The Measles Outbreak: CDC Recommendations and ACOG Practice Advisory

SUMMARY:

  • Measles (Rubeola)
    • Caused by an RNA virus with 1 serotype
    • Humans are the only natural hosts of measles virus
    • Average of 10 to 12 days from exposure to the appearance of the first symptom (usually fever)
    • Healthcare providers should report suspected measles cases to their local health department within 24 hours
  • Groups at high risk for severe illness include
    • Infants and children aged <5 years
    • Adults aged >20 years
    • Pregnant women
    • People with compromised immune systems, such as from leukemia and HIV infection

KEY POINTS:

Clinical Features

  • Typical presenting features
    • Prodrome of fever (as high as 105°F) and malaise
    • The 3 ‘C’s: Cough | Coryza (runny nose) Conjunctivitis
  • 2 to 3 days: Pathognomonic enanthema: Koplik spots within 2 to 3 days
    • white spots with red areola on buccal mucosa across from lower molars
Koplik Spots on Buccal Mucosa: Credit CDC
  • 3 to 5 days: Maculopapular rash
    • Appears 14 days after a person is exposed
    • Spreads from the head to the trunk to the lower extremities
    • Patients contagious from 4 days before to 4 days after the rash appears
    • Note: Immunocompromised patients may not develop rash
Measles Rash on Back: Credit CDC

Measles Transmission

  • Individuals are contagious from 4 days before to 4 days after the rash appears
  • Considered an ‘highly contagious virus’ according to CDC
    • “…if one person has it, up to 90% of the people close to that person who are not immune will also become infected”
  • Virus lives in nose and throat mucus of an infected person
  • Spread via
    • Breathing contaminated air: Virus can live in an airspace where the infected person coughed or sneezed for up to 2 hours
    • Touching infected surface: Followed by touching eyes, nose or mouth

Complications

  • Common complications include
    • Bronchopneumonia | Laryngotracheobronchitis | Diarrhea
    • Otitis Media: 1/10 children and may result in permanent hearing loss
  • Severe complications in children requiring hospitalization
    • Acute encephalitis: 1/1,000 children, resulting in permanent brain damage
    • Respiratory and neurologic: 1/1,000 children will die from these complications
    • Subacute sclerosing panencephalitis (SSPE): Rare, fatal degenerative disease of CNS, resulting in deterioration and seizures 7 to 10 years after measles infection

Diagnosis and Testing

  • Clinical suspicion
    • Signs and symptoms detailed above
    • Special concern for those traveling internationally or exposed to someone with a febrile rash illness
  • Laboratory confirmation
    • Essential for all sporadic measles cases and all outbreaks
    • A capture IgM EIA (non-quantitative) that incorporates a recombinant measles nucleocapsid protein as the antigen is used to detect measles IgM
    • A commercial, indirect EIA (non-quantitative) assay is used to detect IgG
    • Viral detection methods: Includes real time RT-PCR to detect measles viral RNA (available at many state public health laboratories and though the APHL/CDC Vaccine Preventable Disease Reference Centers)
    • Detection of measles-specific IgM antibody in serum and measles RNA by RT-PCR in a respiratory specimen are the most common methods for confirming measles infection
    • Obtain both a serum sample and a throat swab (or nasopharyngeal swab) from patients suspected to have measles at first contact
    • Urine samples may also contain virus: If possible collect both respiratory and urine samples
    • Public Health: Molecular analysis (genotyping) can map transmission pathways of measles viruses

Evidence of Immunity

Note: Do not accept verbal reports of immunity

Acceptable presumptive evidence of immunity against measles includes ≥1 of the following

  • Written documentation of adequate vaccination
  • Laboratory evidence of immunity *
  • Laboratory confirmation of measles
  • Birth before 1957

*Note: CDC addresses laboratory evidence of immunity and states the following

*People who have negative or equivocal results for measles IgG should be vaccinated or revaccinated. In some cases it is not possible to vaccinate a patient, and you may need to test them with a second line diagnostic assay to determine whether they are immune to measles. Because the sensitivity and specificity of commercial measles IgG assays vary, state public health departments can provide information on appropriate second line assays.

NOTE FOR HEALTHCARE PERSONNEL (HCP): CDC has interim guidance that states

Consider vaccinating HCP born before 1957 who do not have other evidence of immunity to measles

During a measles outbreak, 2 doses of measles virus-containing vaccine are recommended for all HCP, regardless of year of birth

See more HCP interim guidance using the CDC link below in ‘Learn More – Primary Sources’

Measles Vaccine Recommendations (CDC)

  • Children – MMR vaccine
    • First dose: 12 through 15 months of age
    • Second dose: 4 through 6 years of age no earlier than 28 days following the first dose
  • Students at post-high school educational institutions without evidence of measles immunity
    • 2 doses of MMR vaccine
    • Second dose administered no earlier than 28 days after the first dose
  • Adults born ≥1957 who do not have evidence of measles immunity
    • Should get at least one dose of MMR vaccine
  • International travelers ≥6 months of age
    • Infants 6 through 11 months: one dose of MMR vaccine
      • One dose at 12 through 15 months of age and another dose at 4 through 6 years of age or at least 28 days later
      • Infants who get one dose of MMR vaccine before their first birthday should get two more doses according to the routinely recommended schedule
    • Children ≥12 months: Documentation of two doses of MMR vaccine (the first dose of MMR vaccine should be administered at age 12 months or older; the second dose no earlier than 28 days after the first dose)
    • Teenagers and adults born ≥1957 (no immunity): Documentation of two doses of MMR vaccine, with the second dose administered no earlier than 28 days after the first dose

