Percent

Average salary

Clinic: Stand-Alone

19.4% (n=267)

$106,784

Clinic: Stand-Alone

18.4% (n=90)

$111,950

Clinic: Hospital

18.7% (n=257)

$115,401

Clinic: Hospital

18.4% (n=90)

$116,567

Office Practice

13.3% (n=183)

$108,725

Hospital

13.3% (n=65)

$126,223

Hospital

10.9% (n=150)

$122,224

Office Practice

10.8% (n=53)

$111,342

Walk-in/ Ambulatory Care

3.9% (n=53)

$117,408

Walk-in/ Ambulatory Care

4.5% (n=22)

$105,001

Long-term Care

2.8% (n=39)

$113,791

Education/Academic

1.2% (n=6)

$105,000

Education/Academic

2.3% (n=32)

$106,161

Military/VA

1.2% (n=6)

$117,501

School/University

2.3% (n=31)

$97,501

Solo Practice

1.0% (n=5)

$112,501

Home Health

2.1% (n=29)

$110,596

School/Uniiversity

0.8% (n=4)

$120,001

Military/VA

1.7% (n=23)

$133,834

Consultant

0.4% (n=2)

$176,250

TABLE 13. Number of patients seen per week (NPs)

TABLE 14. Number of patients seen per week (PAs)

Patients per week

Percent

Patients per week

Percent

<25

18.4% (n=252)

<25

11.5% (n=56)

26-50

28.1% (n=386)

26-50

22.5% (n=110)

51-75

21.0% (n=288)

51-75

19.6% (n=96)

76-100

15.5% (n=213)

76-100

13.7% (n=67)

101-125

4.7% (n=64)

101-125

5.3% (n=26)

>125

3.4% (n=46)

>125

4.7% (n=23)

TABLE 15. How satisfied are you with your compensation (NPs)?

TABLE 16. How satisfied are you with your compensation (PAs)?

Response

Percent

Average Salary

Response

Percent

Average Salary

Very Satisfied

9.7% (n=133)

$131,263.36

Very Satisfied

8.8% (n=43)

$132,629.50

Satisfied

35.3% (n=485)

$116,206.54

Satisfied

34.4% (n=168)

$120,020.65

Neutral

22.4% (n=307)

$110,339.55

Neutral

16.4% (n=80)

$113,214.76

Dissatisfied

16.7% (n=229)

$100,710.73

Dissatisfied

12.9% (n=63)

$98,944.93

Very Dissatisfied

3.7% (n=51)

$110,197.86

Very Dissatisfied

1.2% (n=6)

$99,167.17

FIGURE 9. Does your employer offer retirement benefits (NPs)?

74.3% (n=1,020)

13.5% (n=185)

Yes No

FIGURE 10. Does your employer offer retirement benefits (PAs)?

62.8% (n=307)

10.8% (n=53)

Yes No

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 39

FEATURE: SALARY SURVEY

TABLE 17. Hours per week worked (NPs)

TABLE 18. Hours per week worked (PAs)

Hours per week

Percent

Hours per week

Percent

<20

4.4% (n=60)

<20

2.9% (n=14)

21-30

7.3% (n=100)

21-30

5.1% (n=25)

31-40

42.6% (n=585)

31-40

36.8% (n=180)

41-50

30.1% (n=413)

41-50

26.0% (n=127)

51-60

4.6% (n=63)

51-60

4.5% (n=22)

61-70

0.7% (n=10)

61-70

1.2% (n=6)

>70

1.3% (n=18)

>70

0.8% (n=4)

TABLE 19. Average NP salary by urban, suburban, or rural location

TABLE 20. Average PA salary by urban, suburban, or rural location

Location

Percent

Average salary

Location

Percent

Average salary

Suburban

31.7% (n=435)

$110,893

Suburban

34.2% (n=167)

$119,013

Urban

37.4% (n=514)

$114,455

Urban

30.1% (n=147)

$113,739

Rural

21.8% (n=300)

$113,359

Rural

13.1% (n=64)

$113,721

TABLE 21. Has the COVID-19 pandemic affected your income (NPs)?

TABLE 22. Has the COVID-19 pandemic affected your income (PAs)?

Response

Percent

Response

Percent

Yes, Income Increased

6.0% (n=83)

Yes, Income Increased

4.1% (n=20)

Yes, Income Decreased

29.9% (n=410)

Yes, Income Decreased

13.3% (n=65)

No

51.8% (n=711)

No

58.3% (n=285)

FIGURE 11. Do you receive reimbursements for CME (NPs)?

62.9% (n=864)

37.1% (n=509)

Yes No

FIGURE 13. Do you receive reimbursements for Tuition (NPs)?

24.3% (n=334)

75.7% (n=1,039)

Yes No

FIGURE 15. Do you receive reimbursements for Licensure Fees (NPs)?

53.6% (n=736)

46.4% (n=637)

Yes No

FIGURE 12. Do you receive reimbursements for CME (PAs)?

60.7% (n=297)

39.3% (n=192)

Yes No

FIGURE 14. Do you receive reimbursements for Tuition (PAs)?

