The Journal of Family Practice

ILLUSTRATIVE CASE

A 35-year-old healthy woman without a history of high-grade precancerous cervical lesions, immunodeficiency, or exposure to diethylstilbestrol presents to your office for her routine health visit. During your conversation with her, she shares, “I read on the Internet that I only need to be tested for human papillomavirus, but I’m wondering how I’ll be checked for cervical cancer.” She asks for your opinion about cervical cancer screening methods.

The National Cancer Institute predicts that there will be 13,800 new cases of cervical cancer this year, with an estimated 4290 deaths.³ This type of cancer is primarily caused by high-risk human papillomavirus (hrHPV) infections. Fortunately, high-grade precancerous cervical lesions and cervical cancer can be detected with routine Papanicolaou (Pap) smears, which have led to a substantial decrease in the number of deaths from cervical cancer in the United States—from 2.8 per 100,000 women in 2000 to 2.3 deaths per 100,000 women in 2015.³ In addition to hrHPV infection, risk factors for cervical cancer include low socioeconomic status, cigarette smoking, marrying before 18 years of age, young age at first coitus, multiple sexual partners, multiple sexual partners of a partner, and multiple childbirths.⁴

Cervical cancer is associated with numerous negative outcomes, including a decrease in quality of life, decreased libido, poor mental health, infertility, negative body image, and death.⁵ This is particularly true among women of lower socioeconomic status or whose language differs from that of their primary health care provider.^1,5

Given the enormous impact cervical cancer screening has made on the detection and mortality rate of this devastating disease,^4,5 it is crucial to identify the types of screening tests and screening intervals that lead to the greatest benefit and least harm for all patient populations. The US Preventive Services Task Force (USPSTF) previously addressed this issue in 2012, concluding that cytology alone every 3 years for women ages 21 to 65 years and cytology alone every 3 years or co-testing with cytology and hrHPV every 5 years in women ages 30 to 65 years was of substantial benefit (strength of recommendation [SOR]: A).⁶

STUDY SUMMARY

Another option for some women: hrHPV testing alone every 5 years

In this 2018 systematic review and modeling study by the USPSTF, randomized controlled trials (RCTs) and cohort studies that compared cytology to hrHPV testing alone or co-testing (cytology with hrHPV) were used to determine the optimal frequency of, and age group for, cervical cancer screening that would yield the least harm and the most benefit from each of these screening methods.^7-9

Similar to the previous recommendation, the USPSTF found that screening women < 21 years or > 65 years if previously adequately screened (defined as 3 consecutive negative screenings or 2 negative screenings within the past 10 years with the most recent being within the past 5 years) led to more harm than benefit. They therefore concluded that women in these age groups should not be screened routinely (SOR: D). The USPSTF also recommends against cervical cancer screening in women who have had a hysterectomy with removal of the cervix and who do not have a history of a high-grade precancerous lesion or cervical cancer (SOR: D).

Any 1 of 3 screening methods is adequately sensitive for detecting precancerous high-grade cervical lesions or cervical cancer in women ages 30 to 65 years.

However, for women ages 21 to 65 years, the USPSTF found that screening substantially reduces cervical cancer incidence and mortality, and that for women ages 21 to 29 years, screening every 3 years with cytology alone offers the best balance of benefits and harms (SOR: A). For women ages 30 to 65 years, the USPSTF recommends screening every 3 years with cytology alone or every 5 years with either primary hrHPV testing or co-testing (hrHPV with cytology) (SOR: A). The recommendations apply to all ­asymptomatic women with a cervix; exceptions include those with a history of a high-grade precancerous cervical lesion or cancer, in utero exposure to diethylstilbestrol, or a compromised immune system.

Continue to: The change

The change in this current set of recommendations by the USPSTF is the inclusion of screening with hrHPV alone every 5 years as an additional cervical cancer screening option for women ages 30 to 65 years. The decision to include this option was based largely on a decision analysis model commissioned by the USPSTF and reviewed along with clinical trials and cohort studies. The modeling studies found that both primary hrHPV testing alone and co-testing every 5 years prevented a similar number of cervical cancer cases and required a similar number of colposcopies.

Finally, the USPSTF emphasized that screening alone is not sufficient for the prevention of cervical cancer and that efforts should be made to create equitable access to follow-up of abnormal results and the provision of appropriate treatment.^1,2

WHAT’S NEW

When it comes to cervical cancer screening, 3 solid options now exist

The previous USPSTF recommendation concluded that women ages 30 to 65 years should be screened with either cytology alone every 3 years or co-testing (cytology and hrHPV) every 5 years. This systematic review and modeling study concluded that any one of the stated screening methods would be adequately sensitive for detecting precancerous high-grade cervical lesions or cervical cancer: cytology every 3 years, primary hrHPV every 5 years, or co-testing every 5 years.^7-9

CAVEATS

No studies comparing hrHPVto co-testing and no meta-analysis

No studies were found that directly compared primary hrHPV testing with co-testing.¹ A meta-analysis could not be performed due to the methodological differences in RCTs and cohort studies reviewed. The new recommendation is unique in its reliance on modeling to simulate a direct comparison of these 2 screening methods.

CHALLENGES TO IMPLEMENTATION

Getting the word out and increasing comfort levels

The principal challenge to implementation lies in practitioners’ knowledge of this new recommendation and a possible low comfort level with ordering hrHPV testing alone. Patients will need to be engaged in shared decision-making to understand and make use of the 3 options.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 35-year-old healthy woman without a history of high-grade precancerous cervical lesions, immunodeficiency, or exposure to diethylstilbestrol presents to your office for her routine health visit. During your conversation with her, she shares, “I read on the Internet that I only need to be tested for human papillomavirus, but I’m wondering how I’ll be checked for cervical cancer.” She asks for your opinion about cervical cancer screening methods.

The National Cancer Institute predicts that there will be 13,800 new cases of cervical cancer this year, with an estimated 4290 deaths.³ This type of cancer is primarily caused by high-risk human papillomavirus (hrHPV) infections. Fortunately, high-grade precancerous cervical lesions and cervical cancer can be detected with routine Papanicolaou (Pap) smears, which have led to a substantial decrease in the number of deaths from cervical cancer in the United States—from 2.8 per 100,000 women in 2000 to 2.3 deaths per 100,000 women in 2015.³ In addition to hrHPV infection, risk factors for cervical cancer include low socioeconomic status, cigarette smoking, marrying before 18 years of age, young age at first coitus, multiple sexual partners, multiple sexual partners of a partner, and multiple childbirths.⁴

Cervical cancer is associated with numerous negative outcomes, including a decrease in quality of life, decreased libido, poor mental health, infertility, negative body image, and death.⁵ This is particularly true among women of lower socioeconomic status or whose language differs from that of their primary health care provider.^1,5

Given the enormous impact cervical cancer screening has made on the detection and mortality rate of this devastating disease,^4,5 it is crucial to identify the types of screening tests and screening intervals that lead to the greatest benefit and least harm for all patient populations. The US Preventive Services Task Force (USPSTF) previously addressed this issue in 2012, concluding that cytology alone every 3 years for women ages 21 to 65 years and cytology alone every 3 years or co-testing with cytology and hrHPV every 5 years in women ages 30 to 65 years was of substantial benefit (strength of recommendation [SOR]: A).⁶

STUDY SUMMARY

Another option for some women: hrHPV testing alone every 5 years

In this 2018 systematic review and modeling study by the USPSTF, randomized controlled trials (RCTs) and cohort studies that compared cytology to hrHPV testing alone or co-testing (cytology with hrHPV) were used to determine the optimal frequency of, and age group for, cervical cancer screening that would yield the least harm and the most benefit from each of these screening methods.^7-9

Similar to the previous recommendation, the USPSTF found that screening women < 21 years or > 65 years if previously adequately screened (defined as 3 consecutive negative screenings or 2 negative screenings within the past 10 years with the most recent being within the past 5 years) led to more harm than benefit. They therefore concluded that women in these age groups should not be screened routinely (SOR: D). The USPSTF also recommends against cervical cancer screening in women who have had a hysterectomy with removal of the cervix and who do not have a history of a high-grade precancerous lesion or cervical cancer (SOR: D).

Any 1 of 3 screening methods is adequately sensitive for detecting precancerous high-grade cervical lesions or cervical cancer in women ages 30 to 65 years.

However, for women ages 21 to 65 years, the USPSTF found that screening substantially reduces cervical cancer incidence and mortality, and that for women ages 21 to 29 years, screening every 3 years with cytology alone offers the best balance of benefits and harms (SOR: A). For women ages 30 to 65 years, the USPSTF recommends screening every 3 years with cytology alone or every 5 years with either primary hrHPV testing or co-testing (hrHPV with cytology) (SOR: A). The recommendations apply to all ­asymptomatic women with a cervix; exceptions include those with a history of a high-grade precancerous cervical lesion or cancer, in utero exposure to diethylstilbestrol, or a compromised immune system.

Continue to: The change

The change in this current set of recommendations by the USPSTF is the inclusion of screening with hrHPV alone every 5 years as an additional cervical cancer screening option for women ages 30 to 65 years. The decision to include this option was based largely on a decision analysis model commissioned by the USPSTF and reviewed along with clinical trials and cohort studies. The modeling studies found that both primary hrHPV testing alone and co-testing every 5 years prevented a similar number of cervical cancer cases and required a similar number of colposcopies.

Finally, the USPSTF emphasized that screening alone is not sufficient for the prevention of cervical cancer and that efforts should be made to create equitable access to follow-up of abnormal results and the provision of appropriate treatment.^1,2

WHAT’S NEW

When it comes to cervical cancer screening, 3 solid options now exist

The previous USPSTF recommendation concluded that women ages 30 to 65 years should be screened with either cytology alone every 3 years or co-testing (cytology and hrHPV) every 5 years. This systematic review and modeling study concluded that any one of the stated screening methods would be adequately sensitive for detecting precancerous high-grade cervical lesions or cervical cancer: cytology every 3 years, primary hrHPV every 5 years, or co-testing every 5 years.^7-9

CAVEATS

No studies comparing hrHPVto co-testing and no meta-analysis

No studies were found that directly compared primary hrHPV testing with co-testing.¹ A meta-analysis could not be performed due to the methodological differences in RCTs and cohort studies reviewed. The new recommendation is unique in its reliance on modeling to simulate a direct comparison of these 2 screening methods.

CHALLENGES TO IMPLEMENTATION

Getting the word out and increasing comfort levels

The principal challenge to implementation lies in practitioners’ knowledge of this new recommendation and a possible low comfort level with ordering hrHPV testing alone. Patients will need to be engaged in shared decision-making to understand and make use of the 3 options.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 35-year-old healthy woman without a history of high-grade precancerous cervical lesions, immunodeficiency, or exposure to diethylstilbestrol presents to your office for her routine health visit. During your conversation with her, she shares, “I read on the Internet that I only need to be tested for human papillomavirus, but I’m wondering how I’ll be checked for cervical cancer.” She asks for your opinion about cervical cancer screening methods.

The National Cancer Institute predicts that there will be 13,800 new cases of cervical cancer this year, with an estimated 4290 deaths.³ This type of cancer is primarily caused by high-risk human papillomavirus (hrHPV) infections. Fortunately, high-grade precancerous cervical lesions and cervical cancer can be detected with routine Papanicolaou (Pap) smears, which have led to a substantial decrease in the number of deaths from cervical cancer in the United States—from 2.8 per 100,000 women in 2000 to 2.3 deaths per 100,000 women in 2015.³ In addition to hrHPV infection, risk factors for cervical cancer include low socioeconomic status, cigarette smoking, marrying before 18 years of age, young age at first coitus, multiple sexual partners, multiple sexual partners of a partner, and multiple childbirths.⁴

Cervical cancer is associated with numerous negative outcomes, including a decrease in quality of life, decreased libido, poor mental health, infertility, negative body image, and death.⁵ This is particularly true among women of lower socioeconomic status or whose language differs from that of their primary health care provider.^1,5

Given the enormous impact cervical cancer screening has made on the detection and mortality rate of this devastating disease,^4,5 it is crucial to identify the types of screening tests and screening intervals that lead to the greatest benefit and least harm for all patient populations. The US Preventive Services Task Force (USPSTF) previously addressed this issue in 2012, concluding that cytology alone every 3 years for women ages 21 to 65 years and cytology alone every 3 years or co-testing with cytology and hrHPV every 5 years in women ages 30 to 65 years was of substantial benefit (strength of recommendation [SOR]: A).⁶

STUDY SUMMARY

Another option for some women: hrHPV testing alone every 5 years

In this 2018 systematic review and modeling study by the USPSTF, randomized controlled trials (RCTs) and cohort studies that compared cytology to hrHPV testing alone or co-testing (cytology with hrHPV) were used to determine the optimal frequency of, and age group for, cervical cancer screening that would yield the least harm and the most benefit from each of these screening methods.^7-9

Similar to the previous recommendation, the USPSTF found that screening women < 21 years or > 65 years if previously adequately screened (defined as 3 consecutive negative screenings or 2 negative screenings within the past 10 years with the most recent being within the past 5 years) led to more harm than benefit. They therefore concluded that women in these age groups should not be screened routinely (SOR: D). The USPSTF also recommends against cervical cancer screening in women who have had a hysterectomy with removal of the cervix and who do not have a history of a high-grade precancerous lesion or cervical cancer (SOR: D).

Any 1 of 3 screening methods is adequately sensitive for detecting precancerous high-grade cervical lesions or cervical cancer in women ages 30 to 65 years.