Post-exposure Prophylaxis

Cannot Readily Show Evidence of Immunity Following Exposure to Measles

  • Offer post-exposure prophylaxis (PEP) or be excluded from the setting (school, hospital, childcare)
  • Unvaccinated individuals who receive their first dose of MMR vaccine within 72 hours after exposure may return to childcare, school, or work except healthcare workers
  • PEP: Administer MMR vaccine within 72 hours of initial measles exposure or immunoglobulin (IG) within six days of exposure
  • Monitor for signs and symptoms consistent with measles for at least one incubation period following PEP
  • Note: “Do not administer MMR vaccine and IG simultaneously, as this practice invalidates the vaccine”

MMR vaccine for PEP

  • Should still offer MMR vaccine even if beyond 72 hours to protect from future exposures
  • Outbreak control measure for infants <12 months of age: Measles vaccination of infants as young as 6 months of age may be used (revaccinate when they are 12 through 15 months old and again when they are 4 through 6 years of age)

Immunoglobulin (IG) for PEP

  • IG dosing
    • IGIM dose: 0.5 mL/kg of body weight (maximum dose = 15 mL)
    • IGIV dose: 400 mg/kg
  • IG used for high risk populations
    • Infants younger <12 months
      • Intramuscular IG (IGIM) for all
      • However, if 6 through 11 months, MMR vaccine can be given in place of IG, if administered within 72 hours of exposure
    • Pregnant women without evidence of measles immunity
      • Intravenous IG (IGIV)
    • Severely compromised immune systems
      • Administer IGIV regardless of immunologic or vaccination status
    • Note: People cannot return to healthcare settings following receipt of IG | For other settings, such as childcare, school, or work “factors such as immune status, intense or prolonged contact, and presence of populations at risk, should be taken into consideration before allowing people to return”
  • PEP for healthcare personnel
    • MMR vaccine should be given within 72 hours or IG should be given within 6 days
    • “Exclude healthcare personnel without evidence of immunity from duty from day 5 after first exposure to day 21 after last exposure, regardless of post-exposure vaccine”

Isolation

  • Isolate for four days after they develop a rash
  • Use airborne precautions in healthcare settings
    • All healthcare staff entering the room should use respiratory protection consistent with airborne infection control precautions (use of an N95 respirator or a respirator with similar effectiveness in preventing airborne transmission)
    • Use single-patient airborne infection isolation room (AIIR) for patient with measles
  • People without evidence of immunity who have been exempted from measles vaccination for medical, religious and now PEP within appropriate timeframe
    • Exclude from affected institutions in the outbreak area until 21 days after the onset of rash in the last case of measles

Treatment

  • There is no specific antiviral therapy for measles
  • Supportive care to address symptoms and complications
  • Severe measles in children: Administer Vitamin A (a substrate for preserving epithelial cell integrity and involved in immune modulation) immediately on diagnosis and repeated the next day with following dosing
    • <6 months: 50,000 IU
    • 6–11 months: 100,000 IU
    • ≥12 months: 200,000 IU

Measles and Pregnancy

  • ACOG has released a practice advisory on measles in pregnancy, and endorses the University of Washington Consensus document (see ‘Learn More – Primary Sources’)
    • Consensus document provides helpful infographics and algorithms
  • ACOG emphasizes that parents will start making decisions about vaccinating their children before or during pregnancy
    • Therefore, obstetric providers can have an impact on decision making by providing facts around importance of MMR
  • Pregnant women are considered a ‘high risk’ category due to increased risk for adverse maternal, fetal and newborn events
    • Maternal: Increased risk of hospitalization and severe respiratory complications including pneumonia
    • Fetal: Miscarriage | Stillbirth | LBW | Preterm birth

Prior to Pregnancy

  • Ensure vaccinations are up to date
  • Wait 4 weeks following MMR to conceive
    • Theoretical risk, not proven and should not be used as an indication for termination of pregnancy (if vaccine received inadvertently)

During Pregnancy

  • Documentation of immunity (see ‘Evidence of Immunity’ section above)
    • Low risk of exposure: Documentation of one dose is adequate
    • Hi risk of exposure: Two doses should be documented
    • Note: ObGyns should contact local heath department officials to confirm correct number of doses
  • If immunity not documented: Consider IgG serologic testing
    • False negatives are possible – ideally send negative result for confirmation to a specialized lab
    • Positive IgG result confirms immunity and no further testing is necessary (University of Washington Consensus Statement)
  • PEP in pregnancy: IGIV within 6 days of measles exposure if
    • Non-immune and exposed (including if serologic testing not readily available)

Postpartum

  • Give MMR postpartum if no evidence of immunity
    • Breastfeeding is safe and does not impact vaccine

Contraindications and Precautions to MMR Vaccine

Contraindication – Greatly Increases Chance of Serious Adverse Reaction

The following individuals should not receive MMR vaccine

  • History of severe allergic reaction (e.g., anaphylaxis) following previous dose or to a vaccine component
  • Known severe immunodeficiency
  • Pregnancy (see above re: theoretical risk)
  • History of anaphylactic reactions to neomycin

Precaution – Might increase the chance or severity of a serious adverse reaction or might compromise the ability of the vaccine to produce immunity

Precautions for MMR vaccine include the following

  • Moderate or severe acute illness with or without fever
  • Recent (within 11 months) receipt of antibody-containing blood product (timing depends on product)
  • History of thrombocytopenia or thrombocytopenic purpura
  • Need for tuberculin skin testing
  • Personal or family history of seizures

Learn More – Primary Sources:

ACOG: Practice Advisory: Management of Pregnant and Reproductive-Aged Women during a Measles Outbreak

CDC: Measles Cases and Outbreaks

CDC: Measles (Rubeola) for Healthcare Professionals  

CDC: About Measles

Measles & the MMR Vaccine: Recommendations Around Pregnancy, Including the Periconception and Postpartum Periods (University of Washington) 

CDC: Routine Measles, Mumps, and Rubella Vaccination

CDC: Interim Infection Prevention and Control Recommendations for Measles in Healthcare Settings

Fetal Alcohol Spectrum Disorders – CDC Summary and Updates

WHAT IS IT?