17.6% (n=86)

82.4% (n=403)

Yes No

FIGURE 16. Do you receive reimbursements for Licensure Fees (PAs)?

50.7% (n=248)

40 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

49.3% (n=241)

Yes No

Dermatology Clinic CASE #1

Hyperpigmented Patch With Hair Growth on Chest RACHEL GRAUBARD, BS; EMILY BURNS, BA; CHRISTOPHER RIZK, MD

A 12-year-old boy presents to the dermatology clinic with a 2-year history of a brown patch on his chest. The 8-cm patch had been asymptomatic, but over the past 6 months, it has become darker, with hair and acne vulgaris developing within the lesion.The patient is self-conscious about the lesion’s appearance and wishes to learn if it can be treated to lessen the hyperpigmentation.

What is your diagnosis? Turn to page 42

CASE #2

Growing Blood Vessels on the Tongue and Lips KELLY MCCOY, BS, MA; JULIA R. NUNLEY, MD

A 45-year-old woman presents with enlarging blood vessels on her tongue that recently have increased in size and number. Numerous 1- to 2-mm discrete red macules and papules are seen on her tongue, oral mucosa, nose, lower lip, and fingertips. She has had frequent nosebleeds since childhood as well as iron-deficiency anemia that has not responded to iron supplementation. Her father, who died at the age of 50, had similar symptoms.

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Dermatology Clinic CASE #1

Becker Nevus

Becker nevus is an acquired patch or thin plaque of hyperpigmentation and excessive hair growth that was first described in 1949 by William Becker.1 These benign, hamartomatous lesions commonly occur in a unilateral distribution across the upper trunk, shoulders, and back. They are asymmetrical, with sharply demarcated borders. Classically, patients report the appearance of increasing brown pigmentation, followed by progressive hair growth over several years.1 Becker nevi typically develop or become more pronounced in peripubertal adolescents when androgen levels rise and lead to increased genital skin pigmentation, hair growth, and muscle hypertrophy.2 The lesions may first appear in early adulthood, but this is less common.These nevi are believed to be the result of increased androgen sensitivity and upregulation of androgen receptors within the lesions, which cause varying degrees of localized melanosis, smooth muscle hyperplasia, and hair thickening.3 Due to the androgen-dependent nature of their pathogenesis, Becker nevi are identified more frequently in men.The diagnosis may be missed in women whose lesions are lighter in color or have less hair growth because of comparatively lower androgen levels.4 These nevi may occur as isolated lesions or as part of a constellation of other developmental anomalies of the breast or skeleton, known as Becker nevus syndrome.5 The syndrome arises sporadically, following a somatic mutation during embryogenesis that results in subsequent mosaicism with loss of heterozygosity. Although the presentation of Becker nevus syndrome occurs on a spectrum, the most common clinical manifestations that accompany the nevi are hypoplasia of the breast or limb ipsilateral to the lesion6 or vertebral defects, such as scoliosis or spina bifida occulta.5 Becker nevi occasionally are diagnosed based on their clinical appearance and patient history.2 Patients describe sudden-onset or worsening dark pigmentation of the lesion, with subsequent development of androgen-dependent changes within the lesion, such as thick hair growth or acne vulgaris. A biopsy and microscopic examination are performed to make a definitive diagnosis and to differentiate Becker nevi from other pigmented lesions.1,2 On histologic examination, Becker nevi display many features of nevoid lesions, including acanthosis with bridging of elongated rete ridges and increased basal melanin. However, unlike true nevi, Becker nevi lack nevomelanocytic structures.1,5

Histologic examination reveals smooth muscle proliferation rather than nests of melanocytes.

Identification of a Becker nevus should prompt further evaluation for other developmental malformations including a thorough physical examination and radiographic imaging of the spine to rule out Becker nevus syndrome.7 The differential diagnosis includes other pigmented lesions commonly seen in adolescence, such as café-au-lait macules, congenital smooth muscle hamartomas, and congenital melanocytic nevi. Ordinarily, these congenital lesions are present at birth, whereas Becker nevi develop after the first decade of life.8,9 When the diagnosis is unclear based on clinical history and appearance, a biopsy should be performed to make a definitive diagnosis and determine the correct management.9 Clinically, congenital smooth muscle hamartomas may present similarly to Becker nevi — as hyperpigmented lesions with increased hair growth. A distinctive finding of congenital smooth muscle hamartomas is the pseudo-Darier sign, in which the lesion becomes increasingly elevated or indurated in response to tactile stimulation.8 Histologically, both lesions demonstrate dermal smooth muscle hyperplasia, but this finding is more pronounced in congenital smooth muscle hamartomas; Becker nevi exhibit greater pigmentation in the basal layer.9 The clinical course of these lesions also differs.The hyperpigmentation and hypertrichosis associated with congenital smooth muscle hamartomas decreases over time but increases in Becker nevi. Congenital smooth muscle hamartomas frequently are observed in the lumbosacral area as opposed to the upper trunk with Becker nevi.9 Congenital melanocytic nevi can be differentiated from Becker nevi on microscopic examination by the presence of melanocytes with nevoid features.9 Due to the absence of melanocytic variants in Becker nevi, malignant transformation is unlikely to occur. Therefore, isolated, asymptomatic lesions can be managed conservatively, and surgical excision is not indicated.4 However, patients often request treatment for cosmetic purposes.