However, for women ages 21 to 65 years, the USPSTF found that screening substantially reduces cervical cancer incidence and mortality, and that for women ages 21 to 29 years, screening every 3 years with cytology alone offers the best balance of benefits and harms (SOR: A). For women ages 30 to 65 years, the USPSTF recommends screening every 3 years with cytology alone or every 5 years with either primary hrHPV testing or co-testing (hrHPV with cytology) (SOR: A). The recommendations apply to all ­asymptomatic women with a cervix; exceptions include those with a history of a high-grade precancerous cervical lesion or cancer, in utero exposure to diethylstilbestrol, or a compromised immune system.

Continue to: The change

The change in this current set of recommendations by the USPSTF is the inclusion of screening with hrHPV alone every 5 years as an additional cervical cancer screening option for women ages 30 to 65 years. The decision to include this option was based largely on a decision analysis model commissioned by the USPSTF and reviewed along with clinical trials and cohort studies. The modeling studies found that both primary hrHPV testing alone and co-testing every 5 years prevented a similar number of cervical cancer cases and required a similar number of colposcopies.

Finally, the USPSTF emphasized that screening alone is not sufficient for the prevention of cervical cancer and that efforts should be made to create equitable access to follow-up of abnormal results and the provision of appropriate treatment.^1,2

WHAT’S NEW

When it comes to cervical cancer screening, 3 solid options now exist

The previous USPSTF recommendation concluded that women ages 30 to 65 years should be screened with either cytology alone every 3 years or co-testing (cytology and hrHPV) every 5 years. This systematic review and modeling study concluded that any one of the stated screening methods would be adequately sensitive for detecting precancerous high-grade cervical lesions or cervical cancer: cytology every 3 years, primary hrHPV every 5 years, or co-testing every 5 years.^7-9

CAVEATS

No studies comparing hrHPVto co-testing and no meta-analysis

No studies were found that directly compared primary hrHPV testing with co-testing.¹ A meta-analysis could not be performed due to the methodological differences in RCTs and cohort studies reviewed. The new recommendation is unique in its reliance on modeling to simulate a direct comparison of these 2 screening methods.

CHALLENGES TO IMPLEMENTATION

Getting the word out and increasing comfort levels

The principal challenge to implementation lies in practitioners’ knowledge of this new recommendation and a possible low comfort level with ordering hrHPV testing alone. Patients will need to be engaged in shared decision-making to understand and make use of the 3 options.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Which antibiotics are most useful for infection following ear piercing? When is it safe to attempt removal of a foreign body from the ear canal, and which cerumenolytic agent may be best for ear wax? This review covers common ailments of the outer ear, which are often readily diagnosed given a patient’s history and thorough physical examination. We also address more complicated matters such as deciding when to refer for treatment of suspected malignant otitis externa, and which lab markers to follow when managing it yourself.

A (very) brief review of ear anatomy

Understanding the unique embryology and intricate anatomy of the external ear informs our understanding of predictable infections, growths, and malformations.

The external ear is composed of the external auditory canal and auricle. The external auditory canal has a lateral (external) cartilaginous portion and a medial (internal) bony portion. The auricular structure is complex and formed by the helix, antihelix (crura; scaphoid fossa), tragus, antitragus, conchae, and lobule. The auricle is composed of elastic cartilage covered by skin. The lobule is composed of skin, adipose tissue, and connective tissue.

Embryologically, the auricle, auditory canal, and middle ear form from ectoderm of the first 2 branchial arches during early gestation. The auricle forms from the fusion of soft-tissue swellings (hillocks). Three hillocks arise from the first branchial arch and 3 from the second branchial arch during the fifth and sixth weeks of gestation. Tissues from the second branchial arch comprise the lobule, antihelix, and caudal helix. The cartilage of the tragus forms from the first branchial arch. The ear canal forms from an epithelial invagination of the first branchial arch that also occurs during the fifth week of gestation.¹

Infections

Perichondritis

Inflammation or infection of the connective tissue layer surrounding the auricular cartilage (perichondrium) results in perichondritis. Further extension of infection can lead to an auricular abscess. Both of these conditions can have serious consequences.

What you’ll see. The most common risk factor for perichondritis is the popular practice of cosmetic transcartilaginous piercing.² Piercing of the helix, scapha, or anti-helix (often referred to as “high” ear piercing) causes localized trauma that can strip the adjacent perichondrium, decrease blood supply, create cartilaginous microfractures, and lead to devascularization. Rates of infection as high as 35% have been reported with high-ear piercing.³

Rates of infection as high as 35% have been reported with high-ear piercing.

The most common microbes associated with perichondritis and pinna abscess formation are Pseudomonas and Staphylococcus species.² P aeruginosa accounts for a majority (87%) of post-piercing infections of the auricular cartilage.²

Continue to: How to treat

How to treat. The cornerstone of treatment is early detection and antimicrobial coverage with antipseudomonal antibiotics. Ciprofloxacin is the oral antibiotic of choice because of its ability to penetrate the tissue.⁴ Other options include clindamycin and third- or fourth-generation cephalosporins. If the wound becomes abscessed, ­perform (or refer for) early surgical incision and drainage.⁵ A failure to promptly recognize perichondritis or to mistakenly prescribe non-­antipseudomonal antibiotics contributes to increased rates of hospitalization.² Cosmetic deformity is the most common complication of perichondritis. This may require reconstructive surgery.

Otitis externa

Acute otitis externa (AOE; “swimmer’s ear”) is cellulitis of the skin and subdermis of the external ear canal. It is most prevalent in warm, moist climates and almost always associated with acute bacterial infection, most commonly P aeruginosa or S aureus.⁶ There is also an increased association with poor water quality (containing higher bacterial loads). Anything breaching the integrity of the ear canal can potentially predispose to the development of AOE. This includes trauma from cleaning, cerumen removal, scratching due to allergic conditions, and placement of hearing-aid devices.⁶

What you’ll see. Suspect AOE when signs or symptoms of ear canal inflammation have appeared rapidly (generally within 2 days) over the past 3 weeks.⁷ Findings include otalgia, itching, fullness, tragal tenderness, ear canal edema, erythema with or without otorrhea, lymphadenitis, or cellulitis of the pinna or adjacent skin.⁷ AOE must be distinguished from other causes of otalgia and otorrhea, including dermatitis and viral infection.

How to treat. Topical therapy is recommended for the initial treatment of uncomplicated AOE, usually given over 7 days. Multiple topical preparations are available, such as ciprofloxacin 0.2%/hydrocortisone 1.0%; neomycin/polymyxin B/hydrocortisone; ofloxacin 0.3%; or acetic acid 2.0%.⁷ Avoid these agents, though, if you suspect tympanic membrane rupture. Quinolone drops are the only topical antimicrobials approved for middle ear use.⁷

Systemic antibiotics are not recommended for the initial treatment of AOE. Topical agents deliver a much higher concentration of medication than can be achieved systemically. Consider systemic antibiotics if there is extension outside the ear canal, a concern for necrotizing otitis externa (more on this in a bit), or the patient is immunodeficient.⁸

Continue to: Patient (or parent) education...

Patient (or parent) education is important to ensure proper medication administration. The patient should lie down with the affected ear facing up. After the canal is filled with drops, the patient should remain in this position for 3 to 5 minutes. Gently massaging the tragus can augment delivery. Patients should keep the ear canal as dry as possible and avoid inserting objects (eg, hearing aids, ear buds, cotton-tipped applicators) into the canal for the duration of treatment. The delivery of topical antibiotics can be enhanced by wick placement. Prescribe analgesics (typically nonsteroidal anti-inflammatory agents) based on severity of pain.⁷

Have patients abstain from water sports for 7 to 10 days. Showering is acceptable with minimal ear exposure to water; bathing is preferred when possible. If there is no clinical improvement in 48 to 72 hours, ask patients to return for re-evaluation.⁸ Prevention is essential for patients with a history of recurrent otitis externa. Acetic acid solutions create an acidic environment within the canal to help prevent recurrent AOE. Ear plugs and petroleum jelly–soaked cotton plugs prior to water exposure may also help prevent recurrent AOE.

Malignant otitis externa

Malignant, or necrotizing, otitis externa is an aggressive disease form of otitis externa that is most common in individuals with diabetes or other immunodeficiency disorders.⁹ Most cases are due to infection with P aeruginosa.¹⁰ Prior to the availability of effective antibiotics, mortality rates in patients with necrotizing otitis externa were as high as 50%.¹¹

What you’ll see. Patients typically present with severe ear pain, otorrhea, conductive hearing loss, and a feeling of fullness in the external ear canal. Physical examination reveals purulent otorrhea and a swollen, tender ear canal. Exposed bone may be visible, most often on the floor of the canal. The tympanic membrane and middle ear are seldom involved on initial presentation.

The infection often originates at the junction of the bony and cartilaginous portion of the external canal, spreading through the fissures of Santorini to the skull base. If not aggressively treated, the infection spreads medially to the tympanomastoid suture causing intracranial complications—usually a facial nerve neuropathy.

Continue to: Given these clinical findings...

Given these clinical findings, promptly order laboratory studies and imaging to confirm the diagnosis. The erythrocyte sedimentation rate and C-reactive protein level are typically elevated, and either can be used as a marker to follow treatment. Computed tomography (CT) helps to determine the location and extent of disease and is recommended as the initial diagnostic imaging modality for patients with suspected malignant otitis externa.¹²

Magnetic resonance imaging helps define soft-tissue changes, dural enhancement, and involvement of medullary bone, making this the preferred modality to monitor therapeutic response.¹² Technetium bone scanning can also be used for the initial diagnosis (particularly if CT findings are normal and clinical suspicion is high) and for follow-up with treatment.

How to treat. Management involves a team approach with otolaryngology, radiology, neurology, endocrinology, and infectious disease specialists. Long term (6-8 weeks) antipseudomonal antibiotic treatment is typical.

In head-to-head laboratory comparisons, distilled water appears to be the best cerumenolytic.

Let culture results guide the choice of antibiotic. Fluoroquinolone therapy, usually ciprofloxacin, is used most often.¹² Surgical intervention may be required for local debridement and drainage of abscesses. Close follow-up is necessary due to reports of recurrence up to 1 year after treatment. If left untreated, necrotizing otitis externa can lead to osteomyelitis, meningitis, septic thrombosis, cerebral abscess, and death.¹¹

Cerumen impaction

The relatively small diameter of the external auditory canal increases the risk for impaction of cerumen and foreign bodies. Cerumen impaction, in particular, is a common primary care complaint. Cerumen forms when glandular secretions from the outer two-thirds of the ear canal mix with exfoliated skin. It functions as a lubricant for the ear canal and as a barrier against infection, water accumulation, and foreign bodies.¹³

Continue to: What you'll see

What you’ll see. You may encounter cerumen impaction in an asymptomatic patient when it prevents visualization of the external auditory canal or tympanic membrane, or when a patient complains of conductive hearing loss, tinnitus, dizziness, ear pain, itching, and cough.¹³ It is found in 1 in 10 children and 1 in 20 adults.¹³ There is a higher incidence in patients who are elderly, are cognitively impaired, or wear hearing devices or ear plugs.^13,14 Asymptomatic cerumen impaction should not be treated. A recent clinical guideline provides a useful “do and don’t” list for patient education (TABLE).¹³

How to treat. In asymptomatic patients, the presence of cerumen on examination is not an indication for removal. Based on current guidelines,¹³ impacted cerumen can safely be removed from the ear canal of symptomatic patients in several ways:

• Manual removal with cerumen loop/spoon or alligator forceps. This method decreases the risk for infection because it limits moisture exposure. However, it should be performed by a health care provider trained in its use because of the risk for trauma to the ear canal and tympanic membrane.
• Irrigation of the ear using tap water or a 50-50 solution of hydrogen peroxide and water. Irrigation can be achieved with a syringe or jet irrigator using a modified tip. This method also has a risk for trauma to the ear canal and tympanic membrane and should only be performed by appropriately trained health care professionals.
• Use of cerumenolytic agents to soften and thin earwax and promote natural extrusion. Several types of cerumenolytic drops (water-based and oil-based) are available and appear to be equally effective. Water-based solutions contain hydrogen peroxide, docusate sodium, acetic acid, and sodium bicarbonate. Oil-based drops may contain peanut, almond, or olive oils. A thorough allergic history should be performed to avoid using products in patients with nut allergies. In head-to-head laboratory comparisons, distilled water appears to be the best cerumenolytic.¹⁵

Foreign bodies

Foreign bodies in the external auditory canal (typically beads, cotton tips, and insects) are more common in children than adults.¹⁶

What you’ll see. Most foreign bodies are lodged in the bony part of the external auditory canal, and many patients try to remove the object before seeking medical care. Removal requires adequate visualization and skill.¹⁷ Although patients may be asymptomatic, most complain of pain, fullness, decreased hearing, or otorrhea.

How to treat. Directly visible objects can often be removed without referral. Suction, irrigation, forceps, probes, and fine hooks have been used. Insect removal can be facilitated by first flooding the canal with xylocaine, alcohol, or mineral oil. Acetone may be used to dissolve foreign bodies containing Styrofoam or to loosen glues. If the object is a button battery, avoid irrigation to prevent liquefaction tissue necrosis.

Continue to: Complications of foreign body removal...

Insect removal can be facilitated by first flooding the canal with xylocaine, alcohol, or mineral oil.

Complications of foreign body removal include pain, otitis externa, otitis media, and trauma to the ear or tympanic membrane. The likelihood of successful removal of the object decreases and the risk for complications increases with each subsequent attempt.¹⁷ Consult an otolaryngologist if sedation or anesthesia is required, the foreign body is tightly wedged, there is trauma to the ear canal or tympanic membrane, the foreign body has a sharp edge (eg, glass or wire), or removal attempts have been unsuccessful.