The current understanding of Fetal Alcohol Spectrum Disorder (FASD) is that there is no known safe amount of alcohol during pregnancy or when trying to get pregnant. All types of alcohol are equally harmful, including all wines and beer. Professional colleges recommend screening women in pregnancy. Fetal Alcohol Syndrome (FAS) is on the most severe end of the spectrum.

Fetal Alcohol Syndrome (FAS) – Diagnostic Criteria 

Abnormal facial features (see diagram below)

  • Smooth philtrum (ridge between nose and upper lip)   
  • Thin vermillion (upper lip)  
  • Small palpebral fissures (distance between inner and outer corners of the eyes) giving the eyes a wide-spaced appearance   

Growth problems (prenatal or postnatal) 

  • Height and/or weight ≤10th percentile 

CNS 

  •  Structural  
    • Head circumference ≤10th percentile  
    • Clinically significant brain abnormalities observable through imaging 
  • Neurological deficits unrelated to a postnatal insult or fever 
  • Functional Performance below expectations  
    • Global cognitive or intellectual deficits (Low IQ or developmental delay in younger children) or  
    • Problems in at least 3 of the following areas  
      • Cognitive or developmental deficits or discrepancies | Executive functioning deficits | Motor functioning delays | Attention deficit or hyperactivity | Social skills | Other problems such as sensory / language / memory  

Maternal Alcohol Exposure

  • Helpful if maternal alcohol use can be confirmed during pregnancy
  • Confirmation of maternal alcohol use is not needed if child meets the other, above criteria

Facial Features of FAS (Credit: NIAAA)


Alcohol-Related Neurodevelopmental Disorder (ARND) 

  • CNS, cognitive and behavioral effects without growth restriction and typical facial experience  
    • Intellectual disabilities | Behavior and Learning abnormalities  
    • Difficulties with math, memory, attention, judgment and impulse control 
    • Requires confirmation of prenatal alcohol exposure

Alcohol-Related Birth Defects (ARBD) 

  • Abnormal physical findings only (see more detail below in ‘Key Points’)  
    • Heart | Kidneys | Bones | Hearing  
    • Requires confirmation of prenatal alcohol exposure

Neurobehavioral Disorder Associated with Prenatal Alcohol Exposure (ND-PAE) 

  • ND-PAE was first included as a recognized condition in the Diagnostic and Statistical Manual 5 (DSM 5) of the American Psychiatric Association (APA) in 2013 
  • Problems identified  
    • Thinking and memory, where the child may have trouble planning or may forget material he or she has already learned 
    • Behavior problems, such as severe tantrums, mood issues (for example, irritability), and difficulty shifting attention from one task to another 
    • Trouble with day-to-day living, which can include problems with bathing, dressing for the weather, and playing with other children.  
  • Diagnosis requires  
    • >13 alcoholic drinks per month (30-day period) of pregnancy or 
    • > 2 alcoholic drinks in one sitting 

KEY POINTS:

  • Structural abnormalities associated with prenatal alcohol exposure include 
    • Facial abnormalities (described above plus short nose, cleft lip/palate)  
    • Cardiac anomalies (ASD, VSD, abnormal great vessels)  
    • Auditory (Chronic serous otitis media, conductive and/or neurosensory hearing loss) 
    • Renal anomalies (Aplastic/dysplastic/hypoplastic kidneys, horseshoe kidney, hydronephrosis, ureteral duplications) 
    • Microcephaly 
    • Meningomyelocele 
    • Hydrocephalus 
    • Short or webbed neck 
    • Vertebra and rib anomalies

Screening Tool  

T-ACE & TACER-3 (same questions with different cut-offs)

  • Tolerance: How many drinks does it take to make you feel high?  
    • Positive answer: ≥ 2 drinks  
      • One drink is the equivalent of 0.5 oz of absolute alcohol (approximately 12 oz of regular beer, 1.5 oz of liquor, or 4 oz of wine) 
    • Score: 2   
  • Annoyance:  Has anybody ever annoyed you by complaining about your drinking?  
    • Positive answer: Yes 
    • Score: 1  
  • Cut down:  Have you ever felt you ought to cut down on your drinking?  
    • Positive answer: Yes 
    • Score: 1  
  • Eye-opener:  Have you ever needed a drink first thing in the morning to get going? 
    • Positive answer: Yes  
    • Score: 1  

Note: T-ACE cut-off is 2; TACER-3 cut-off is 3, which results in fewer false positives

Learn More – Primary Sources:

CDC Fetal Alcohol Spectrum Disorders (FASD) – Basics

CDC: Fetal Alcohol Spectrum Disorders (FASD) – Training And Resources

Note: Includes guidelines and information for nurses, social workers, Family Medicine, ObGyns, Pediatricians and Medical Assistants

AAFP: Fetal Alcohol Syndrome and Fetal Alcohol Spectrum Disorders

ACOG: Fetal Alcohol Spectrum Disorders (FASD) Prevention Program 

Increased cut-point of the TACER-3 screen reduces false positives without losing sensitivity in predicting risk alcohol drinking in pregnancy 

Shingles Vaccine: CDC/ACIP Recommendations 

SUMMARY:  

In October 2017, the FDA approved and ACIP recommended a Shingrix (RZV) vaccine for adults ≥50 years of age. Zostavax (ZVL) is no longer available for use in the United States, as of November 18, 2020.