Hyperpigmentation traditionally is addressed with either ablative or Q-switched laser treatment. Laser therapy is time consuming, often requiring several treatment sessions. Ablative lasers are used to completely remove the epidermis, eradicating the lesion with residual scarring. Q-switched lasers target intralesional pigment within the dermis and epidermis. However, because the epidermis is not removed, complete removal of the lesion rarely is accomplished. Fractional resurfacing has been shown to be clinically effective and less invasive.10 After evaluating the patient in this case for associated bony and soft tissue abnormalities, we discussed treatment options.

He and his parents opted to defer treatment.

42 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

Rachel Graubard, BS, and Emily Burns, BA, are students at Baylor College of Medicine, and Christopher Rizk, MD, is a dermatology fellow at Elite Dermatology in Houston,Texas.

References 1. Becker SW. Concurrent melanosis and hypertrichosis in distribution of nevus unius lateris. Arch Derm Syphilol. 1949;60(2):155-160.

2. Tymen R, Forestier JF, Boutet B, Colomb D. [Late Becker’s nevus. One hundred cases (author’s transl)]. Ann Dermatol Venereol. 1981;108(1):41-46.

3. Person JR, Longcope C. Becker’s nevus: an androgen-mediated hyperplasia with increased androgen receptors. J Am Acad Dermatol. 1984;10(2 Pt 1):235-238.

4. Hsu S, Chen JY, Subrt P. Becker’s melanosis in a woman. J Am Acad Dermatol. 2001;45(6 suppl):S195-S196.

5. Happle R, Koopman RJ. Becker nevus syndrome. Am J Med Genet.

1997;68(3):357-361.

6. Glinick SE, Alper JC, Bogaars H, Brown JA. Becker’s melanosis: associated abnormalities. J Am Acad Dermatol. 1983;9(4):509-514.

7. Ghosh SK, Majumder B, Agarwal M. Becker’s nevus syndrome: a report of a rare disease with unusual associations. Int J Dermatol. 2017;56(4):458-460.

8. Schmidt CS, Bentz ML. Congenital smooth muscle hamartoma: the importance of differentiation from melanocytic nevi. J Craniofac Surg. 2005;16(5):926-929.

9. Bilgiç Ö, Tunçez Akyürek F, Altınyazar HC. Pseudo Darier sign: a distinctive finding for congenital smooth muscle hamartoma. J Pediatr. 2016;169:318.

10. Glaich AS, Goldberg LH, Dai T, Kunishige JH, Friedman PM. Fractional resurfacing: a new therapeutic modality for Becker’s nevus. Arch Dermatol.

2007;143(12):1488-1490.

CASE #2

Hereditary Hemorrhagic Telangiectasia

The diagnosis of hereditary hemorrhagic telangiectasia (HHT) syndrome, also known as Osler-Weber-Rendu disease, was made based on the patient’s medical and family history and characteristic clinical findings.

An autosomal dominant disease, HHT is a vascular disorder that manifests with telangiectases of the oral mucosa, lips, nose, and fingertips, as well as arteriovenous malformations (AVMs) affecting multiple organs, including the lungs, brain, and kidneys.1 HHT typically presents with a familial pattern of epistaxis and iron deficiency due to chronic gastrointestinal blood loss in the setting of telangiectasia.2 Henry Sutton, Benjamin Babington, and John Legg were the first to describe this familial syndrome of recurrent nosebleeds