Trauma

Sports injuries, motor vehicle accidents, bites, falls, and burns are the primary causes of trauma to the external ear.¹⁸

What you’ll see. Blunt auricular trauma predisposes to infection, necrosis, and scar contracture. One of the most common sequelae is cauliflower ear. Trauma is particularly common with contact sports such as boxing, wrestling, or mixed martial arts. The skin of the auricle attaches directly to the perichondrium. Following blunt or shearing trauma to the auricle, hematomas form within the space between the perichondrium and cartilage of the anterior ear.¹⁹Following hematoma formation, the healing process brings chondrocytes and fibroblasts to the subperichondrial space, promoting fibrocartilage formation. Over time (and with repeated injury), this can lead to a chronic, bulbous deformity known as cauliflower ear.

How to treat. Small hematomas can be managed by aspiration, while larger ones generally require open drainage.²⁰ Newer treatments involving pressure dressings and the use of fibrin glue have been proposed.²⁰ Recommend that athletes participating in contact sports wear appropriate protective headgear to prevent auricular hematoma and cauliflower ear.

Neoplasm

Roughly 5% of all skin cancers involve the ear, most frequently the pinna due to chronic sun exposure.²¹ The most frequently occurring malignancy of the external ear is basal cell carcinoma (BCC), which is responsible for 80% of all nonmelanoma skin cancers.²²

Continue to: What you'll see

What you’ll see. BCC of the ear usually involves the preauricular area and the helix. The risk for BCC is related to exposure to ultraviolet radiation. BCC of the ear is more common in men and can be particularly aggressive, highlighting the importance of prevention and prompt recognition. BCC typically presents as a fleshy papule that is often translucent or “pearly’” and has overlying telangiectasia and a “rolled” border. Central ulceration can occur as well.

How to treat. Usual treatment of BCC is surgical excision. Prevention is critical and centers on sun avoidance or the use of appropriate sunscreens.

If the object in the external auditory canal is a button battery, avoid irrigation to prevent liquefaction tissue necrosis.

In addition to BCC, exposure of the external ear to sunlight and ultraviolet radiation predisposes patients to the development of squamous cell carcinoma (SCC) and melanoma. SCC has a variety of presentations including papules, plaques, and nodules. SCC has a higher metastatic potential than does BCC.

Keloid

Keloids are an abnormal healing response to soft-tissue injury: benign fibrocartilaginous growths that extend beyond the original wound.

What you’ll see. Keloids are more common in dark-skinned individuals and tend to result from burns, surgical incisions, infection, trauma, tattooing, injections, piercings, and arthropod bites. In some cases, they arise spontaneously. Keloids are more common in areas of increased skin tension (chest, shoulders, back), but may occur on the ears—most commonly after piercing or trauma. Keloids present clinically as slow-growing rubbery or firm nodules. The diagnosis is typically based on clinical appearance but can be confirmed by histopathology.

Continue to: How to treat

How to treat. Treatments vary and include observation, excision, intralesional injections, cryotherapy, enzyme therapy, silicone gel application, and irradiation.²³ Recurrence is common; no therapy has been proven to be universally superior or preferred.

Congenital malformations

Atresia

Disruption of embryologic development (failed invagination of the external auditory canal) can lead to a stenotic or absent ear canal (aural atresia). Aural atresia is also often associated with fusion of the incus and malleus. This condition occurs predominantly in males. Unilateral atresia is more common than bilateral atresia, and the right ear is more often involved than the left.²⁴

Microtia

Microtia is the incomplete development of the pinna leading to a small or deformed pinna. Microtia can be unilateral or bilateral. As with atresia, microtia more commonly affects males and, if unilateral, the right side is more often affected than the left. Microtia can occur in isolation but is often associated with genetic syndromes such as Treacher Collins syndrome and craniofacial microsomia (Goldenhar syndrome). When microtia is identified (typically at birth or early infancy), audiologic testing and a thorough physical examination for evidence of associated defects should be performed. Consult with an audiologist, clinical geneticist, or pediatric otolaryngologist.

Pre-auricular pits

Pre-auricular pits (sinuses) are tiny indentations anterior to the helix and superior to the tragus. While pre-auricular pits are more common on the right side, they are bilateral in 25% to 50% of cases.²⁵ Pre-auricular pits occur in up to 1% of white children, 5% of black children, and 10% of Asian children.²⁵ Children with this condition should undergo formal audiologic testing as their risk for hearing loss is higher compared with the general population.²⁶

Directly visible foreign objects can often be removed without referral, but the likelihood of success decreases with each subsequent attempt.

The branchio-oto-renal syndrome (associated with pre-auricular pits and hearing loss) also features structural defects of the ear, renal anomalies and/or nasolacrimal duct stenosis or fistulas. If this syndrome is suspected, renal ultrasound imaging is warranted. Other indications for renal ultrasound in patients with a pre-auricular pit are any dysmorphic feature, a family history of deafness, an auricular malformation, or a maternal history of gestational diabetes.²⁷ Pre-auricular pits do not require surgery unless they drain chronically or become recurrently infected. Complete surgical excision is the treatment of choice in these cases.

CORRESPONDENCE 
Mark Stephens, MD, 1850 Park Avenue, State College, PA 16801; mstephens3@pennstatehealth.psu.edu

Which antibiotics are most useful for infection following ear piercing? When is it safe to attempt removal of a foreign body from the ear canal, and which cerumenolytic agent may be best for ear wax? This review covers common ailments of the outer ear, which are often readily diagnosed given a patient’s history and thorough physical examination. We also address more complicated matters such as deciding when to refer for treatment of suspected malignant otitis externa, and which lab markers to follow when managing it yourself.

A (very) brief review of ear anatomy

Understanding the unique embryology and intricate anatomy of the external ear informs our understanding of predictable infections, growths, and malformations.

The external ear is composed of the external auditory canal and auricle. The external auditory canal has a lateral (external) cartilaginous portion and a medial (internal) bony portion. The auricular structure is complex and formed by the helix, antihelix (crura; scaphoid fossa), tragus, antitragus, conchae, and lobule. The auricle is composed of elastic cartilage covered by skin. The lobule is composed of skin, adipose tissue, and connective tissue.

Embryologically, the auricle, auditory canal, and middle ear form from ectoderm of the first 2 branchial arches during early gestation. The auricle forms from the fusion of soft-tissue swellings (hillocks). Three hillocks arise from the first branchial arch and 3 from the second branchial arch during the fifth and sixth weeks of gestation. Tissues from the second branchial arch comprise the lobule, antihelix, and caudal helix. The cartilage of the tragus forms from the first branchial arch. The ear canal forms from an epithelial invagination of the first branchial arch that also occurs during the fifth week of gestation.¹

Infections

Perichondritis

Inflammation or infection of the connective tissue layer surrounding the auricular cartilage (perichondrium) results in perichondritis. Further extension of infection can lead to an auricular abscess. Both of these conditions can have serious consequences.

What you’ll see. The most common risk factor for perichondritis is the popular practice of cosmetic transcartilaginous piercing.² Piercing of the helix, scapha, or anti-helix (often referred to as “high” ear piercing) causes localized trauma that can strip the adjacent perichondrium, decrease blood supply, create cartilaginous microfractures, and lead to devascularization. Rates of infection as high as 35% have been reported with high-ear piercing.³

Rates of infection as high as 35% have been reported with high-ear piercing.

The most common microbes associated with perichondritis and pinna abscess formation are Pseudomonas and Staphylococcus species.² P aeruginosa accounts for a majority (87%) of post-piercing infections of the auricular cartilage.²

Continue to: How to treat

How to treat. The cornerstone of treatment is early detection and antimicrobial coverage with antipseudomonal antibiotics. Ciprofloxacin is the oral antibiotic of choice because of its ability to penetrate the tissue.⁴ Other options include clindamycin and third- or fourth-generation cephalosporins. If the wound becomes abscessed, ­perform (or refer for) early surgical incision and drainage.⁵ A failure to promptly recognize perichondritis or to mistakenly prescribe non-­antipseudomonal antibiotics contributes to increased rates of hospitalization.² Cosmetic deformity is the most common complication of perichondritis. This may require reconstructive surgery.

Otitis externa

Acute otitis externa (AOE; “swimmer’s ear”) is cellulitis of the skin and subdermis of the external ear canal. It is most prevalent in warm, moist climates and almost always associated with acute bacterial infection, most commonly P aeruginosa or S aureus.⁶ There is also an increased association with poor water quality (containing higher bacterial loads). Anything breaching the integrity of the ear canal can potentially predispose to the development of AOE. This includes trauma from cleaning, cerumen removal, scratching due to allergic conditions, and placement of hearing-aid devices.⁶

What you’ll see. Suspect AOE when signs or symptoms of ear canal inflammation have appeared rapidly (generally within 2 days) over the past 3 weeks.⁷ Findings include otalgia, itching, fullness, tragal tenderness, ear canal edema, erythema with or without otorrhea, lymphadenitis, or cellulitis of the pinna or adjacent skin.⁷ AOE must be distinguished from other causes of otalgia and otorrhea, including dermatitis and viral infection.

How to treat. Topical therapy is recommended for the initial treatment of uncomplicated AOE, usually given over 7 days. Multiple topical preparations are available, such as ciprofloxacin 0.2%/hydrocortisone 1.0%; neomycin/polymyxin B/hydrocortisone; ofloxacin 0.3%; or acetic acid 2.0%.⁷ Avoid these agents, though, if you suspect tympanic membrane rupture. Quinolone drops are the only topical antimicrobials approved for middle ear use.⁷

Systemic antibiotics are not recommended for the initial treatment of AOE. Topical agents deliver a much higher concentration of medication than can be achieved systemically. Consider systemic antibiotics if there is extension outside the ear canal, a concern for necrotizing otitis externa (more on this in a bit), or the patient is immunodeficient.⁸

Continue to: Patient (or parent) education...

Patient (or parent) education is important to ensure proper medication administration. The patient should lie down with the affected ear facing up. After the canal is filled with drops, the patient should remain in this position for 3 to 5 minutes. Gently massaging the tragus can augment delivery. Patients should keep the ear canal as dry as possible and avoid inserting objects (eg, hearing aids, ear buds, cotton-tipped applicators) into the canal for the duration of treatment. The delivery of topical antibiotics can be enhanced by wick placement. Prescribe analgesics (typically nonsteroidal anti-inflammatory agents) based on severity of pain.⁷

Have patients abstain from water sports for 7 to 10 days. Showering is acceptable with minimal ear exposure to water; bathing is preferred when possible. If there is no clinical improvement in 48 to 72 hours, ask patients to return for re-evaluation.⁸ Prevention is essential for patients with a history of recurrent otitis externa. Acetic acid solutions create an acidic environment within the canal to help prevent recurrent AOE. Ear plugs and petroleum jelly–soaked cotton plugs prior to water exposure may also help prevent recurrent AOE.

Malignant otitis externa

Malignant, or necrotizing, otitis externa is an aggressive disease form of otitis externa that is most common in individuals with diabetes or other immunodeficiency disorders.⁹ Most cases are due to infection with P aeruginosa.¹⁰ Prior to the availability of effective antibiotics, mortality rates in patients with necrotizing otitis externa were as high as 50%.¹¹

What you’ll see. Patients typically present with severe ear pain, otorrhea, conductive hearing loss, and a feeling of fullness in the external ear canal. Physical examination reveals purulent otorrhea and a swollen, tender ear canal. Exposed bone may be visible, most often on the floor of the canal. The tympanic membrane and middle ear are seldom involved on initial presentation.

The infection often originates at the junction of the bony and cartilaginous portion of the external canal, spreading through the fissures of Santorini to the skull base. If not aggressively treated, the infection spreads medially to the tympanomastoid suture causing intracranial complications—usually a facial nerve neuropathy.

Continue to: Given these clinical findings...

Given these clinical findings, promptly order laboratory studies and imaging to confirm the diagnosis. The erythrocyte sedimentation rate and C-reactive protein level are typically elevated, and either can be used as a marker to follow treatment. Computed tomography (CT) helps to determine the location and extent of disease and is recommended as the initial diagnostic imaging modality for patients with suspected malignant otitis externa.¹²

Magnetic resonance imaging helps define soft-tissue changes, dural enhancement, and involvement of medullary bone, making this the preferred modality to monitor therapeutic response.¹² Technetium bone scanning can also be used for the initial diagnosis (particularly if CT findings are normal and clinical suspicion is high) and for follow-up with treatment.

How to treat. Management involves a team approach with otolaryngology, radiology, neurology, endocrinology, and infectious disease specialists. Long term (6-8 weeks) antipseudomonal antibiotic treatment is typical.

In head-to-head laboratory comparisons, distilled water appears to be the best cerumenolytic.