Herpes Zoster and Postherpetic Neuralgia 

  • Herpes zoster is a localized, painful, cutaneous eruption resulting from reactivation of latent varicella zoster virus (VZV) 
  • Approximately one million cases occur each year in the United States  
  • Incidence increases with age 
    • 50 to 59 years of age: 5 cases per 1,000  
    • ≥80 years: 11 cases per 1,000  
  • Postherpetic Neuralgia is the most common complication  
    • Defined as persistent pain for at least 90 days following the resolution of the herpes zoster rash 
    • Occurs in 10 to 13% of herpes zoster cases in persons aged >50 years and risk increases with age 

Herpes Zoster Vaccine Recommendations  

Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults aged ≥50 years 

  • Two doses of Shingrix provides strong protection against shingles and postherpetic neuralgia (PHN), the most common complication of shingles
    • Shingles Prevention: In adults 50 to 69 years old who got two doses, Shingrix was 97% effective; among adults 70 years and older, Shingrix was 91% effective
    • Postherpetic Neuralgia: In adults 50 to 69 years old who got two doses, Shingrix was 91% effective; among adults 70 years and older, Shingrix was 89% effective
  • Shingrix protection remained high (more than 85%) in people 70 years and older throughout the four years following vaccination
  • Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received Zostavax or have already had herpes zoster
  • There is no maximum age for Shingrix

Clinical Guidance 

  • Administer 2 doses (0.5 mL each) administered intramuscularly 2 to 6 months apart 
  • Shingrix may be used in adults aged ≥50 years, irrespective of prior receipt of varicella vaccine or Zostavax 
  • If patient previously received Zostavax
    • Consider the patient’s age and when he or she received Zostavax to determine when to vaccinate with Shingrix | Differences in efficacy between Shingrix and Zostavax are most pronounced among older patients
    • Studies examined the safety of Shingrix vaccination five or more years after Zostavax vaccination | Shorter intervals were not studied, but there are no theoretical or data concerns to indicate that Shingrix would be less safe or effective if administered less than five years after a patient received Zostavax
  • Screening for a history of chickenpox (varicella) not required  
    • Recombinant and adjuvanted vaccines, such as Shingrix, can be administered concomitantly at the same visit, at different anatomic sites, with other adult vaccines (e.g., influenza and pneumococcal vaccines) 
  • Shingrix is not a treatment for herpes zoster or postherpetic neuralgia  
  • Pregnancy and breastfeeding 
    • There are no available data to establish whether Shingrix is safe in pregnant or lactating women   
    • Consider delaying vaccination with Shingrix in such circumstance 

KEY POINTS:  

Counseling and Adverse Events  

  • Reactions to the first dose of Shingrix did not strongly predict reactions to the second dose 
  • Vaccine recipients should be encouraged to complete the series even if they experienced a grade 1 to 3 reaction to the first dose of Shingrix  
    • In studies, Grade 3 solicited symptoms were defined as “preventing normal everyday activity” (pain, headache, fatigue, gastrointestinal symptoms, myalgia, shivering) | surface diameter >100 mm (redness/swelling) | tympanic/oral/axillary temperature >39.0 °C (fever)  
    • Grade 3 unsolicited adverse events were also defined as “preventing normal, everyday activities” 

Adverse Events

  • The impact of prophylactic analgesics in conjunction with Shingrix has not been studied 
  • Adverse local events are relatively common and include 
    • Pain  
    • Redness  
    • Swelling  
  • General adverse reactions include  
    • Myalgia  
    • Fatigue  
    • Headache  
    • Shivering  
    • Fever  
    • Gastrointestinal symptoms
  • Severe (rare) events include
    •  Difficulty breathing
    • Wheezing
    • Hives
    • Pale skin
    • Fast heartbeat
    • Dizziness 
  • Contraindications 
    • History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine OR after previous dose  
    • Acute episode of herpes zoster | Wait until acute episode has abated 

Special Populations 

  • Persons with a history of herpes zoster 
    • Adults with a history of herpes zoster should receive Shingrix as herpes zoster can recur  
  • Persons with chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, and chronic pulmonary disease) 
    • Shingrix should be used 
  • Immunocompromised persons  
    • Shingrix may be used in persons taking low-dose immunosuppressive therapy (e.g., <20 mg/day of prednisone or equivalent or using inhaled or topical steroids), persons anticipating immunosuppression or who have recovered from an immunocompromising illness
    • Advisory Committee on Immunization Practices recommended 2 RZV doses for prevention of herpes zoster and related complications in immunodeficient or immunosuppressed adults aged ≥19 years
    • Second RZV dose should be given 2 to 6 months after the first | For persons who are or will be immunodeficient or immunosuppressed and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first
  • Persons known to be VZV negative 
    • Screening for a history of varicella (either verbally or via laboratory serology) is not recommended 
    • However, in persons known to be VZV negative via serologic testing, ACIP guidelines for varicella vaccination should be followed 
      • All healthy adults should be assessed for varicella immunity, and those who do not have evidence of immunity should receive 2 doses of single-antigen varicella vaccine 4-8 weeks apart 
      • Shingrix has not been evaluated in persons who are VZV seronegative and the vaccine is not indicated for the prevention of chickenpox (varicella) 

Learn More – Primary Sources:

CDC MMWR: Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022 | MMWR (cdc.gov)

CDC: Shingles (Herpes Zoster) Vaccination Information for Healthcare Providers

FDA: SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted)  

CDC Epidemiology and Prevention of Vaccine-Preventable Diseases; The Pink Book: Course Textbook – 13th Edition (2015)

Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study 

Cascade Testing: Notifying and Counseling Relatives of Individuals who are BRCA Mutation Carriers

CLINICAL ACTIONS:

Cascade testing is the process of identifying blood relatives of an individual with a potentially disease-causing mutation in genes such as BRCA1 or BRCA2 (see ‘Related ObG Topics’ below for summaries). Relatives may have inherited the same mutation and may also be at risk. Cascade testing is an efficient way of finding individuals who would benefit from counseling and genetic testing, if they so choose.  If you have a patient who has received a report indicating that they are a carrier of a such a pathogenic variant, consider the following