in the late 19th century.3-5 However, the disorder was named for 3 other 19th century physicians,William Osler, Henri Jules Louis Marie Rendu, and Frederick Parkes Weber, after they further characterized the syndrome and reported the association between epistaxis, mucocutaneous lesions, and visceral AVMs.6-8 In 1909, Frederic Hanes was the first to coin the term hereditary hemorrhagic telangiectasia, as the syndrome is called today.9 The current diagnostic criteria for HHT were established by international consensus in 2000.10 They are based on the Curaçao Criteria, which delineate a scoring system evaluating 4 features: spontaneous and recurrent epistaxis; multiple telangiectases at characteristic sites (lips, oral cavity, nose, and fingers); visceral involvement (eg, gastrointestinal telangiectasia; pulmonary, cerebral, or hepatic AVMs); and a first-degree relative with either the same clinical criteria or in whom HHT has been diagnosed genetically.3 If at least 3 of these criteria are present, a definite diagnosis of HHT can be made; if 2 criteria are present, a probable diagnosis can be considered; and if 1 or no criterion is present, a diagnosis of HHT is unlikely. Genetic testing is available to confirm the diagnosis but usually is not necessary.10 Mucocutaneous telangiectases are visible in about 75% to 90% of those with HHT.11 These appear as thin spider weblike red macules and papules with dilated superficial blood vessels (capillaries, venules, or arterioles) that blanch with pressure.11 Rare at birth, telangiectases normally develop by the third decade of life and increase in size and number with age.11 When telangiectases are present in the pediatric population, they often are found in places other than those listed as characteristic sites in the Curaçao criteria.12 Most clinical manifestations of HHT are due to mucocutaneous telangiectases. Their presence in the nose results in spontaneous and recurrent epistaxis, the most common presentation of HHT.11 Epistaxis tends to occur early in life, even before telangiectases become apparent.11 Telangiectases and small AVMs subsequently develop throughout the gastrointestinal tract, especially the stomach and duodenum; this can result in hemorrhage, most commonly in the fourth and fifth decades of life.11 Although 75% of patients have gastric or small intestinal telangiectases, only 33% have gastrointestinal bleeding.11 HHT occurs in approximately 1 in 5,000 to 8,000 live births.1 Although HHT is inherited in an autosomal dominant fashion, disease penetrance and expression vary greatly.These variations likely contribute to the low number of reported cases worldwide, since many cases are undiagnosed.1 Mutations causing HHT were detected as early as 1994.13 A total of 85% to 90% of cases studied have a mutation in either endoglin (ENG) or activin A receptor type II-like1 (ACVRL1) — genes within a signaling pathway that regulates cell proliferation, differentiation, apoptosis, and migration.13

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 43

Dermatology Clinic Mutations in SMAD4, which has a role in the same signaling pathway, account for about 10% of patients with HHT.14 Yet, there are a significant number of patients in whom the genetic abnormality has yet to be determined.13,14 HHT is not the only disorder to present with vascular dysplasia. Other conditions to consider in the differential diagnosis include benign and malignant tumors, vascular hemorrhage, and other systemic disorders that present with telangiectases, such as ataxia-telangiectasia, Bloom syndrome, cirrhosis of the liver, and various connective tissues diseases. Distinguishing these from HHT depends on vascular morphology as well various clinical indicators.

The cerebellar ataxia and immune deficiency associated with ataxia-telangiectasia and the anatomic abnormalities of Bloom syndrome allow for differentiation of these syndromes quickly.The classic spider angioma of cirrhosis has a distinct appearance, with a central perforating vessel and a surrounding array of capillaries. In lupus, dermatomyositis, and scleroderma, telangiectases typically affect the nail folds, not the nail beds, and facial and mucosal telangiectasia may be present.

addition, she is working with a genetic counselor to consider genetic testing and screening for her 2 adolescent daughters. ■ Kelly McCoy, BS, MA, is a medical student atVirginia Commonwealth University, and Julia R. Nunley, MD, is a professor of dermatology at Virginia Commonwealth University in Richmond,Virginia.

References 1. Shovlin CL, Buscarini E, Kjeldsen AD, et al. European Reference Network For Rare Vascular Diseases (VASCERN) outcome measures for hereditary haemorrhagic telangiectasia (HHT). Orphanet J Rare Dis. 2018;13(1):136.

2. Fuchizaki U, Miyamori H, Kitagawa S, Kaneko S, Kobayashi K. Hereditary haemorrhagic telangiectasia. Lancet. 2003;362(9394):1490-1494.

3. Sutton HG. Epistaxis as an indication of impaired nutrition and of degeneration of the vascular system. Med Mirror. 1864;1:769-781.

4. Babington BG. Hereditary epistaxis. Lancet. 1865;86(2195):362-363.

5. Legg JW. A case of haemophilia complicated with multiple naevi. Lancet.

1876;108(2781):856-857.

6. Rendu HJ. Épistaxis répétées chez un sujet porteur de petits angiomes cutanés et muqueux. Gaz Hop Paris. 1896;135:1322-1323.

Most clinical manifestations of hereditary hemorrhagic telangiectasia are due to mucocutaneous telangiectases.

7. Osler W. On a family form of recurring epistaxis, associated with multiple telangiectases of the skin and mucous membranes. Bull Johns Hopkins Hosp.

1901;12:333-337.

8. Weber FP. Multiple hereditary developmental angiomata (telangiectases) of the skin and mucous membranes associated with recurring haemorrhages.

Lancet. 1907;170(4377):160-162.

9. Hanes FM. Multiple hereditary telangiectasis causing hemorrhage (heredi-

After a diagnosis of HHT is made, practitioners can review consensus guidelines, such as the International Guidelines for the Diagnosis and Management of HHT, for information about how to screen for silent features of HHT.15 All individuals should be screened for pulmonary AVMs with chest computed tomography (CT); evidence suggests that identifying AVMs early may reduce the risk for stroke and brain abscess in patients older than 16 years of age.16 Iron status and complete blood counts should be assessed and monitored regularly. Screening for cerebral AVMs is controversial and depends on physician and patient preferences. It is important to refer patients to genetic counselors for education about the natural history of this disease and the benefits of screening family members.15 Treatments for HHT are focused on monitoring and ameliorating the signs and symptoms of the disease. However, recent preclinical studies have identified molecular targets directed at the signaling pathways of the disease that may offer future treatment options.14 Our patient was screened with a chest CT that revealed no pulmonary AVMs, and she opted to forego further imaging.