Let culture results guide the choice of antibiotic. Fluoroquinolone therapy, usually ciprofloxacin, is used most often.¹² Surgical intervention may be required for local debridement and drainage of abscesses. Close follow-up is necessary due to reports of recurrence up to 1 year after treatment. If left untreated, necrotizing otitis externa can lead to osteomyelitis, meningitis, septic thrombosis, cerebral abscess, and death.¹¹

Cerumen impaction

The relatively small diameter of the external auditory canal increases the risk for impaction of cerumen and foreign bodies. Cerumen impaction, in particular, is a common primary care complaint. Cerumen forms when glandular secretions from the outer two-thirds of the ear canal mix with exfoliated skin. It functions as a lubricant for the ear canal and as a barrier against infection, water accumulation, and foreign bodies.¹³

Continue to: What you'll see

What you’ll see. You may encounter cerumen impaction in an asymptomatic patient when it prevents visualization of the external auditory canal or tympanic membrane, or when a patient complains of conductive hearing loss, tinnitus, dizziness, ear pain, itching, and cough.¹³ It is found in 1 in 10 children and 1 in 20 adults.¹³ There is a higher incidence in patients who are elderly, are cognitively impaired, or wear hearing devices or ear plugs.^13,14 Asymptomatic cerumen impaction should not be treated. A recent clinical guideline provides a useful “do and don’t” list for patient education (TABLE).¹³

How to treat. In asymptomatic patients, the presence of cerumen on examination is not an indication for removal. Based on current guidelines,¹³ impacted cerumen can safely be removed from the ear canal of symptomatic patients in several ways:

• Manual removal with cerumen loop/spoon or alligator forceps. This method decreases the risk for infection because it limits moisture exposure. However, it should be performed by a health care provider trained in its use because of the risk for trauma to the ear canal and tympanic membrane.
• Irrigation of the ear using tap water or a 50-50 solution of hydrogen peroxide and water. Irrigation can be achieved with a syringe or jet irrigator using a modified tip. This method also has a risk for trauma to the ear canal and tympanic membrane and should only be performed by appropriately trained health care professionals.
• Use of cerumenolytic agents to soften and thin earwax and promote natural extrusion. Several types of cerumenolytic drops (water-based and oil-based) are available and appear to be equally effective. Water-based solutions contain hydrogen peroxide, docusate sodium, acetic acid, and sodium bicarbonate. Oil-based drops may contain peanut, almond, or olive oils. A thorough allergic history should be performed to avoid using products in patients with nut allergies. In head-to-head laboratory comparisons, distilled water appears to be the best cerumenolytic.¹⁵

Foreign bodies

Foreign bodies in the external auditory canal (typically beads, cotton tips, and insects) are more common in children than adults.¹⁶

What you’ll see. Most foreign bodies are lodged in the bony part of the external auditory canal, and many patients try to remove the object before seeking medical care. Removal requires adequate visualization and skill.¹⁷ Although patients may be asymptomatic, most complain of pain, fullness, decreased hearing, or otorrhea.

How to treat. Directly visible objects can often be removed without referral. Suction, irrigation, forceps, probes, and fine hooks have been used. Insect removal can be facilitated by first flooding the canal with xylocaine, alcohol, or mineral oil. Acetone may be used to dissolve foreign bodies containing Styrofoam or to loosen glues. If the object is a button battery, avoid irrigation to prevent liquefaction tissue necrosis.

Continue to: Complications of foreign body removal...

Insect removal can be facilitated by first flooding the canal with xylocaine, alcohol, or mineral oil.

Complications of foreign body removal include pain, otitis externa, otitis media, and trauma to the ear or tympanic membrane. The likelihood of successful removal of the object decreases and the risk for complications increases with each subsequent attempt.¹⁷ Consult an otolaryngologist if sedation or anesthesia is required, the foreign body is tightly wedged, there is trauma to the ear canal or tympanic membrane, the foreign body has a sharp edge (eg, glass or wire), or removal attempts have been unsuccessful.

Trauma

Sports injuries, motor vehicle accidents, bites, falls, and burns are the primary causes of trauma to the external ear.¹⁸

What you’ll see. Blunt auricular trauma predisposes to infection, necrosis, and scar contracture. One of the most common sequelae is cauliflower ear. Trauma is particularly common with contact sports such as boxing, wrestling, or mixed martial arts. The skin of the auricle attaches directly to the perichondrium. Following blunt or shearing trauma to the auricle, hematomas form within the space between the perichondrium and cartilage of the anterior ear.¹⁹Following hematoma formation, the healing process brings chondrocytes and fibroblasts to the subperichondrial space, promoting fibrocartilage formation. Over time (and with repeated injury), this can lead to a chronic, bulbous deformity known as cauliflower ear.

How to treat. Small hematomas can be managed by aspiration, while larger ones generally require open drainage.²⁰ Newer treatments involving pressure dressings and the use of fibrin glue have been proposed.²⁰ Recommend that athletes participating in contact sports wear appropriate protective headgear to prevent auricular hematoma and cauliflower ear.

Neoplasm

Roughly 5% of all skin cancers involve the ear, most frequently the pinna due to chronic sun exposure.²¹ The most frequently occurring malignancy of the external ear is basal cell carcinoma (BCC), which is responsible for 80% of all nonmelanoma skin cancers.²²

Continue to: What you'll see

What you’ll see. BCC of the ear usually involves the preauricular area and the helix. The risk for BCC is related to exposure to ultraviolet radiation. BCC of the ear is more common in men and can be particularly aggressive, highlighting the importance of prevention and prompt recognition. BCC typically presents as a fleshy papule that is often translucent or “pearly’” and has overlying telangiectasia and a “rolled” border. Central ulceration can occur as well.

How to treat. Usual treatment of BCC is surgical excision. Prevention is critical and centers on sun avoidance or the use of appropriate sunscreens.

If the object in the external auditory canal is a button battery, avoid irrigation to prevent liquefaction tissue necrosis.

In addition to BCC, exposure of the external ear to sunlight and ultraviolet radiation predisposes patients to the development of squamous cell carcinoma (SCC) and melanoma. SCC has a variety of presentations including papules, plaques, and nodules. SCC has a higher metastatic potential than does BCC.

Keloid

Keloids are an abnormal healing response to soft-tissue injury: benign fibrocartilaginous growths that extend beyond the original wound.

What you’ll see. Keloids are more common in dark-skinned individuals and tend to result from burns, surgical incisions, infection, trauma, tattooing, injections, piercings, and arthropod bites. In some cases, they arise spontaneously. Keloids are more common in areas of increased skin tension (chest, shoulders, back), but may occur on the ears—most commonly after piercing or trauma. Keloids present clinically as slow-growing rubbery or firm nodules. The diagnosis is typically based on clinical appearance but can be confirmed by histopathology.

Continue to: How to treat

How to treat. Treatments vary and include observation, excision, intralesional injections, cryotherapy, enzyme therapy, silicone gel application, and irradiation.²³ Recurrence is common; no therapy has been proven to be universally superior or preferred.

Congenital malformations

Atresia

Disruption of embryologic development (failed invagination of the external auditory canal) can lead to a stenotic or absent ear canal (aural atresia). Aural atresia is also often associated with fusion of the incus and malleus. This condition occurs predominantly in males. Unilateral atresia is more common than bilateral atresia, and the right ear is more often involved than the left.²⁴

Microtia

Microtia is the incomplete development of the pinna leading to a small or deformed pinna. Microtia can be unilateral or bilateral. As with atresia, microtia more commonly affects males and, if unilateral, the right side is more often affected than the left. Microtia can occur in isolation but is often associated with genetic syndromes such as Treacher Collins syndrome and craniofacial microsomia (Goldenhar syndrome). When microtia is identified (typically at birth or early infancy), audiologic testing and a thorough physical examination for evidence of associated defects should be performed. Consult with an audiologist, clinical geneticist, or pediatric otolaryngologist.

Pre-auricular pits

Pre-auricular pits (sinuses) are tiny indentations anterior to the helix and superior to the tragus. While pre-auricular pits are more common on the right side, they are bilateral in 25% to 50% of cases.²⁵ Pre-auricular pits occur in up to 1% of white children, 5% of black children, and 10% of Asian children.²⁵ Children with this condition should undergo formal audiologic testing as their risk for hearing loss is higher compared with the general population.²⁶

Directly visible foreign objects can often be removed without referral, but the likelihood of success decreases with each subsequent attempt.

The branchio-oto-renal syndrome (associated with pre-auricular pits and hearing loss) also features structural defects of the ear, renal anomalies and/or nasolacrimal duct stenosis or fistulas. If this syndrome is suspected, renal ultrasound imaging is warranted. Other indications for renal ultrasound in patients with a pre-auricular pit are any dysmorphic feature, a family history of deafness, an auricular malformation, or a maternal history of gestational diabetes.²⁷ Pre-auricular pits do not require surgery unless they drain chronically or become recurrently infected. Complete surgical excision is the treatment of choice in these cases.

CORRESPONDENCE 
Mark Stephens, MD, 1850 Park Avenue, State College, PA 16801; mstephens3@pennstatehealth.psu.edu

Which antibiotics are most useful for infection following ear piercing? When is it safe to attempt removal of a foreign body from the ear canal, and which cerumenolytic agent may be best for ear wax? This review covers common ailments of the outer ear, which are often readily diagnosed given a patient’s history and thorough physical examination. We also address more complicated matters such as deciding when to refer for treatment of suspected malignant otitis externa, and which lab markers to follow when managing it yourself.

A (very) brief review of ear anatomy

Understanding the unique embryology and intricate anatomy of the external ear informs our understanding of predictable infections, growths, and malformations.

The external ear is composed of the external auditory canal and auricle. The external auditory canal has a lateral (external) cartilaginous portion and a medial (internal) bony portion. The auricular structure is complex and formed by the helix, antihelix (crura; scaphoid fossa), tragus, antitragus, conchae, and lobule. The auricle is composed of elastic cartilage covered by skin. The lobule is composed of skin, adipose tissue, and connective tissue.

Embryologically, the auricle, auditory canal, and middle ear form from ectoderm of the first 2 branchial arches during early gestation. The auricle forms from the fusion of soft-tissue swellings (hillocks). Three hillocks arise from the first branchial arch and 3 from the second branchial arch during the fifth and sixth weeks of gestation. Tissues from the second branchial arch comprise the lobule, antihelix, and caudal helix. The cartilage of the tragus forms from the first branchial arch. The ear canal forms from an epithelial invagination of the first branchial arch that also occurs during the fifth week of gestation.¹

Infections

Perichondritis

Inflammation or infection of the connective tissue layer surrounding the auricular cartilage (perichondrium) results in perichondritis. Further extension of infection can lead to an auricular abscess. Both of these conditions can have serious consequences.

What you’ll see. The most common risk factor for perichondritis is the popular practice of cosmetic transcartilaginous piercing.² Piercing of the helix, scapha, or anti-helix (often referred to as “high” ear piercing) causes localized trauma that can strip the adjacent perichondrium, decrease blood supply, create cartilaginous microfractures, and lead to devascularization. Rates of infection as high as 35% have been reported with high-ear piercing.³

Rates of infection as high as 35% have been reported with high-ear piercing.

The most common microbes associated with perichondritis and pinna abscess formation are Pseudomonas and Staphylococcus species.² P aeruginosa accounts for a majority (87%) of post-piercing infections of the auricular cartilage.²

Continue to: How to treat

How to treat. The cornerstone of treatment is early detection and antimicrobial coverage with antipseudomonal antibiotics. Ciprofloxacin is the oral antibiotic of choice because of its ability to penetrate the tissue.⁴ Other options include clindamycin and third- or fourth-generation cephalosporins. If the wound becomes abscessed, ­perform (or refer for) early surgical incision and drainage.⁵ A failure to promptly recognize perichondritis or to mistakenly prescribe non-­antipseudomonal antibiotics contributes to increased rates of hospitalization.² Cosmetic deformity is the most common complication of perichondritis. This may require reconstructive surgery.

Otitis externa

Acute otitis externa (AOE; “swimmer’s ear”) is cellulitis of the skin and subdermis of the external ear canal. It is most prevalent in warm, moist climates and almost always associated with acute bacterial infection, most commonly P aeruginosa or S aureus.⁶ There is also an increased association with poor water quality (containing higher bacterial loads). Anything breaching the integrity of the ear canal can potentially predispose to the development of AOE. This includes trauma from cleaning, cerumen removal, scratching due to allergic conditions, and placement of hearing-aid devices.⁶

What you’ll see. Suspect AOE when signs or symptoms of ear canal inflammation have appeared rapidly (generally within 2 days) over the past 3 weeks.⁷ Findings include otalgia, itching, fullness, tragal tenderness, ear canal edema, erythema with or without otorrhea, lymphadenitis, or cellulitis of the pinna or adjacent skin.⁷ AOE must be distinguished from other causes of otalgia and otorrhea, including dermatitis and viral infection.

How to treat. Topical therapy is recommended for the initial treatment of uncomplicated AOE, usually given over 7 days. Multiple topical preparations are available, such as ciprofloxacin 0.2%/hydrocortisone 1.0%; neomycin/polymyxin B/hydrocortisone; ofloxacin 0.3%; or acetic acid 2.0%.⁷ Avoid these agents, though, if you suspect tympanic membrane rupture. Quinolone drops are the only topical antimicrobials approved for middle ear use.⁷

Systemic antibiotics are not recommended for the initial treatment of AOE. Topical agents deliver a much higher concentration of medication than can be achieved systemically. Consider systemic antibiotics if there is extension outside the ear canal, a concern for necrotizing otitis externa (more on this in a bit), or the patient is immunodeficient.⁸

Continue to: Patient (or parent) education...