  • Ensure the patient herself has obtained appropriate care and counseling
    • ACOG recommends that if a provider does not have the necessary genetic expertise, a referral should be made to genetic services and possibly medical and/or gynecologic oncologists
  • Any outreach to relatives of a patient should not come directly from the healthcare team without patient permission
    • Direct communication of your patient’s health information to a relative without permission may be in violation of HIPAA and/or state laws (see ‘Related ObG Topics’ below for more information)
  • Patients should be made aware that their findings may have significant consequences for other family members
    • ACOG states that tested patients “should be informed that they have a duty to notify relatives of the familial risk”
  • Be aware of potential barriers to family outreach by the patient including
    • The patient may be still be processing and making her own personal choices
    • There may be important family dynamics that need to be taken in to account
    • There may be logistical challenges such as knowing the location of family members
    • Financial concerns may delay or obstruct communication between patient and family due to worries regarding test reimbursement and medical costs

SYNOPSIS:

When someone has been identified as a carrier for a pathogenic mutation, there may be serious ramifications for blood relatives. Cascade testing has been shown to be a cost-effective and efficient way to identify other family members who may be at risk and make them aware of lifesaving options. HBOC and Lynch syndrome have been identified by the CDC as high priority syndromes for cascade testing.  There are other genetic syndromes such as Familial Hypercholesterolemia where interventions can be lifesaving and cascade testing may be helpful to family members.

KEY POINTS:

Provide Support and Resources

  • Ensure patients have direct lines of communication to genetic counseling services if relatives, following notification, do want more information
  • Be aware of any ongoing state and professional programs that provide educational resources regarding genetic disorders, especially heritable cancer syndromes
  • ACOG provides a template for a letter that a provider can use to reach out to a family member following patient discussion/approval (see ACOG Committee Opinion in ‘Learn More – Primary Sources’ below)
  • Key highlights of relative communication include the following
    • Inform the family member as to the gene involved and the potential disorder
    • Explain that having a mutation does not necessarily always result in disease but it does mean that an individual who carries this variant is at higher risk
      • If providing overall lifetime risks for carriers, clarify that these are population based numbers and genetic counseling is required to personalize these risk figures
    • Apprise the family member that she may be a risk of having inherited this pathogenic mutation as well
      • In the case of autosomal dominant heritable cancer syndromes, that risk will be 50%
    • Clarify that aside from yourself, there are options including speaking to their own personal physician, a genetic counselor or other providers who may be of assistance
      • Good care requires a multi-disciplinary approach
    • Be prepared to share information about potential costs involved in genetic testing

Learn More – Primary Sources:

ACOG Committee Opinion 727: Cascade Testing: Testing Women for Known Hereditary Genetic Mutations Associated With Cancer

ACOG & SMFM Guidance on the Use of IUDs and Contraceptive Implants

SUMMARY:  

IUDs and etonogestrel single-rod contraceptive implants are categorized as Long-Acting Reversible Contraception (LARC).  ACOG and other professional and public health entities are calling for reduced barriers and improved access to LARC.  The latest ACOG practice bulletin reviews various LARC options, including clinical considerations such as use in the postpartum period and management in the setting of pelvic infections.  ACOG has also released an updated ‘Quick Coding Guide’ for LARC that can be found in ‘Learn More – Primary Sources’ section.

Available LARCs

Copper Intrauterine Device (T380A) 

  • FDA approval for 10 years  

Levonorgestrel-Releasing Intrauterine Devices (LNG-IUD) 

  • Total of 52 mg of levonorgestrel 
    • 20 micrograms released per day (Mirena) 
      • FDA approved for 7 years 
    • 18.6 micrograms released per day (Liletta)  
      • FDA approved for 6 years  
  • Total of 19.5 mg of levonorgestrel (Kyleena) 
    • 17.5 micrograms released per day  
      • FDA approved for 5 years 
  • Total of 13.5 mg of levonorgestrel (Skyla)   
    • 14 micrograms released per day
    • FDA approved for 3 years 

Contraceptive Implant

  • Subdermal implant with a core containing 68 mg of etonogestrel 
  • FDA approved for 3 years

Clinical Considerations

Nulliparous and Adolescents

  • LARCs should be offered routinely as safe and effective contraceptive options for nulliparous women and adolescents
  • Use of LARCs in adolescents supported by the AAP  
  • IUD  
    • MEC category 2 (advantages outweigh risks)
    • Risk of infection is low 
      • No evidence of association with infertility or tubal occlusion   
    • High satisfaction rate based on continuation rates  
    • Expulsion rates may be higher in adolescents vs older women and multiparous vs nulliparous  
    • Like the general population, nulliparous women and adolescents prefer LNG-IUD  
  • Implant 
    • MEC category 1 (no restrictions)  
    • Continuation rates higher in adolescents compared to OCPs  

SMFM Guidance on Women at High Risk for Medical Complications (2019)

  • Use of LARC is encouraged for women at highest risk for adverse health events as a result of a future pregnancy (GRADE 1B)
  • SMFM recommends discussion take place in the prenatal period regarding availability of immediate postpartum LARC and MEC guidelines should be used to determine best method for particular medical conditions (GRADE 1C)
  • Counseling should include discussion around expulsion rates but appear to be outweighed by benefit of higher continuation rates (GRADE 1C)
  • Providers who intend to utilize immediate postpartum LARC should obtain appropriate training (Best Practice)
  • SMFM recommends that for women who are eligible and desire LARC, following a high-risk pregnancy, immediate postpartum LARC should be used vs delayed placement due to overall superior efficacy and cost-effectiveness (GRADE 1B)
  • Encourage breastfeeding following immediate postpartum LARC based on current evidence (GRADE 1B)
  • SMFM suggests that if a women wishes and is eligible for LARC, but immediate postpartum is not feasible, consider early postpartum placement (GRADE 2C)
  • Contraceptive counseling should be (Best Practice)
    • Patient-centered
    • Within a shared decision-making framework 