Her blood count and iron stores will be monitored regularly, and gastrointestinal bleeding will be addressed as needed. In

tary hemorrhagic telangiectasia). Bull Johns Hopkins Hosp. 1909;20:63-73.

10. Shovlin CL, Guttmacher AE, Buscarini E, et al. Diagnostic criteria for hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber syndrome).

Am J Med Genet. 2000;91(1):66-67.

11. Garg N, Khunger M, Gupta A, Kumar N. Optimal management of hereditary hemorrhagic telangiectasia. J Blood Med. 2014;5:191-206.

12. Gonzalez CD, Cipriano SD,Topham CA, et al. Localization and age distribution of telangiectases in children and adolescents with hereditary hemorrhagic telangiectasia: a retrospective cohort study. J Am Acad Dermatol. 2019;81(4):950-955.

13. McDonald J, Wooderchak-Donahue W, VanSant WC, et al. Hereditary hemorrhagic telangiectasia: genetics and molecular diagnostics in a new era.

Front Genet. 2015;6:1 14. Robert F, Desroches-Castan A, Bailly S, Dupuis-Girod S, Feige JJ. Future treatments for hereditary hemorrhagic telangiectasia. Orphanet J Rare Dis. 2020;15(1):4.

15. Faughnan ME, Palda VA, Garcia-Tsao G, et al. International guidelines for the diagnosis and management of hereditary haemorrhagic telangiectasia.

J Med Genet. 2011;48(2):73-87.

16. Shovlin CL, Jackson JE, Bamford KB, et al. Primary determinants of ischaemic stroke/brain abscess risks are independent of severity of pulmonary arteriovenous malformations in hereditary haemorrhagic telangiectasia.

Thorax. 2008;63(3):259-266.

44 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

Dermatologic Look-Alikes Nodules on Hands and Feet CLAIRE J.WIGGINS, BS; ELEANOR JOHNSON, BA; CHRISTOPHER RIZK, MD

CASE #1

CASE #2

A 35-year-old man with a history of osteoarthritis, hyperlipidemia, and gout presents to the dermatology clinic with complaints of a “white bump” on his right first toe near the nail fold. The nodule is not painful or pruritic, although clear discharge has been seen.The patient reports that he has not had any similar lesions. He has no significant dermatologic history and has not had any change in his medications or trauma to the toe. He reports that he noticed the lesion 3 weeks ago and became concerned because it did not go away.

A 32-year-old man with a history of eczema presents to the dermatology clinic with a cluster of “hard, rough bumps” on his right index finger. On physical examination, the lesion appears hyperkeratotic and whitish-yellow with multiple black dots.The patient reports that the nodule is not painful but becomes slightly tender if scratched. Other than eczema, the patient has no significant dermatologic history, and he reports no change in his medications or trauma to the finger.The patient notes that 2 of his friends have similar lesions.

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 45

Dermatologic Look-Alikes CASE #1

Digital Mucous Cyst

Digital mucous cysts (DMCs) are relatively common benign cysts of the digits, occasionally involving the nail matrix and nail fold. First described as “synovial lesions of the skin” by Markin and Jones in 1880 and

by Hyde in 1883,1-3 these cysts are known by various names, including mucoid cyst, mucous cyst of the finger, mucinous pseudocyst, myxomatous cutaneous cyst, and periarticular fibroma, among others.1-3 DMCs are one of the most common growths of the ungual region, second only to verruca vulgaris.1 The condition most frequently affects adults aged 40 to 70 years.1,3 Women are twice as likely as men to suffer from DMCs; there is no known proclivity for any race.1,3 Fingers are more common sites for DMCs than toes, but toes are more likely to be refractory to treatment.1-3 DMCs most commonly develop on an individual’s dominant hand, with the middle finger being most common site, followed by the index finger.1,3 The etiology of DMCs remains unknown. Patients with degenerative joint diseases such as osteoarthritis are at increased risk for DMCs.1 It is thought that some DMCs may arise from arthritic spurs, but direct causation between osteophytes and DMCs has not been well established.1-3 Trauma, especially in younger patients, or repetitive stress due to occupational activities also have been theorized to be inciting factors.1 Histologic categories have been devised based on proposed pathogenesis.1,2,4 The myxomatous, or superficial, subtype is often located near the nail fold and is caused by overactivity of fibroblasts leading to excessive mucin and hyaluronic acid production.The ganglion, or deep, subtype forms from a herniated tendon or joint lining, allowing contents to leak.This type typically is seen in patients with degenerative joint disease.1,2,4 These 2 subtypes often cannot be distinguished clinically.1 DMCs, which are pseudocysts because they are lined by connective tissue rather than epithelial cells, appear histologically as a localized myxoid or collagenous mass, with intermixed fibroblasts, clefts filled with mucin, and, occasionally, an inflammatory infiltrate.1,3 On hematoxylin and eosin stain, the mucinous material appears basophilic.Alcian blue and colloidal iron stains are positive for acid mucopolysaccharides.1,4 Clinically, DMCs present between the distal interphalangeal (DIP) joint and the cuticle on the dorsal or lateral face of the digit or adjacent to the proximal nail fold.The lesions measure <1 cm in diameter, are oval or circular, and appear as translucent,