Patient (or parent) education is important to ensure proper medication administration. The patient should lie down with the affected ear facing up. After the canal is filled with drops, the patient should remain in this position for 3 to 5 minutes. Gently massaging the tragus can augment delivery. Patients should keep the ear canal as dry as possible and avoid inserting objects (eg, hearing aids, ear buds, cotton-tipped applicators) into the canal for the duration of treatment. The delivery of topical antibiotics can be enhanced by wick placement. Prescribe analgesics (typically nonsteroidal anti-inflammatory agents) based on severity of pain.⁷

Have patients abstain from water sports for 7 to 10 days. Showering is acceptable with minimal ear exposure to water; bathing is preferred when possible. If there is no clinical improvement in 48 to 72 hours, ask patients to return for re-evaluation.⁸ Prevention is essential for patients with a history of recurrent otitis externa. Acetic acid solutions create an acidic environment within the canal to help prevent recurrent AOE. Ear plugs and petroleum jelly–soaked cotton plugs prior to water exposure may also help prevent recurrent AOE.

Malignant otitis externa

Malignant, or necrotizing, otitis externa is an aggressive disease form of otitis externa that is most common in individuals with diabetes or other immunodeficiency disorders.⁹ Most cases are due to infection with P aeruginosa.¹⁰ Prior to the availability of effective antibiotics, mortality rates in patients with necrotizing otitis externa were as high as 50%.¹¹

What you’ll see. Patients typically present with severe ear pain, otorrhea, conductive hearing loss, and a feeling of fullness in the external ear canal. Physical examination reveals purulent otorrhea and a swollen, tender ear canal. Exposed bone may be visible, most often on the floor of the canal. The tympanic membrane and middle ear are seldom involved on initial presentation.

The infection often originates at the junction of the bony and cartilaginous portion of the external canal, spreading through the fissures of Santorini to the skull base. If not aggressively treated, the infection spreads medially to the tympanomastoid suture causing intracranial complications—usually a facial nerve neuropathy.

Continue to: Given these clinical findings...

Given these clinical findings, promptly order laboratory studies and imaging to confirm the diagnosis. The erythrocyte sedimentation rate and C-reactive protein level are typically elevated, and either can be used as a marker to follow treatment. Computed tomography (CT) helps to determine the location and extent of disease and is recommended as the initial diagnostic imaging modality for patients with suspected malignant otitis externa.¹²

Magnetic resonance imaging helps define soft-tissue changes, dural enhancement, and involvement of medullary bone, making this the preferred modality to monitor therapeutic response.¹² Technetium bone scanning can also be used for the initial diagnosis (particularly if CT findings are normal and clinical suspicion is high) and for follow-up with treatment.

How to treat. Management involves a team approach with otolaryngology, radiology, neurology, endocrinology, and infectious disease specialists. Long term (6-8 weeks) antipseudomonal antibiotic treatment is typical.

In head-to-head laboratory comparisons, distilled water appears to be the best cerumenolytic.

Let culture results guide the choice of antibiotic. Fluoroquinolone therapy, usually ciprofloxacin, is used most often.¹² Surgical intervention may be required for local debridement and drainage of abscesses. Close follow-up is necessary due to reports of recurrence up to 1 year after treatment. If left untreated, necrotizing otitis externa can lead to osteomyelitis, meningitis, septic thrombosis, cerebral abscess, and death.¹¹

Cerumen impaction

The relatively small diameter of the external auditory canal increases the risk for impaction of cerumen and foreign bodies. Cerumen impaction, in particular, is a common primary care complaint. Cerumen forms when glandular secretions from the outer two-thirds of the ear canal mix with exfoliated skin. It functions as a lubricant for the ear canal and as a barrier against infection, water accumulation, and foreign bodies.¹³

Continue to: What you'll see

What you’ll see. You may encounter cerumen impaction in an asymptomatic patient when it prevents visualization of the external auditory canal or tympanic membrane, or when a patient complains of conductive hearing loss, tinnitus, dizziness, ear pain, itching, and cough.¹³ It is found in 1 in 10 children and 1 in 20 adults.¹³ There is a higher incidence in patients who are elderly, are cognitively impaired, or wear hearing devices or ear plugs.^13,14 Asymptomatic cerumen impaction should not be treated. A recent clinical guideline provides a useful “do and don’t” list for patient education (TABLE).¹³

How to treat. In asymptomatic patients, the presence of cerumen on examination is not an indication for removal. Based on current guidelines,¹³ impacted cerumen can safely be removed from the ear canal of symptomatic patients in several ways:

• Manual removal with cerumen loop/spoon or alligator forceps. This method decreases the risk for infection because it limits moisture exposure. However, it should be performed by a health care provider trained in its use because of the risk for trauma to the ear canal and tympanic membrane.
• Irrigation of the ear using tap water or a 50-50 solution of hydrogen peroxide and water. Irrigation can be achieved with a syringe or jet irrigator using a modified tip. This method also has a risk for trauma to the ear canal and tympanic membrane and should only be performed by appropriately trained health care professionals.
• Use of cerumenolytic agents to soften and thin earwax and promote natural extrusion. Several types of cerumenolytic drops (water-based and oil-based) are available and appear to be equally effective. Water-based solutions contain hydrogen peroxide, docusate sodium, acetic acid, and sodium bicarbonate. Oil-based drops may contain peanut, almond, or olive oils. A thorough allergic history should be performed to avoid using products in patients with nut allergies. In head-to-head laboratory comparisons, distilled water appears to be the best cerumenolytic.¹⁵

Foreign bodies

Foreign bodies in the external auditory canal (typically beads, cotton tips, and insects) are more common in children than adults.¹⁶

What you’ll see. Most foreign bodies are lodged in the bony part of the external auditory canal, and many patients try to remove the object before seeking medical care. Removal requires adequate visualization and skill.¹⁷ Although patients may be asymptomatic, most complain of pain, fullness, decreased hearing, or otorrhea.

How to treat. Directly visible objects can often be removed without referral. Suction, irrigation, forceps, probes, and fine hooks have been used. Insect removal can be facilitated by first flooding the canal with xylocaine, alcohol, or mineral oil. Acetone may be used to dissolve foreign bodies containing Styrofoam or to loosen glues. If the object is a button battery, avoid irrigation to prevent liquefaction tissue necrosis.

Continue to: Complications of foreign body removal...

Insect removal can be facilitated by first flooding the canal with xylocaine, alcohol, or mineral oil.

Complications of foreign body removal include pain, otitis externa, otitis media, and trauma to the ear or tympanic membrane. The likelihood of successful removal of the object decreases and the risk for complications increases with each subsequent attempt.¹⁷ Consult an otolaryngologist if sedation or anesthesia is required, the foreign body is tightly wedged, there is trauma to the ear canal or tympanic membrane, the foreign body has a sharp edge (eg, glass or wire), or removal attempts have been unsuccessful.

Trauma

Sports injuries, motor vehicle accidents, bites, falls, and burns are the primary causes of trauma to the external ear.¹⁸

What you’ll see. Blunt auricular trauma predisposes to infection, necrosis, and scar contracture. One of the most common sequelae is cauliflower ear. Trauma is particularly common with contact sports such as boxing, wrestling, or mixed martial arts. The skin of the auricle attaches directly to the perichondrium. Following blunt or shearing trauma to the auricle, hematomas form within the space between the perichondrium and cartilage of the anterior ear.¹⁹Following hematoma formation, the healing process brings chondrocytes and fibroblasts to the subperichondrial space, promoting fibrocartilage formation. Over time (and with repeated injury), this can lead to a chronic, bulbous deformity known as cauliflower ear.

How to treat. Small hematomas can be managed by aspiration, while larger ones generally require open drainage.²⁰ Newer treatments involving pressure dressings and the use of fibrin glue have been proposed.²⁰ Recommend that athletes participating in contact sports wear appropriate protective headgear to prevent auricular hematoma and cauliflower ear.

Neoplasm

Roughly 5% of all skin cancers involve the ear, most frequently the pinna due to chronic sun exposure.²¹ The most frequently occurring malignancy of the external ear is basal cell carcinoma (BCC), which is responsible for 80% of all nonmelanoma skin cancers.²²

Continue to: What you'll see

What you’ll see. BCC of the ear usually involves the preauricular area and the helix. The risk for BCC is related to exposure to ultraviolet radiation. BCC of the ear is more common in men and can be particularly aggressive, highlighting the importance of prevention and prompt recognition. BCC typically presents as a fleshy papule that is often translucent or “pearly’” and has overlying telangiectasia and a “rolled” border. Central ulceration can occur as well.

How to treat. Usual treatment of BCC is surgical excision. Prevention is critical and centers on sun avoidance or the use of appropriate sunscreens.

If the object in the external auditory canal is a button battery, avoid irrigation to prevent liquefaction tissue necrosis.

In addition to BCC, exposure of the external ear to sunlight and ultraviolet radiation predisposes patients to the development of squamous cell carcinoma (SCC) and melanoma. SCC has a variety of presentations including papules, plaques, and nodules. SCC has a higher metastatic potential than does BCC.

Keloid

Keloids are an abnormal healing response to soft-tissue injury: benign fibrocartilaginous growths that extend beyond the original wound.

What you’ll see. Keloids are more common in dark-skinned individuals and tend to result from burns, surgical incisions, infection, trauma, tattooing, injections, piercings, and arthropod bites. In some cases, they arise spontaneously. Keloids are more common in areas of increased skin tension (chest, shoulders, back), but may occur on the ears—most commonly after piercing or trauma. Keloids present clinically as slow-growing rubbery or firm nodules. The diagnosis is typically based on clinical appearance but can be confirmed by histopathology.

Continue to: How to treat

How to treat. Treatments vary and include observation, excision, intralesional injections, cryotherapy, enzyme therapy, silicone gel application, and irradiation.²³ Recurrence is common; no therapy has been proven to be universally superior or preferred.

Congenital malformations

Atresia

Disruption of embryologic development (failed invagination of the external auditory canal) can lead to a stenotic or absent ear canal (aural atresia). Aural atresia is also often associated with fusion of the incus and malleus. This condition occurs predominantly in males. Unilateral atresia is more common than bilateral atresia, and the right ear is more often involved than the left.²⁴

Microtia

Microtia is the incomplete development of the pinna leading to a small or deformed pinna. Microtia can be unilateral or bilateral. As with atresia, microtia more commonly affects males and, if unilateral, the right side is more often affected than the left. Microtia can occur in isolation but is often associated with genetic syndromes such as Treacher Collins syndrome and craniofacial microsomia (Goldenhar syndrome). When microtia is identified (typically at birth or early infancy), audiologic testing and a thorough physical examination for evidence of associated defects should be performed. Consult with an audiologist, clinical geneticist, or pediatric otolaryngologist.

Pre-auricular pits

Pre-auricular pits (sinuses) are tiny indentations anterior to the helix and superior to the tragus. While pre-auricular pits are more common on the right side, they are bilateral in 25% to 50% of cases.²⁵ Pre-auricular pits occur in up to 1% of white children, 5% of black children, and 10% of Asian children.²⁵ Children with this condition should undergo formal audiologic testing as their risk for hearing loss is higher compared with the general population.²⁶

Directly visible foreign objects can often be removed without referral, but the likelihood of success decreases with each subsequent attempt.

The branchio-oto-renal syndrome (associated with pre-auricular pits and hearing loss) also features structural defects of the ear, renal anomalies and/or nasolacrimal duct stenosis or fistulas. If this syndrome is suspected, renal ultrasound imaging is warranted. Other indications for renal ultrasound in patients with a pre-auricular pit are any dysmorphic feature, a family history of deafness, an auricular malformation, or a maternal history of gestational diabetes.²⁷ Pre-auricular pits do not require surgery unless they drain chronically or become recurrently infected. Complete surgical excision is the treatment of choice in these cases.

CORRESPONDENCE 
Mark Stephens, MD, 1850 Park Avenue, State College, PA 16801; mstephens3@pennstatehealth.psu.edu

This year, medical media has been dominated by reporting on the devastating COVID-19 pandemic. Many studies and analyses have shown that staying at home, social distancing, quarantining of close contacts, and wearing face masks and face shields are effective ways of preventing spread.

Although initially there were no known effective treatments for severe COVID-19 infection (other than oxygen and ventilator support), we now know that dexamethasone,¹ remdesivir,² and convalescent plasma³ are effective in lessening the severity of illness and perhaps preventing death. That said, we will continue to struggle with COVID-19 for the foreseeable future.

We must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

But other medical illnesses actually predominate in terms of morbidity and mortality, even during this pandemic. For example, although there has been an average of roughly 5600 COVID-19-related deaths per week for the past 4 months,⁴ there are, on average, more than 54,000 deaths per week in the United States from other causes.⁵ This means that we must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

In that light, JFP continues to publish practical, evidence-based clinical reviews designed to keep family physicians and other primary health care clinicians up to date on a variety of topics. For instance, in this issue of JFP, we have articles on:

• Opioid prescribing. Although opioids have risks, they remain potent medications for relief from acute pain, as well as cancer-related pain and chronic pain not sufficiently treated with other medications. Mahvan et al provide expert advice on maximizing benefit and minimizing the risks of opioid prescribing.
• Secondary ischemic stroke prevention. For patients who have suffered a transient ischemic attack or minor stroke, a mainstay of prevention is antiplatelet therapy. Aspirin alone used to be the treatment of choice, but research has demonstrated the value of adding another antiplatelet agent. Helmer et al’s thorough review reminds us that the antiplatelet drug of choice, in addition to aspirin, is clopidogrel, which should be used only for the first 30 days after the event because of an increased bleeding risk.
• Combatting Clostridioides difficile infection. CDI has been a difficult condition to treat, especially in high-risk patients. Zukauckas et al provide a comprehensive review of diagnosis and management. Vancomycin is now the drug of choice, and fecal transplant is highly effective in preventing recurrent CDI.

This diverse range of timely, practical, evidence-based guidance—in addition to coverage of COVID-19 and other rapidly emerging medical news stories—can all be found on our Web site at www.mdedge.com/familymedicine. We remain committed to supplying you with all of the information you need to provide your patients with the very best care—no matter what brings them in to see you.