Timing of Insertion  

  • Interval insertion 
    • Insertion may be performed at any time during menstrual cycle if patient is not pregnant  
    • No benefit to inserting during menses 
  •  Postabortion LARC Insertion  
    • Routinely offer immediate insertion following first trimester and second trimester abortion (induced or spontaneous)  
  • Postpartum LARC Insertion 
    • Offer immediate LARC insertion (IUD and implant) prior to hospital discharge 
    • Higher IUD expulsion rates (10-27%), but cost-benefit supports immediate insertion  
      • Considered ACOG ‘best practice’  
      • Waiting 4-6 weeks may result in barrier to access  
    • Contraindications to IUD placement include chorioamnionitis, endometritis, or puerperal sepsis or ongoing postpartum hemorrhage 

Effect on Breastfeeding  

  • Copper IUD: No hormonal concerns  
  • LNG-IUD and implant: Studies do not demonstrate a deleterious effect on breast feeding including milk volume/composition, newborn weight or exclusive breastfeeding rates  
  • ACOG recommends shared decision making regarding concerns  
    • Patients should be counseled regarding
      • Theoretical risk of reduced duration of breastfeeding
      • Lack of data supporting a negative association

Infection Risk and IUD  

  • Asymptomatic women who are at low risk of STDs and have undergone routine screening  
    • No additional screening required at the time of IUD insertion  
  • Women who have not been screened for STDs or at increased risk for STDs  
    • Requires CDC-recommended STD screening at the time of a single visit for IUD insertion 
    • Do not delay IUD placement while waiting on results  
    • Treat a positive test without removing the IUD  
  • Purulent cervicitis is a contraindication to IUD placement
  • If known chlamydia or gonorrhea infection, delay IUD insertion following infection treatment until  
    • Antibiotic course is complete 
    • Symptoms resolved 
    • Pelvic/cervical exam normal 
    • Repeat testing at 3 months for gonorrhea or chlamydia to rule out reinfection  
  • Routine antibiotic prophylaxis is not recommended prior to IUD insertion 
  • Actinomyces on cytology is an incidental finding 
    • No treatment or IUD removal required if patient is asymptomatic  

Pregnancy with IUD in situ 

  • Determine location of pregnancy to rule out ectopic pregnancy  
  • Remove IUD if strings visible as benefits outweigh risks  
  • If patient opts to retain IUD, counsel regarding risks (which are not totally eliminated by IUD removal) 
    • Abruption, placenta previa, preterm delivery, cesarean delivery, low-birth-weight infants, and chorioamnionitis  
    • Theoretical concerns regarding hormonal exposure with LNG-IUD  
  • If a patient opts for termination, remove at that time  

Ectopic pregnancy and IUDs 

  • IUDs do not increase the risk and therefore can be offered to women with history of ectopic pregnancy 
  • If pregnancy does occur with IUD in place, there is a small increased risk of ectopic pregnancy  

IUD Removal and Menopause 

  • Copper IUD: Wait for a year of amenorrhea before removal  
  • LNG-IUD: Continue until 50-55 years of age  (as amenorrhea may be related to LNG component)
    • Non-contraceptive benefit of protecting uterus in women using estrogen therapy 
  • IUDs do not need to be removed in menopausal women prior to expiration date 

Gyn Procedures with IUD in Place 

  • Endometrial biopsy, colposcopy, cervical ablation or excision, and endocervical sampling may all be performed with an IUD in place 

Backup Contraceptive Method  

  • Copper IUD 
    • No backup method required  
  • LNG-IUD & implant  
    • Backup required (e.g. condoms) for 7 days after insertion unless 
      • Immediately following surgical abortion  
      • 21 days from childbirth 
      • Transition from other reliable method 
      • Within 7 days of LMP for LNG-IUD 
      • Within 5 days of LMP for implant   

KEY POINTS:  

Underlying Mechanism

  • LARC devices do not disrupt pregnancy but rather disrupt fertilization  
  • Copper IUD 
    • Inhibits sperm migration/viability  
  • LNG-IUD 
    • Increased cervical mucus viscosity that prevents sperm entry  
  • Implant  
    • Suppresses ovulation 
    • Increased cervical mucus thickening  
    • Alters endometrial lining  

Adverse Events and Side Effects

IUDs 

  • Overall complications are uncommon and include expulsion (2 to 10%), method failure and rarely perforation (see ‘Related ObG Topics’ below)  
  • Copper IUDs 
    • Heavy Menses and pain  
      • LNG-IUD offers benefit of reduced menses, despite continued ovulation in majority of women  
  • LNG-IUD  
    • Minimal hormone released systemically 
    • Hormone related effects include headaches, nausea, breast tenderness, mood changes, acne and ovarian cyst formation  
    • No difference in weight gain compared to copper IUD  

Implants 

  • Amenorrhea or menstrual irregularity 
  • GI symptoms 
  • Hormonal effects: Headaches, breast pain and worsening acne (10-14%)  
  • Weight gain (reported in 12% of users) 
    • Literature shows no difference in weight gain at 1 year, after adjusting for confounders, between implant and IUD users 
  • Complications related to insertion (1%)  
    • Pain, bleeding, hematoma or incorrect insertion 
  • Complications related to removal (1.7%)  
    • Breakage or inability to palpate/locate the implant because of overly deep insertion 
    • Imaging techniques to identify location include high-frequency ultrasonography, MRI, X-ray, CT, or fluoroscopy 

Failure Rates (typical use)

  • Copper IUD  
    • 0.8 % (1 year)  
    • 10-year failure rate comparable with that of female sterilization (1.9 per 100 women) 
  • LNG-IUD  
    • 20 microgram release:  0.2% (1 year) 
  • Implant 
    • 0.05% (1 year)

Learn More – Primary Sources:

ACOG Practice Bulletin 186: Long-Acting Reversible Contraception: Implants and Intrauterine Devices

SMFM Consult Series #48: Immediate postpartum long-acting reversible contraception for women at high-risk for medical complications

ACOG: Coding for the Contraceptive Implant and IUDs

How Long to Maintain Medical Records?