shiny, smooth, singular nodules.They can fluctuate in volume, unlike an ungual fibroma.1,5 Typically, these cysts are asymptomatic, but patients may find the mass to be bothersome, leaking jelly-like discharge if compressed, impairing range of motion of the DIP joint, and becoming inflamed or mildly painful.1 The differential diagnosis for DMC includes rheumatoid nodule, epidermoid cyst, acral mucinous fibrokeratoma, fibrous histiocytoma, and Heberden nodes. Careful diagnosis is necessary to rule out other conditions and to pursue appropriate treatment.

The diagnosis of DMCs usually is straightforward, especially with expression of characteristic clear, gelatin-like contents.

However, several clinical and laboratory procedures can confirm the diagnosis of DMCs if the presentation is unusual. DMCs will transilluminate under a penlight, fine-needle aspiration will reveal clear gelatinous material, and ultrasound will reveal an anechoic mass with a defined border. Injection of methylene blue can track the pedicle of a cyst to help confirm the ganglion subtype and plan any potential operation. Additionally, electron microscopy, magnetic resonance imaging, and histopathologic analysis can confirm the diagnosis, if necessary.1

Digital mucous cysts present between the distal interphalangeal joint and the cuticle or adjacent to the proximal nail fold.

If asymptomatic, DMCs may resolve without intervention, but they have a high recurrence rate. Conservative treatment options include firm compression, repetitive needling, steroid injection, cryotherapy, carbon dioxide laser, or removal with infrared coagulation. Surgery also is an option and it has the highest cure rate.1-3,5 Surgical procedures may remove the cyst, joint capsule, skin lying above, and any arthritic spurs lying below. Closure is achieved via primary closure, skin flap, or skin graft. Complications of surgery include nail deformation, tendon injury, pain, and bleeding.The more aggressive the surgery, the less likely there will be a recurrence but the more likely there will be complications, such as digit and nail deformation. Despite the high recurrence rate, prognosis is good.1 Patients should be counseled about all the available treatment options, their efficacy, and their complications because the gold standard for treatment has yet to be defined.3 The patient in this case was given a diagnosis of DMC based on history and physical examination and assured that the lesion was benign. He chose to have the lesion removed in the office that day.The procedure resulted in no complications, and the patient did not experience recurrence of the DMC.

46 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

CASE #2

Verruca Vulgaris

Verruca vulgaris (VV), or the common wart, is a benign growth of the skin or mucous membranes. VV lesions present as firm, hyperkeratotic, raised lesions with a rough or cauliflower-like surface. They generally occur on the skin of the hands and feet, although unusual locations such as the tongue and larynx have been reported.6-9 VV is an ancient condition, reported in the literature since Hippocrates in 400 BC. Although it was once believed that a person could contract VV by touching toads, it is now recognized that human papillomavirus (HPV) is the cause of the common wart.8 The virus infects epithelial basal keratinocytes through breaks in the skin, resulting in plaque or nodule formation.7,9 Spread of HPV can occur either through direct contact (touching an infected person) or indirect contact (touching fomites).7-9 The virus also can spread to secondary sites on an individual by auto-inoculation of the virus via scratching.9 HPV infection can cause a singular growth, multiply to cause numerous lesions, or spontaneously resolve without clinical symptoms.7-9 VV on the extremities is most commonly associated with HPV types 1, 2, 4, 27, 40, and 57. Multiple strains often co-infect an individual and can demonstrate synergistic or antagonistic effects on disease manifestation.9 AlthoughVV can occur at any age, it most commonly occurs in 12- to 16-year-olds, affecting as many as 20% of schoolaged children.7 Most people are affected at some point in their lifetime.10 White individuals are twice as likely to have VV than Black individuals or people of Asian descent.There is no predilection for a particular sex. Skin exposure to moisture and trauma increases an individual’s risk for acquiring a VV. Using public showers or swimming pools and handling raw meat (these are aptly named “Butcher’s warts”) are known activities that carry risk forVV. Systemic disease and malignant transformation into verrucous carcinoma are very rare but more common in immunosuppressed patients.7 Histopathologically, granular layer cells from VV lesions contain keratohyalin vacuoles and raisin-like nuclei; these koilocytic changes are diagnostic of an HPV infection. Other findings include hypergranulosis, tortuous capillaries within the dermal papillae, papillomatosis, acanthosis, and digitated epidermal hyperplasia.7 Clinically,VV does not cause severe pain, but it can become an irritant or lead to psychological stress.9 The lesions can limit

joint range of motion, become tender after traumatic contact, or bleed. Typically, bothersome lesions occur on the plantar surface of the foot; they may become so large or numerous that they limit patients’ activities of daily living.7 Diagnosis typically is made clinically;VV is common and the lesions generally have a homogenous appearance. Characteristic brown or red dots, best visualized via dermatoscope, represent thrombosed dermal papilla capillary loops and are indicative of VV. The differential diagnosis includes molluscum contagiosum, lichen planus, digital mucous cyst, seborrheic keratosis, and keratoacanthoma.