This year, medical media has been dominated by reporting on the devastating COVID-19 pandemic. Many studies and analyses have shown that staying at home, social distancing, quarantining of close contacts, and wearing face masks and face shields are effective ways of preventing spread.

Although initially there were no known effective treatments for severe COVID-19 infection (other than oxygen and ventilator support), we now know that dexamethasone,¹ remdesivir,² and convalescent plasma³ are effective in lessening the severity of illness and perhaps preventing death. That said, we will continue to struggle with COVID-19 for the foreseeable future.

We must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

But other medical illnesses actually predominate in terms of morbidity and mortality, even during this pandemic. For example, although there has been an average of roughly 5600 COVID-19-related deaths per week for the past 4 months,⁴ there are, on average, more than 54,000 deaths per week in the United States from other causes.⁵ This means that we must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

In that light, JFP continues to publish practical, evidence-based clinical reviews designed to keep family physicians and other primary health care clinicians up to date on a variety of topics. For instance, in this issue of JFP, we have articles on:

• Opioid prescribing. Although opioids have risks, they remain potent medications for relief from acute pain, as well as cancer-related pain and chronic pain not sufficiently treated with other medications. Mahvan et al provide expert advice on maximizing benefit and minimizing the risks of opioid prescribing.
• Secondary ischemic stroke prevention. For patients who have suffered a transient ischemic attack or minor stroke, a mainstay of prevention is antiplatelet therapy. Aspirin alone used to be the treatment of choice, but research has demonstrated the value of adding another antiplatelet agent. Helmer et al’s thorough review reminds us that the antiplatelet drug of choice, in addition to aspirin, is clopidogrel, which should be used only for the first 30 days after the event because of an increased bleeding risk.
• Combatting Clostridioides difficile infection. CDI has been a difficult condition to treat, especially in high-risk patients. Zukauckas et al provide a comprehensive review of diagnosis and management. Vancomycin is now the drug of choice, and fecal transplant is highly effective in preventing recurrent CDI.

This diverse range of timely, practical, evidence-based guidance—in addition to coverage of COVID-19 and other rapidly emerging medical news stories—can all be found on our Web site at www.mdedge.com/familymedicine. We remain committed to supplying you with all of the information you need to provide your patients with the very best care—no matter what brings them in to see you.

This year, medical media has been dominated by reporting on the devastating COVID-19 pandemic. Many studies and analyses have shown that staying at home, social distancing, quarantining of close contacts, and wearing face masks and face shields are effective ways of preventing spread.

Although initially there were no known effective treatments for severe COVID-19 infection (other than oxygen and ventilator support), we now know that dexamethasone,¹ remdesivir,² and convalescent plasma³ are effective in lessening the severity of illness and perhaps preventing death. That said, we will continue to struggle with COVID-19 for the foreseeable future.

We must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

But other medical illnesses actually predominate in terms of morbidity and mortality, even during this pandemic. For example, although there has been an average of roughly 5600 COVID-19-related deaths per week for the past 4 months,⁴ there are, on average, more than 54,000 deaths per week in the United States from other causes.⁵ This means that we must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

In that light, JFP continues to publish practical, evidence-based clinical reviews designed to keep family physicians and other primary health care clinicians up to date on a variety of topics. For instance, in this issue of JFP, we have articles on:

• Opioid prescribing. Although opioids have risks, they remain potent medications for relief from acute pain, as well as cancer-related pain and chronic pain not sufficiently treated with other medications. Mahvan et al provide expert advice on maximizing benefit and minimizing the risks of opioid prescribing.
• Secondary ischemic stroke prevention. For patients who have suffered a transient ischemic attack or minor stroke, a mainstay of prevention is antiplatelet therapy. Aspirin alone used to be the treatment of choice, but research has demonstrated the value of adding another antiplatelet agent. Helmer et al’s thorough review reminds us that the antiplatelet drug of choice, in addition to aspirin, is clopidogrel, which should be used only for the first 30 days after the event because of an increased bleeding risk.
• Combatting Clostridioides difficile infection. CDI has been a difficult condition to treat, especially in high-risk patients. Zukauckas et al provide a comprehensive review of diagnosis and management. Vancomycin is now the drug of choice, and fecal transplant is highly effective in preventing recurrent CDI.

This diverse range of timely, practical, evidence-based guidance—in addition to coverage of COVID-19 and other rapidly emerging medical news stories—can all be found on our Web site at www.mdedge.com/familymedicine. We remain committed to supplying you with all of the information you need to provide your patients with the very best care—no matter what brings them in to see you.

A 32-year-old woman presented to our clinic with left elbow swelling and pain of 6 days’ duration. She’d had a posterior interosseous nerve (PIN) injection (hydrodissection) at another facility 12 days earlier for refractory intersection syndrome.

During nerve hydrodissection, fluid is injected into the area surrounding the nerve in an effort to displace the muscles, tendons, and fascia and thus reduce friction on the nerve. This treatment, often completed with ultrasound guidance, is utilized by patients who want to obtain pain relief without undergoing surgery for nerve entrapment syndromes.

In this case, a combination of 1 mL (40 mg) of methylprednisolone acetate, 1 mL of lidocaine 2%, and 3 mL of normal saline was injected into the supinator muscle belly (proximal dorsal aspect of the forearm) under ultrasound guidance. Six days later, the patient began to experience elbow pain, redness, and swelling. The symptoms progressed within several hours and became so notable that she sought care at an urgent care facility the next morning. At this facility, she was told she had an infection and was prescribed oral levofloxacin 500 mg/d.

The patient presented to our clinic after 4 days of oral levofloxacin with no improvement of symptoms. She denied chills or fever and described her pain as moderate and radiating to her fingers. There was no history of trauma. The patient reported riding her bike more frequently, which had caused the original forearm pain that warranted the PIN injection. There were no other recent changes to activity. Her medical, social, and surgical histories were otherwise unremarkable.

Her vital signs were normal. Physical exam revealed an erythematous and warm left elbow (FIGURE 1). Her left elbow range of motion (extension and flexion) was mildly decreased due to the pain and swelling.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Aspiration of the patient’s olecranon bursa produced 3 mL of cloudy fluid (FIGURE 2). The patient’s painful, swollen, erythematous, warm elbow, cloudy aspirate, and history of preceding PIN hydrodissection were consistent with a diagnosis of septic olecranon bursitis.

PHOTO COURTESY OF MORTEZA KHODAEE, MD, MPH

When septic bursitis is strongly suspected or confirmed, the patient should be started on an antibiotic regimen that covers S aureus.

Septic bursitis usually is caused by bacteria.^1,2 Bursal infection can result from the spread of infection from nearby tissues or direct inoculation from skin trauma. It can also be iatrogenic and occur among healthy individuals.^2,3 Injection anywhere close to the bursa can inoculate enough bacteria to progress to cellulitis first and then septic bursitis. Inflammatory conditions such as gout and rheumatoid arthritis also can cause acute and/or chronic superficial bursitis.^1,2,4

Differentiating between septic and nonseptic bursitis can be challenging on history and physical exam alone, but specific signs and symptoms should warrant concern for infection.^1,2,4,5 Fever is present in up to 75% of septic cases⁵; however, lack of fever does not rule out septic bursitis. Pain, erythema, warmth, and an overlying skin lesion also can indicate infection.⁴ Diagnostic imaging modalities may help distinguish different types of olecranon bursitis, but in most cases, they are not necessary.²

Other joint disorders factor into the differential

The differential diagnosis is broad and includes a variety of joint disorders in addition to septic (and nonseptic) bursitis.^2,3

Septic arthritis is a deeper infection that involves the elbow joint and is considered an orthopedic emergency due to potential joint destruction.

Continue to: A simple joint effusion

A simple joint effusion also arises from the elbow joint, but this diagnosis becomes less likely when the joint aspirate appears cloudy. A simple joint effusion would not produce bacteria on gram stain and culture.

Crystalline inflammatory arthritis (gout, pseudogout) is due to intra-articular precipitation of crystals (uric acid crystals in gout, calcium pyrophosphate crystals in ­pseudogout).

Hematomas would produce gross blood or clot on joint aspiration.

Cellulitis is an infection of the superficial soft tissue (only) and thus, aspiration is not likely to yield fluid.

Diagnosis can be made with culture of fluid

Confirmation of septic olecranon bursitis is best attained by bursal needle aspiration and culture. Aspiration also can evaluate for other causes of elbow swelling. (If septic olecranon bursitis is suspected clinically, empiric antibiotics should be started while awaiting culture results.⁶) White blood cell counts from the aspirate also may be utilized but have a lower sensitivity and specificity for diagnosis.⁷

Continue to: In addition to aiding in diagnosis

In addition to aiding in diagnosis, bursal aspiration for a patient with septic bursitis can improve symptoms and reduce bacterial load.^1-3,8 The use of a compressive bandage after aspiration may help reduce re-accumulation of the bursal fluid.^1-3,8Staphylococcus aureus is responsible for the majority of septic olecranon bursitis cases.^9-11

Tailoring the antibiotic regimen

There is wide variation in the treatment of septic olecranon bursitis due to the lack of strong evidence-based guidelines.^1,2,8,11-13 When septic bursitis is strongly suspected (or confirmed) the patient should be started on an antibiotic regimen that covers S aureus.^1,2 Once culture results and sensitivities return, the antibiotic regimen can be tailored appropriately.

In cases of mild-to-moderate septic olecranon bursitis in an immunocompetent host, the patient can be started on oral antibiotics and monitored closely as an outpatient.^1-3,8 Patients with septic olecranon bursitis who meet the criteria for systemic inflammatory response syndrome or who are immunocompromised should be hospitalized and started on intravenous antibiotics.^1-3 Recommended duration of antibiotic therapy varies but is usually about 10 to 14 days.^1-3,8 In rare cases, surgical intervention with bursectomy may be necessary.^1,2,14

Our patient was given a dose of ceftriaxone 250 mg intramuscularly and was started on oral sulfamethoxazole/trimethoprim 800 mg/160 mg twice daily after aspiration of the bursa. Culture of the bursal fluid grew oxacillin-sensitive S aureus which was sensitive to a variety of antibiotics including levofloxacin and sulfamethoxazole/trimethoprim. Her symptoms gradually improved (FIGURE 3) and resolved after a 14-day course of oral sulfamethoxazole/trimethoprim.

PHOTO COURTESY OF MORTEZA KHODAEE, MD, MPH

CORRESPONDENCE
Morteza Khodaee, MD, MPH, University of Colorado School of Medicine, Department of Family Medicine & Orthopedics, AFW Clinic, 3055 Roslyn St, Denver, CO 80238; morteza. khodaee@cuanschutz.edu

A 32-year-old woman presented to our clinic with left elbow swelling and pain of 6 days’ duration. She’d had a posterior interosseous nerve (PIN) injection (hydrodissection) at another facility 12 days earlier for refractory intersection syndrome.

During nerve hydrodissection, fluid is injected into the area surrounding the nerve in an effort to displace the muscles, tendons, and fascia and thus reduce friction on the nerve. This treatment, often completed with ultrasound guidance, is utilized by patients who want to obtain pain relief without undergoing surgery for nerve entrapment syndromes.

In this case, a combination of 1 mL (40 mg) of methylprednisolone acetate, 1 mL of lidocaine 2%, and 3 mL of normal saline was injected into the supinator muscle belly (proximal dorsal aspect of the forearm) under ultrasound guidance. Six days later, the patient began to experience elbow pain, redness, and swelling. The symptoms progressed within several hours and became so notable that she sought care at an urgent care facility the next morning. At this facility, she was told she had an infection and was prescribed oral levofloxacin 500 mg/d.

The patient presented to our clinic after 4 days of oral levofloxacin with no improvement of symptoms. She denied chills or fever and described her pain as moderate and radiating to her fingers. There was no history of trauma. The patient reported riding her bike more frequently, which had caused the original forearm pain that warranted the PIN injection. There were no other recent changes to activity. Her medical, social, and surgical histories were otherwise unremarkable.

Her vital signs were normal. Physical exam revealed an erythematous and warm left elbow (FIGURE 1). Her left elbow range of motion (extension and flexion) was mildly decreased due to the pain and swelling.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Aspiration of the patient’s olecranon bursa produced 3 mL of cloudy fluid (FIGURE 2). The patient’s painful, swollen, erythematous, warm elbow, cloudy aspirate, and history of preceding PIN hydrodissection were consistent with a diagnosis of septic olecranon bursitis.

PHOTO COURTESY OF MORTEZA KHODAEE, MD, MPH

When septic bursitis is strongly suspected or confirmed, the patient should be started on an antibiotic regimen that covers S aureus.

Septic bursitis usually is caused by bacteria.^1,2 Bursal infection can result from the spread of infection from nearby tissues or direct inoculation from skin trauma. It can also be iatrogenic and occur among healthy individuals.^2,3 Injection anywhere close to the bursa can inoculate enough bacteria to progress to cellulitis first and then septic bursitis. Inflammatory conditions such as gout and rheumatoid arthritis also can cause acute and/or chronic superficial bursitis.^1,2,4

Differentiating between septic and nonseptic bursitis can be challenging on history and physical exam alone, but specific signs and symptoms should warrant concern for infection.^1,2,4,5 Fever is present in up to 75% of septic cases⁵; however, lack of fever does not rule out septic bursitis. Pain, erythema, warmth, and an overlying skin lesion also can indicate infection.⁴ Diagnostic imaging modalities may help distinguish different types of olecranon bursitis, but in most cases, they are not necessary.²

Other joint disorders factor into the differential

The differential diagnosis is broad and includes a variety of joint disorders in addition to septic (and nonseptic) bursitis.^2,3

Septic arthritis is a deeper infection that involves the elbow joint and is considered an orthopedic emergency due to potential joint destruction.