Providers keep medical charts for the purpose of providing good care, retaining accurate notes and, when necessary, sharing valuable information with colleagues.  Even after a patient has left care, it is not unusual to receive a request for records.  Patients may move or there may be important medical history that can help diagnose another family member at some point in the future (e.g., heritable cancer syndromes).  Additionally, a well-documented medical record is always the best defense against a medical malpractice lawsuit.  As courtroom adage goes, if it isn’t documented, it didn’t happen.

Notes made in the medical record at or near the time of treatment are regarded as highly reliable evidence. Without medical records, healthcare providers might not be able to show what care was provided and whether it met the standard of care. Simply stating the level of care and treatment rendered without providing documentation will often not succeed in a court of law, thus leaving the provider liable for the patient’s alleged injuries.

State and Federal Laws

State and federal laws regarding mandatory record retention requirements for hospitals or similar facilities differ from the laws for physician practices. The retention period for a minor’s records also varies. This variation exists to allow minors to bring suit for medical malpractice after they reach the age of majority for injuries that occurred when they were under age.

Generally, the Medicare Conditions of Participation (COP) require hospitals to retain records for five years (six years for critical access hospitals).  HIPAA privacy regulations require records to be retained for six years from when the record was created to adhere to the federal statute of limitations for civil penalties for HIPAA violations.  See record retention requirements from the healthit.gov site in ‘Learn More – Primary Sources’ below.

Medical Board and Medical Association Policies and Recommendations

When a direct state or federal law does not specify the retention period for physicians, medical boards may be able to provide policies or recommendations on how long a physician should keep records. For example, the Colorado State Board of Medical Examiners Policy 40-07 requires retaining all patient records for a minimum of 7 years after the last date of treatment, or 7 years after the patient reaches age 18 – whichever occurs later.

Storage and Safety Considerations

With the near mandatory use of electronic medical records, the storage of paper records will slowly be eliminated. However, attendant with the use of EMR comes the ever increasing need to prevent loss of data, or worse, hacking and cyber attacks on the electronic data across all industries.  Antiquated infrastructure and uncorrected network vulnerabilities are frequent causes of successful attacks.

Learn More – Primary Sources

HealthIT.gov: State Medical Record Laws: Minimum Medical Record Retention Periods for Records Held by Medical Doctors and Hospital

County of San Bernardino/California Code

From papyrus to the electronic tablet: a brief history of the clinical medical record with lessons for the digital age

Patient experiences with electronic medical records: Lessons learned

Barriers and Facilitators to Online Portal Use Among Patients and Caregivers in a Safety Net Health Care System: A Qualitative Study

Courtesy Mahdi Weinstock LLP, Toronto CA

Waive the Copay and Wave Hello to Potential Legal Penalties

To help out their patients burdened by healthcare costs, providers may on occasion consider not collecting copayments and deductibles. The patient may claim financial distress. Or the amount may not seem worth pursuing, although $20 or more per patient quickly adds up over the course of a year. Routinely waiving copays, however, makes you vulnerable to charges under the federal False Claims Act, as well as the federal antikickback law and similar state laws. And you risk fines of up to $25,000 and possible exclusion from federal insurance programs for violating the federal antikickback law alone.

Except in limited circumstances, Medicare and Medicaid don’t allow such waivers and demand that providers collect those amounts from patients. Routinely waiving them can be interpreted as program abuse. Why? Because a claim to government programs for patients in which a copayment or deductible was waived is misrepresenting the true charge for service.  And there’s more. Rather than being perceived as the kindhearted person that you are, not collecting these payments can make it appear as if you are trying to attract patients by offering something of value, and consequently generating Medicaid or Medicare payments – a violation of the antikickback law.

If the patient has private insurance, you could be giving the patient’s insurer an opening to escape paying its share of your bill. For example, assume there is a $100 total charge where the patient has an 80/20 plan.  If the provider waives the patient’s obligation to pay 20%, then, again arguably, the commercial plan owes only 80% of $80.

Be especially wary of copays. The rules of managed care are federally mandated and clearly state that the patient cannot see the doctor until they make their copayment. Many providers will recognize this clause in their contracts with insurance companies. Health insurance (including commerical) is also governed by a set of federal laws that fall under ERISA (The Employee Retirement Income Security Act). Commercial insurers can claim that the doctor interfered with their contracts with employers/individuals and some insurance companies have been aggressively fighting back on this front, including using the courts.  Therefore, the safest course is simply to avoid granting copay waivers.  If a patient has a true well-defined financial hardship, document the situation and in isolated, worthy cases, there is the option of reducing a deductible.

Ultimately, regardless of how onerous or convoluted insurance plans are, the responsibility for these payments rests with the patient as conceptually, they have entered into a ‘cost sharing’ arrangement with the company or organization that is providing their healthcare coverage.