If the lesion cannot be diagnosed by history and physical examination, certain laboratory tests can be used. Identification of viral DNA identification via Southern blot hybridization or polymerase chain reaction can confirm an epidermal HPV infection. These tests are more likely to be positive in newer

The human papillomavirus (HPV) is recognized as the cause of verruca vulgaris, the common wart. rather than older lesions. A biopsy of the lesion also can be obtained to rule out other diagnoses, although typically this is not required.7 A large number of cases of VV resolve without treatment: 23% within 2 months, 65% after 3 months, and 78% after 2 years; thus a reasonable treatment plan may be observation.7,9 There are many treatment options available, and several may be indicated to yield a definitive cure. Filing down theVV with a scalpel blade, known as paring, can be used to allow for better penetration of treatments.10 Cryotherapy can be performed in a provider’s office, typically in several sessions, to freeze the wart.7-10 Injection of a Candida antigen can encourage the immune system to identify and fight off the HPV infection.8,10 At home, patients can use over-the-counter treatments that are applied after soaking and filing the lesion.10 Retinoids, compounded wart treatments containing ingredients such as salicylic acid or 5-fluorouracil, or systemic treatment with oral cimetidine are other potential treatments for VV lesions.7,8,10 Prognosis is good for patients with VV. Patients should be counseled that the lesions almost always are benign, that most resolve without treatment and leave no residual scarring, and that if they chose treatment, many rounds may be required before lesion resolution.7,9 Thus, the decision to pursue treatment, which may lead to monetary cost, pain, scarring, and adverse effects, should be considered carefully.

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 47

Dermatologic Look-Alikes Digital Mucous Cyst1-5

Verruca Vulgaris6-10

Dermatologic Presentation

• Translucent, shiny, smooth, singular, round or oval nodules

• Firm, raised, hyperkeratotic papules with a rough or cauliflower-like surface

Associations

• Adults aged 40 to 70 years • Women • Degenerative joint disease

• Adolescents aged 12 to 16 years • White race • Butchers • Use of public showers or pools • Immunosuppression

Etiology

• Unknown

• Human papillomavirus infection

Characteristic Location

• Between the distal interphalangeal joint and the cuticle on the ­dorsal or lateral face of the digit, or adjacent to the proximal nail fold

• Plantar surfaces of the hands and feet

Histology

• Myxomatous and ganglion subtypes • Pseudocysts; myxoid or collagenous mass with intermixed fibroblasts and clefts filled with mucin

• Granular layer cells with keratohyalin vacuoles and granules and raisin-like nuclei • Hypergranulosis, tortuous capillaries within the dermal papillae, papillomatosis, acanthosis, and digitated epidermal hyperplasia

Diagnosis

• History and physical examination • Fine-needle aspiration, ultrasound, methylene blue injection

• History and physical examination • Viral DNA analysis

Treatment

• Treatment not always indicated • Cryotherapy, carbon dioxide laser, infrared coagulation, surgery

• Treatment not always indicated • Cryotherapy, Candida antigen injection, wart paring, salicylic acid, retinoids, systemic cimetidine

Patient education is essential to prevent future lesions and limit the spread of disease. Butchers should wear gloves at work, swimmers should wear footwear around the pool, and cosmetic tools such as nail files and pumice stones should not be shared.

Our patient was treated with cryotherapy in the office. At his follow up appointment, there was mild improvement and he received a second round of cryotherapy after paring and was instructed to use an over-the-counter treatment as well. At his third follow-up visit, the wart had resolved. ■

3. Jabbour S, Kechichian E, Haber R, Tomb R, Nasr M. Management of digital mucous cysts: a systematic review and treatment algorithm. Int J Dermatol.

2017;56(7):701-708.

4. Elder DE, Johnson BL, Elenitsas R, eds. Lever’s Histopathology of the Skin.

9th ed. Lippincott Williams & Wilkins; 2004;1003-1004.

5. De Berker DA, Lawrence CM. Treatment of myxoid cysts. Dermatol Surg.

2001;27(3):296-299.

6. Topdag M, Erdogan S, Kara A, Derin S. Laryngeal verruca vulgaris. BMJ Case Rep. 2015:bcr2014207773.

7. Al Aboud AM, Nigam PK. Wart (plantar, verruca vulgaris, verrucae).

Claire J. Wiggins, BS, and Eleanor Johnson, BA, are students at Baylor College of Medicine, and Christopher Rizk, MD, is a certified dermatologist at Elite Dermatology in Houston,Texas.

In: StatPearls. StatPearls Publishing; 2020.