Continue to: A simple joint effusion

A simple joint effusion also arises from the elbow joint, but this diagnosis becomes less likely when the joint aspirate appears cloudy. A simple joint effusion would not produce bacteria on gram stain and culture.

Crystalline inflammatory arthritis (gout, pseudogout) is due to intra-articular precipitation of crystals (uric acid crystals in gout, calcium pyrophosphate crystals in ­pseudogout).

Hematomas would produce gross blood or clot on joint aspiration.

Cellulitis is an infection of the superficial soft tissue (only) and thus, aspiration is not likely to yield fluid.

Diagnosis can be made with culture of fluid

Confirmation of septic olecranon bursitis is best attained by bursal needle aspiration and culture. Aspiration also can evaluate for other causes of elbow swelling. (If septic olecranon bursitis is suspected clinically, empiric antibiotics should be started while awaiting culture results.⁶) White blood cell counts from the aspirate also may be utilized but have a lower sensitivity and specificity for diagnosis.⁷

Continue to: In addition to aiding in diagnosis

In addition to aiding in diagnosis, bursal aspiration for a patient with septic bursitis can improve symptoms and reduce bacterial load.^1-3,8 The use of a compressive bandage after aspiration may help reduce re-accumulation of the bursal fluid.^1-3,8Staphylococcus aureus is responsible for the majority of septic olecranon bursitis cases.^9-11

Tailoring the antibiotic regimen

There is wide variation in the treatment of septic olecranon bursitis due to the lack of strong evidence-based guidelines.^1,2,8,11-13 When septic bursitis is strongly suspected (or confirmed) the patient should be started on an antibiotic regimen that covers S aureus.^1,2 Once culture results and sensitivities return, the antibiotic regimen can be tailored appropriately.

In cases of mild-to-moderate septic olecranon bursitis in an immunocompetent host, the patient can be started on oral antibiotics and monitored closely as an outpatient.^1-3,8 Patients with septic olecranon bursitis who meet the criteria for systemic inflammatory response syndrome or who are immunocompromised should be hospitalized and started on intravenous antibiotics.^1-3 Recommended duration of antibiotic therapy varies but is usually about 10 to 14 days.^1-3,8 In rare cases, surgical intervention with bursectomy may be necessary.^1,2,14

Our patient was given a dose of ceftriaxone 250 mg intramuscularly and was started on oral sulfamethoxazole/trimethoprim 800 mg/160 mg twice daily after aspiration of the bursa. Culture of the bursal fluid grew oxacillin-sensitive S aureus which was sensitive to a variety of antibiotics including levofloxacin and sulfamethoxazole/trimethoprim. Her symptoms gradually improved (FIGURE 3) and resolved after a 14-day course of oral sulfamethoxazole/trimethoprim.

PHOTO COURTESY OF MORTEZA KHODAEE, MD, MPH

CORRESPONDENCE
Morteza Khodaee, MD, MPH, University of Colorado School of Medicine, Department of Family Medicine & Orthopedics, AFW Clinic, 3055 Roslyn St, Denver, CO 80238; morteza. khodaee@cuanschutz.edu

A 32-year-old woman presented to our clinic with left elbow swelling and pain of 6 days’ duration. She’d had a posterior interosseous nerve (PIN) injection (hydrodissection) at another facility 12 days earlier for refractory intersection syndrome.

During nerve hydrodissection, fluid is injected into the area surrounding the nerve in an effort to displace the muscles, tendons, and fascia and thus reduce friction on the nerve. This treatment, often completed with ultrasound guidance, is utilized by patients who want to obtain pain relief without undergoing surgery for nerve entrapment syndromes.

In this case, a combination of 1 mL (40 mg) of methylprednisolone acetate, 1 mL of lidocaine 2%, and 3 mL of normal saline was injected into the supinator muscle belly (proximal dorsal aspect of the forearm) under ultrasound guidance. Six days later, the patient began to experience elbow pain, redness, and swelling. The symptoms progressed within several hours and became so notable that she sought care at an urgent care facility the next morning. At this facility, she was told she had an infection and was prescribed oral levofloxacin 500 mg/d.

The patient presented to our clinic after 4 days of oral levofloxacin with no improvement of symptoms. She denied chills or fever and described her pain as moderate and radiating to her fingers. There was no history of trauma. The patient reported riding her bike more frequently, which had caused the original forearm pain that warranted the PIN injection. There were no other recent changes to activity. Her medical, social, and surgical histories were otherwise unremarkable.

Her vital signs were normal. Physical exam revealed an erythematous and warm left elbow (FIGURE 1). Her left elbow range of motion (extension and flexion) was mildly decreased due to the pain and swelling.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Aspiration of the patient’s olecranon bursa produced 3 mL of cloudy fluid (FIGURE 2). The patient’s painful, swollen, erythematous, warm elbow, cloudy aspirate, and history of preceding PIN hydrodissection were consistent with a diagnosis of septic olecranon bursitis.

PHOTO COURTESY OF MORTEZA KHODAEE, MD, MPH

When septic bursitis is strongly suspected or confirmed, the patient should be started on an antibiotic regimen that covers S aureus.

Septic bursitis usually is caused by bacteria.^1,2 Bursal infection can result from the spread of infection from nearby tissues or direct inoculation from skin trauma. It can also be iatrogenic and occur among healthy individuals.^2,3 Injection anywhere close to the bursa can inoculate enough bacteria to progress to cellulitis first and then septic bursitis. Inflammatory conditions such as gout and rheumatoid arthritis also can cause acute and/or chronic superficial bursitis.^1,2,4

Differentiating between septic and nonseptic bursitis can be challenging on history and physical exam alone, but specific signs and symptoms should warrant concern for infection.^1,2,4,5 Fever is present in up to 75% of septic cases⁵; however, lack of fever does not rule out septic bursitis. Pain, erythema, warmth, and an overlying skin lesion also can indicate infection.⁴ Diagnostic imaging modalities may help distinguish different types of olecranon bursitis, but in most cases, they are not necessary.²

Other joint disorders factor into the differential

The differential diagnosis is broad and includes a variety of joint disorders in addition to septic (and nonseptic) bursitis.^2,3

Septic arthritis is a deeper infection that involves the elbow joint and is considered an orthopedic emergency due to potential joint destruction.

Continue to: A simple joint effusion

A simple joint effusion also arises from the elbow joint, but this diagnosis becomes less likely when the joint aspirate appears cloudy. A simple joint effusion would not produce bacteria on gram stain and culture.

Crystalline inflammatory arthritis (gout, pseudogout) is due to intra-articular precipitation of crystals (uric acid crystals in gout, calcium pyrophosphate crystals in ­pseudogout).

Hematomas would produce gross blood or clot on joint aspiration.

Cellulitis is an infection of the superficial soft tissue (only) and thus, aspiration is not likely to yield fluid.

Diagnosis can be made with culture of fluid

Confirmation of septic olecranon bursitis is best attained by bursal needle aspiration and culture. Aspiration also can evaluate for other causes of elbow swelling. (If septic olecranon bursitis is suspected clinically, empiric antibiotics should be started while awaiting culture results.⁶) White blood cell counts from the aspirate also may be utilized but have a lower sensitivity and specificity for diagnosis.⁷

Continue to: In addition to aiding in diagnosis

In addition to aiding in diagnosis, bursal aspiration for a patient with septic bursitis can improve symptoms and reduce bacterial load.^1-3,8 The use of a compressive bandage after aspiration may help reduce re-accumulation of the bursal fluid.^1-3,8Staphylococcus aureus is responsible for the majority of septic olecranon bursitis cases.^9-11

Tailoring the antibiotic regimen

There is wide variation in the treatment of septic olecranon bursitis due to the lack of strong evidence-based guidelines.^1,2,8,11-13 When septic bursitis is strongly suspected (or confirmed) the patient should be started on an antibiotic regimen that covers S aureus.^1,2 Once culture results and sensitivities return, the antibiotic regimen can be tailored appropriately.

In cases of mild-to-moderate septic olecranon bursitis in an immunocompetent host, the patient can be started on oral antibiotics and monitored closely as an outpatient.^1-3,8 Patients with septic olecranon bursitis who meet the criteria for systemic inflammatory response syndrome or who are immunocompromised should be hospitalized and started on intravenous antibiotics.^1-3 Recommended duration of antibiotic therapy varies but is usually about 10 to 14 days.^1-3,8 In rare cases, surgical intervention with bursectomy may be necessary.^1,2,14

Our patient was given a dose of ceftriaxone 250 mg intramuscularly and was started on oral sulfamethoxazole/trimethoprim 800 mg/160 mg twice daily after aspiration of the bursa. Culture of the bursal fluid grew oxacillin-sensitive S aureus which was sensitive to a variety of antibiotics including levofloxacin and sulfamethoxazole/trimethoprim. Her symptoms gradually improved (FIGURE 3) and resolved after a 14-day course of oral sulfamethoxazole/trimethoprim.

PHOTO COURTESY OF MORTEZA KHODAEE, MD, MPH

CORRESPONDENCE
Morteza Khodaee, MD, MPH, University of Colorado School of Medicine, Department of Family Medicine & Orthopedics, AFW Clinic, 3055 Roslyn St, Denver, CO 80238; morteza. khodaee@cuanschutz.edu

ILLUSTRATIVE CASE

A 40-year-old woman presents to your office to establish care. During your interview you realize that she has never been screened for cervical cancer. In fact, she has not had a pelvic exam because she is fearful of the procedure. She would like to know if alternatives exist for cervical cancer screening. What can you suggest?

Although deaths from cervical cancer decreased in the United States from 1975 to 2017, demographic and social disparities in the burden of the disease remain.^2,3 Data from 2016 reveal that cervical cancer incidence per 100,000 women is lowest among white (7.5), Asian-Pacific Islander (5.8), and American Indian/Alaska native (5.6) women, and highest among Hispanic (9.8) and black (8.7) women, which could be explained by lower screening rates in these populations.^4,5 The National Cancer Institute’s publication on reducing cancer health disparities states that the most effective way to reduce cervical cancer incidence and mortality is by increasing screening rates among women who have not been screened or who have not been screened regularly.⁶

The US Food and Drug Administration (FDA) approved the first human papillomavirus (HPV) screening test in 2003.⁷ Evidence now suggests that high-risk HPV screening provides greater protection against cervical cancer than screening with cytology alone.⁸ The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) have changed their recommendations to include primary HPV testing as an alternative method to Pap smears for cervical cancer screening.⁹

An advantage of primary HPV screening is that it can be performed on a specimen collected by the patient, which could potentially increase rates of screening and help to decrease demographic and social disparities. A randomized trial of almost 2000 women ages 21 to 65 years that evaluated the acceptability of this method to patients revealed that more than half of women prefer the idea of a self-collected specimen to one that is collected by a clinician because it is more convenient and obviates the need for a pelvic exam.¹⁰

A meta-analysis of 36 studies and more than 150,000 women concluded that when self-collected samples were used with signal-based assays, the tests were not as sensitive or specific as when clinician-collected samples were used.¹¹ However, the meta-analysis also found that some polymerase chain reaction (PCR)-based HPV tests were similarly sensitive for both self- and clinician-collected samples.

STUDY SUMMARY

PCR vs signal amplification HPV tests with collection by patients vs clinicians

This meta-analysis compared the accuracy of high-risk HPV self-screening with clinician collection of samples (56 diagnostic accuracy trials; total N not provided) in identifying cervical intraepithelial neoplasia grade 2 or worse (CIN 2+) with signal amplification and PCR tests evaluated separately.¹ In addition, this review evaluated strategies to screen women who are underscreened or not screened, which was defined as women who were irregularly or never screened, or did not respond to reminder letters about cervical cancer screening (25 randomized controlled trials [RCTs]; total N not provided).

In the diagnostic accuracy studies, patients collected a vaginal sample themselves and then had a sample taken by a clinician. CIN 2+ or 3+ was confirmed by either colposcopy and biopsy performed on all patients or by a positive high-risk HPV test result. Studies were further divided into those using assays based on signal amplification or PCR.

Continue to: In signal amplification assays...

In signal amplification assays, the pooled sensitivity for CIN 2+ was lower in the group with the self-collected samples than in the clinician-collected sample group (77%; 95% confidence interval [CI], 69%-82% vs 93%; 95% CI, 89%-96%). The pooled specificity to exclude CIN 2+ was also lower in the group with the self-collected samples (84%; 95% CI, 77%-88% vs 86%; 95% CI, 81%-90%). In high-risk HPV assays based on PCR, there was no difference in sensitivity (96%) or specificity (79%) between the specimen groups.

This study offers robust evidence that high-risk HPV PCR-based assays using patient-collected specimens are as sensitive at diagnosing CIN 2+ or 3+ as using clinician-collected samples.

With regard to the pooled relative sensitivity and specificity of signal amplification assays, those using self-swab samples were less sensitive and less specific for CIN 2+ (sensitivity ratio = 0.85; 95% CI, 0.80-0.89; specificity ratio = 0.96; 95% CI, 0.93-0.98) and CIN 3+ (sensitivity ratio = 0.86; 95% CI, 0.76-0.98; specificity ratio = 0.97; 95% CI, 0.95-0.99). Using PCR assays, there was no difference between groups in relative sensitivity for the diagnosis of CIN 2+ (sensitivity ratio = 0.99; 95% CI, 0.97-1.02) and CIN 3+ (sensitivity ratio = 0.99; 95% CI, 0.96-1.02). Relative specificity was slightly lower in the self-swab group for CIN 2+ (specificity ratio = 0.98; 95% CI, 0.97-0.99) and CIN 3+ (specificity ratio = 0.98; 95% CI, 0.97-0.99).

The second analysis to evaluate which outreach strategies are effective methods for screening underscreened/unscreened women found that delivering self-sample kits to patients was more effective than the control method, which was sending reminders to women to undergo conventional screening (95% vs 53%; mean difference [MD], 41%; 95% CI, 3%-78%). Similarly, mailing kits to patients compared favorably to the control method (25% vs 12%; MD, 13%; 95% CI, 10%-15%).

WHAT’S NEW

Self-collected specimens can beas reliable as clinician-collected ones

This is the first study to provide robust evidence that high-risk HPV PCR-based assays using patient self-collected specimens are as sensitive at diagnosing CIN 2+ or 3+ as using clinician-collected samples.

CAVEATS

Balancing lower specificity with reaching underscreened populations

Patients with a positive HPV test result require additional testing. The success rates for this follow-up are not known and could be a barrier to accurate diagnoses because of accessibility and patient willingness to follow up with a pelvic exam. In addition, self-collection may be less specific than cytology and could increase colposcopy referrals that lead to negative findings and overtreatment.¹² However, the increased acceptance of this screening method could make it an effective strategy to reach underscreened or reluctant patients.

Continue to: CHALLENGES TO IMPLEMENTATION

Availability of PCR-based HPV assays may be an issue

HPV PCR assays may not be available at all laboratories, but signal amplification HPV tests have been shown to be inferior to PCR assays. Physicians will have to confirm with their laboratories whether PCR-based HPV assays are available.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 40-year-old woman presents to your office to establish care. During your interview you realize that she has never been screened for cervical cancer. In fact, she has not had a pelvic exam because she is fearful of the procedure. She would like to know if alternatives exist for cervical cancer screening. What can you suggest?

Although deaths from cervical cancer decreased in the United States from 1975 to 2017, demographic and social disparities in the burden of the disease remain.^2,3 Data from 2016 reveal that cervical cancer incidence per 100,000 women is lowest among white (7.5), Asian-Pacific Islander (5.8), and American Indian/Alaska native (5.6) women, and highest among Hispanic (9.8) and black (8.7) women, which could be explained by lower screening rates in these populations.^4,5 The National Cancer Institute’s publication on reducing cancer health disparities states that the most effective way to reduce cervical cancer incidence and mortality is by increasing screening rates among women who have not been screened or who have not been screened regularly.⁶

The US Food and Drug Administration (FDA) approved the first human papillomavirus (HPV) screening test in 2003.⁷ Evidence now suggests that high-risk HPV screening provides greater protection against cervical cancer than screening with cytology alone.⁸ The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) have changed their recommendations to include primary HPV testing as an alternative method to Pap smears for cervical cancer screening.⁹

An advantage of primary HPV screening is that it can be performed on a specimen collected by the patient, which could potentially increase rates of screening and help to decrease demographic and social disparities. A randomized trial of almost 2000 women ages 21 to 65 years that evaluated the acceptability of this method to patients revealed that more than half of women prefer the idea of a self-collected specimen to one that is collected by a clinician because it is more convenient and obviates the need for a pelvic exam.¹⁰

A meta-analysis of 36 studies and more than 150,000 women concluded that when self-collected samples were used with signal-based assays, the tests were not as sensitive or specific as when clinician-collected samples were used.¹¹ However, the meta-analysis also found that some polymerase chain reaction (PCR)-based HPV tests were similarly sensitive for both self- and clinician-collected samples.

STUDY SUMMARY

PCR vs signal amplification HPV tests with collection by patients vs clinicians

This meta-analysis compared the accuracy of high-risk HPV self-screening with clinician collection of samples (56 diagnostic accuracy trials; total N not provided) in identifying cervical intraepithelial neoplasia grade 2 or worse (CIN 2+) with signal amplification and PCR tests evaluated separately.¹ In addition, this review evaluated strategies to screen women who are underscreened or not screened, which was defined as women who were irregularly or never screened, or did not respond to reminder letters about cervical cancer screening (25 randomized controlled trials [RCTs]; total N not provided).

In the diagnostic accuracy studies, patients collected a vaginal sample themselves and then had a sample taken by a clinician. CIN 2+ or 3+ was confirmed by either colposcopy and biopsy performed on all patients or by a positive high-risk HPV test result. Studies were further divided into those using assays based on signal amplification or PCR.

Continue to: In signal amplification assays...

In signal amplification assays, the pooled sensitivity for CIN 2+ was lower in the group with the self-collected samples than in the clinician-collected sample group (77%; 95% confidence interval [CI], 69%-82% vs 93%; 95% CI, 89%-96%). The pooled specificity to exclude CIN 2+ was also lower in the group with the self-collected samples (84%; 95% CI, 77%-88% vs 86%; 95% CI, 81%-90%). In high-risk HPV assays based on PCR, there was no difference in sensitivity (96%) or specificity (79%) between the specimen groups.

This study offers robust evidence that high-risk HPV PCR-based assays using patient-collected specimens are as sensitive at diagnosing CIN 2+ or 3+ as using clinician-collected samples.

With regard to the pooled relative sensitivity and specificity of signal amplification assays, those using self-swab samples were less sensitive and less specific for CIN 2+ (sensitivity ratio = 0.85; 95% CI, 0.80-0.89; specificity ratio = 0.96; 95% CI, 0.93-0.98) and CIN 3+ (sensitivity ratio = 0.86; 95% CI, 0.76-0.98; specificity ratio = 0.97; 95% CI, 0.95-0.99). Using PCR assays, there was no difference between groups in relative sensitivity for the diagnosis of CIN 2+ (sensitivity ratio = 0.99; 95% CI, 0.97-1.02) and CIN 3+ (sensitivity ratio = 0.99; 95% CI, 0.96-1.02). Relative specificity was slightly lower in the self-swab group for CIN 2+ (specificity ratio = 0.98; 95% CI, 0.97-0.99) and CIN 3+ (specificity ratio = 0.98; 95% CI, 0.97-0.99).

The second analysis to evaluate which outreach strategies are effective methods for screening underscreened/unscreened women found that delivering self-sample kits to patients was more effective than the control method, which was sending reminders to women to undergo conventional screening (95% vs 53%; mean difference [MD], 41%; 95% CI, 3%-78%). Similarly, mailing kits to patients compared favorably to the control method (25% vs 12%; MD, 13%; 95% CI, 10%-15%).

WHAT’S NEW

Self-collected specimens can beas reliable as clinician-collected ones

This is the first study to provide robust evidence that high-risk HPV PCR-based assays using patient self-collected specimens are as sensitive at diagnosing CIN 2+ or 3+ as using clinician-collected samples.

CAVEATS

Balancing lower specificity with reaching underscreened populations

Patients with a positive HPV test result require additional testing. The success rates for this follow-up are not known and could be a barrier to accurate diagnoses because of accessibility and patient willingness to follow up with a pelvic exam. In addition, self-collection may be less specific than cytology and could increase colposcopy referrals that lead to negative findings and overtreatment.¹² However, the increased acceptance of this screening method could make it an effective strategy to reach underscreened or reluctant patients.

Continue to: CHALLENGES TO IMPLEMENTATION

Availability of PCR-based HPV assays may be an issue

HPV PCR assays may not be available at all laboratories, but signal amplification HPV tests have been shown to be inferior to PCR assays. Physicians will have to confirm with their laboratories whether PCR-based HPV assays are available.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 40-year-old woman presents to your office to establish care. During your interview you realize that she has never been screened for cervical cancer. In fact, she has not had a pelvic exam because she is fearful of the procedure. She would like to know if alternatives exist for cervical cancer screening. What can you suggest?

Although deaths from cervical cancer decreased in the United States from 1975 to 2017, demographic and social disparities in the burden of the disease remain.^2,3 Data from 2016 reveal that cervical cancer incidence per 100,000 women is lowest among white (7.5), Asian-Pacific Islander (5.8), and American Indian/Alaska native (5.6) women, and highest among Hispanic (9.8) and black (8.7) women, which could be explained by lower screening rates in these populations.^4,5 The National Cancer Institute’s publication on reducing cancer health disparities states that the most effective way to reduce cervical cancer incidence and mortality is by increasing screening rates among women who have not been screened or who have not been screened regularly.⁶

The US Food and Drug Administration (FDA) approved the first human papillomavirus (HPV) screening test in 2003.⁷ Evidence now suggests that high-risk HPV screening provides greater protection against cervical cancer than screening with cytology alone.⁸ The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) have changed their recommendations to include primary HPV testing as an alternative method to Pap smears for cervical cancer screening.⁹

An advantage of primary HPV screening is that it can be performed on a specimen collected by the patient, which could potentially increase rates of screening and help to decrease demographic and social disparities. A randomized trial of almost 2000 women ages 21 to 65 years that evaluated the acceptability of this method to patients revealed that more than half of women prefer the idea of a self-collected specimen to one that is collected by a clinician because it is more convenient and obviates the need for a pelvic exam.¹⁰

A meta-analysis of 36 studies and more than 150,000 women concluded that when self-collected samples were used with signal-based assays, the tests were not as sensitive or specific as when clinician-collected samples were used.¹¹ However, the meta-analysis also found that some polymerase chain reaction (PCR)-based HPV tests were similarly sensitive for both self- and clinician-collected samples.

STUDY SUMMARY

PCR vs signal amplification HPV tests with collection by patients vs clinicians

This meta-analysis compared the accuracy of high-risk HPV self-screening with clinician collection of samples (56 diagnostic accuracy trials; total N not provided) in identifying cervical intraepithelial neoplasia grade 2 or worse (CIN 2+) with signal amplification and PCR tests evaluated separately.¹ In addition, this review evaluated strategies to screen women who are underscreened or not screened, which was defined as women who were irregularly or never screened, or did not respond to reminder letters about cervical cancer screening (25 randomized controlled trials [RCTs]; total N not provided).

In the diagnostic accuracy studies, patients collected a vaginal sample themselves and then had a sample taken by a clinician. CIN 2+ or 3+ was confirmed by either colposcopy and biopsy performed on all patients or by a positive high-risk HPV test result. Studies were further divided into those using assays based on signal amplification or PCR.

Continue to: In signal amplification assays...

In signal amplification assays, the pooled sensitivity for CIN 2+ was lower in the group with the self-collected samples than in the clinician-collected sample group (77%; 95% confidence interval [CI], 69%-82% vs 93%; 95% CI, 89%-96%). The pooled specificity to exclude CIN 2+ was also lower in the group with the self-collected samples (84%; 95% CI, 77%-88% vs 86%; 95% CI, 81%-90%). In high-risk HPV assays based on PCR, there was no difference in sensitivity (96%) or specificity (79%) between the specimen groups.

This study offers robust evidence that high-risk HPV PCR-based assays using patient-collected specimens are as sensitive at diagnosing CIN 2+ or 3+ as using clinician-collected samples.

With regard to the pooled relative sensitivity and specificity of signal amplification assays, those using self-swab samples were less sensitive and less specific for CIN 2+ (sensitivity ratio = 0.85; 95% CI, 0.80-0.89; specificity ratio = 0.96; 95% CI, 0.93-0.98) and CIN 3+ (sensitivity ratio = 0.86; 95% CI, 0.76-0.98; specificity ratio = 0.97; 95% CI, 0.95-0.99). Using PCR assays, there was no difference between groups in relative sensitivity for the diagnosis of CIN 2+ (sensitivity ratio = 0.99; 95% CI, 0.97-1.02) and CIN 3+ (sensitivity ratio = 0.99; 95% CI, 0.96-1.02). Relative specificity was slightly lower in the self-swab group for CIN 2+ (specificity ratio = 0.98; 95% CI, 0.97-0.99) and CIN 3+ (specificity ratio = 0.98; 95% CI, 0.97-0.99).

The second analysis to evaluate which outreach strategies are effective methods for screening underscreened/unscreened women found that delivering self-sample kits to patients was more effective than the control method, which was sending reminders to women to undergo conventional screening (95% vs 53%; mean difference [MD], 41%; 95% CI, 3%-78%). Similarly, mailing kits to patients compared favorably to the control method (25% vs 12%; MD, 13%; 95% CI, 10%-15%).

WHAT’S NEW

Self-collected specimens can beas reliable as clinician-collected ones

This is the first study to provide robust evidence that high-risk HPV PCR-based assays using patient self-collected specimens are as sensitive at diagnosing CIN 2+ or 3+ as using clinician-collected samples.

CAVEATS

Balancing lower specificity with reaching underscreened populations

Patients with a positive HPV test result require additional testing. The success rates for this follow-up are not known and could be a barrier to accurate diagnoses because of accessibility and patient willingness to follow up with a pelvic exam. In addition, self-collection may be less specific than cytology and could increase colposcopy referrals that lead to negative findings and overtreatment.¹² However, the increased acceptance of this screening method could make it an effective strategy to reach underscreened or reluctant patients.

Continue to: CHALLENGES TO IMPLEMENTATION

Availability of PCR-based HPV assays may be an issue

HPV PCR assays may not be available at all laboratories, but signal amplification HPV tests have been shown to be inferior to PCR assays. Physicians will have to confirm with their laboratories whether PCR-based HPV assays are available.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.