8. Bope ET, Kellerman RD. Conn’s Current Therapy 2012. Elsevier Health Sciences; 2011:275.

9. Ural A, Arslan S, Ersoz S, Deger B. Verruca vulgaris of the tongue:

References

a case report with a literature review. Bosn J Basic Med Sci. 2014;14(3):

1. Li K, Barankin B. Digital mucous cysts. J Cutan Med Surg. 2010;14(5):199-206.

136-138.

2. Kim EJ, Huh JW, Park HJ. Digital mucous cyst: a clinical-surgical study.

10. Patient perspectives: Warts (verruca vulgaris) and what to do about

Ann Dermatol. 2017;29(1):69-73.

them. Pediatr Dermatol. 2015;32(6):e322-e323.

48 THE CLINICAL ADVISOR • SEPTEMBER 2020 • www.ClinicalAdvisor.com

LEGAL ADVISOR CASE

© BOB SOULÉ / ILLUSTRATION SOURCE

Confidential, Privileged Information Is an overheard murder confession by a patient admissible in court?

BY ANN W. LATNER, JD

Ms P was a nurse who worked in a mental health hospital for several years and knew most of the patients on her floor by name. The nurse was not involved directly in the patients’ treatment; her responsibilities were largely related to medication management.

One afternoon, Ms P was in the hospital’s library, which was used by the patients during their recreation time. A number of patients were looking for books, using the library’s computers, or sitting on chairs or sofas talking.

Ms P became aware of a conversation between 2 patients, Mr C and another patient. These 2 patients were sitting on chairs in the main area of the library, with people walking by them during the conversation.

Mr C, who had been involuntarily committed to the hospital, was telling the other patient about his life. Specifically, Mr C was talking about how he had been “on the run” in 1991, after killing someone. The conversation continued with Mr C discussing how he had been in a bar before the murder, and then he spoke about disposing of the body afterward.

What a patient tells a doctor in the course of seeking medical treatment is privileged and confidential information that cannot generally be used for other purposes.

Mr C made some other comments and then told the other patient that DNA evidence might still be in his van, although the incident had taken place 25 years ago.

Concerned about what she overheard, Ms P wrote a note in the hospital’s computer system documenting the details of the conversation and alerted Mr C’s treatment team. The treatment team was concerned and told the hospital’s administration.

The hospital’s administration met with their attorney to decide what to do with the information. They decided to reveal Mr C’s statement to the police because it was specific enough that it seemed legitimate. It turned out that the police had been investigating the murder for over 20 years, without being able to solve it. When this information was added to what they had, they were able to arrest Mr C for the murder.

Cases presented are based on actual occurrences.

Names of participants and details have been changed.

Cases are informational only; no specific legal advice is intended. Persons pictured are not the actual individuals mentioned in the article.

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 49

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LEGAL ADVISOR Mr C was charged with murder and was represented by a defense attorney who immediately made a motion to exclude from evidence the record of the statement and any testimony regarding the statement that Mr C made in the hospital’s library.

The defense attorney argued that anything Mr C had said was confidential and privileged. The trial court agreed and held that the written notes and any testimony about them should be excluded from Mr C’s trial.

The state (which was prosecuting Mr C) appealed and filed a motion for reconsideration.The state’s attorneys argued that Mr C’s statements were made to a fellow patient, not a psychologist, psychiatrist, or health care worker, and that Ms P had simply overheard them in a public setting. Therefore, argued the state’s attorney, the statement should not be considered privileged.

Despite this argument, the court re-entered its original order, finding that the testimony was privileged.The state appealed to the Superior Court.

Legal Background

On appeal, the Superior Court reversed the trial court’s order and found the incriminating statement to be admissible. The Superior Court noted that Mr C’s argument about why the statement should be inadmissible was that his mental health record and the communications contained therein were privileged under the state’s code pertaining to confidential communications to psychiatrists or psychologists.

However, the court pointed out that Mr C’s disclosures were not made to a psychiatrist or psychologist (or even a health care practitioner of any sort), nor were they made during the

course of treatment. The statements were made to another patient as part of a private conversation during recreation time and outside of any therapy session.

“Put simply,” wrote the Superior Court, “since Mr C did not make his statements to a member of his treatment team, since his statements were not confidential, and since they were not made in the course of treatment, they are not protected under the psychotherapist-client privilege.”

The court held that the statement would be admissible at trial and remanded the case back to the trial court.

Protecting Yourself

The Superior Court looked at this case very narrowly, based on the state code regarding communications to mental health practitioners, since that was what Mr C was using to argue why his statement should not be allowed. However, this was probably a tactical error on Mr C’s part, and he might have been better off with another argument.

In general, courts believe that evidence is extremely important and that exceptions, such as privileged information, must be narrowly construed. In its decision, the Superior Court noted that “we must be mindful that evidentiary privileges are not favored.” It quoted from a higher court that stated “exceptions to the demand for evidence are not lightly created nor expansively construed, for they are in derogation of the search for the truth.” ■ Ann W. Latner, JD, a former criminal defense attorney, is a freelance medical writer in Port Washington, New York.

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www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • SEPTEMBER 2020 51