RESOURCES:

Failure to collect copayments or deductibles for a specific group of Medicare patients

$5.31 Million Civil Settlement Against Hematology-Oncology Medical Practice For Submitting False Claims To Medicare And Medicaid

AAFP: Anti-kickback & Stark Compliance

IUDs and Implants: How to Manage Potential LARC Complications

Use of long-acting reversible contraceptive (LARC) methods, both intrauterine devices and subdermal contraceptive implants, has increased dramatically in the past ten years.  Although the risk of complications is low, as use increases the absolute number of complications will increase.

CLINICAL ACTIONS:

Intrauterine device:

  • Pain
    • Lidocaine paracervical block reduces pain scores on insertion
    • Misoprostol does not improve pain scores and may be associated with nausea and vomiting
  • Strings not visualized
    • Rule out pregnancy and expulsion
    • Recommend backup contraception until IUD position can be verified
    • Recommend emergency oral contraceptives (if appropriate)
    • Ultrasound and X-ray of abdomen and pelvis can be used for localization
  • Possible expulsion
    • IUDs seen in the cervix are partially expelled and should be removed
      • Replacement or use of another method are both acceptable options
    • Low-lying IUDs (lower uterine segment) can be expectantly managed
  • Risk factors for expulsion include
    • Young age
    • Heavy menstrual bleeding and dysmenorrhea
    • Placement postpartum or post second trimester abortion
    • Presence of anatomic distortion of the uterine cavity
  • Uterine perforation
    • Is rare and generally asymptomatic
    • Usually occurs at the time of insertion
      • Do not use misoprostol routinely prior to insertion in nulliparous women but may be considered with difficult insertions
    • Rule out pregnancy and remove surgically unless the surgical risks of removal outweigh the benefits
  • PID
    • Can be treated with the IUD left in situ
    • Consider removal if no clinical improvement after 48-72 hours of antibiotics
  • Pregnancy with an IUD in place
    • Remove the IUD if the strings are visible or IUD within the cervix
    • IUD can be removed at time of procedure if patient elects termination
    • Evaluate for ectopic pregnancy

Implant:

  • Infection prevention
    • Use antiseptic technique and cover the insertion/removal site
    • Skin flora are the most common cause of infection
    • Remove implant if infection does not resolve
  • Bruising
    • Is common
    • Ice and anti-inflammatory medication can help
  • Nonpalpable implant
    • Locate with high frequency (>/= 10 MHz) ultrasound probe, two dimensional X-ray, or CT scan/fluoroscopy
    • Obtain a serum etonogestrel level if all studies are negative/equivocal
    • Refer to a surgeon with knowledge of the anatomy of the arm if implant is within muscle or neurovascular bundle
  • Pregnancy
    • Is rare
    • Remove the implant if the pregnancy is to be continued
    • Rule out ectopic pregnancy

SYNOPSIS:

LARCs are highly effective contraceptives with a low risk of complications.  Those mentioned above should be discussed with patients as part of informed consent.

KEY POINTS:

  • Recognition and prompt diagnosis/treatment of the untoward outcomes described above are important aspects of care
  • Overall, complication rates are low and LARCs remain a very effective mode of birth control

ICD-10 codes:

  • Z30.49 check/reinsertion/removal of implant
  • Z30.430 insertion of IUD
  • Z30.432 removal of IUD
  • Z30.433 removal and reinsertion of IUD

Learn More – Primary Sources:

ACOG Committee Opinion 672: Clinical challenges of long-acting reversible contraceptive methods

Atypical Hyperplasia of the Breast: Follow up and Management

CLINICAL ACTIONS:

Atypical hyperplasia of the breast is a benign but high-risk condition that can be either ductal (ADH) or lobular (ALH); these occur with equal frequency and together are found in about 10% of breast biopsies. Either entity confers a long-term risk of breast cancer that approaches 30% at 25 years of follow-up.

  • Surgically excise atypical hyperplasia when found on a core-needle biopsy
    • Necessary to avoid missing invasive cancer due to sampling error
    • Upgrading can be ≥15 to 30%
  • Exception: Clinical and radiologic follow-up appropriate when atypical hyperplasia is an incidental finding at the site of a targeted biopsy
  • Current breast cancer risk assessment models perform poorly among women with atypical hyperplasia
    • Atypical hyperplasia associated with a relative risk of 4 for future breast cancer
  • Current NCCN screening recommendations include annual mammography, breast awareness, and  clinical encounter every 6 to 12 months, and in addition
    • Consider tomosynthesis
    • Consider annual MRI to begin at diagnosis
    • Based on emerging evidence, ACOG also recommends consideration of yearly breast MRI for atypical hyperplasia
  • Encourage pharmacologic risk reduction with either a selective estrogen-receptor modulator (SERM) or an aromatase inhibitor (AI) for prevention of breast cancer
  • Counsel about healthy lifestyle including ideal body weight and alcohol reduction
  • Atypical hyperplasia is generally not an indication for surgical risk-reduction / mastectomy

SYNOPSIS:

Atypical hyperplasia of the breast reflects proliferation of dysplastic epithelial cell populations.  It is felt to be a transitional zone between benign and malignant breast disease, containing some but not all features of a cancer. Although statistically the long term risk of breast cancer equals or exceeds that conferred by family history and other risk factors, current guidelines in screening do not reflect this.  Similarly, pharmacologic risk reduction strategies have been adopted by <1% of women who could potentially benefit from them.

KEY POINTS:

  • Atypical lobular hyperplasia is histologically similar to lobular carcinoma in situ, but less extensive
  • Atypical ductal hyperplasia and ductal carcinoma in situ share histologic features
  • Both types of hyperplasia share molecular characteristics and gene expression, indicating possibly a continuum of abnormalities.
  • ICD-10: N60.89

Learn More – Primary Sources:

Atypical Hyperplasia of the Breast—Risk Assessment and Management Options

Understanding the premalignant potential of atypical hyperplasia through its natural history: a longitudinal cohort study

National Comprehensive Cancer Network. Breast cancer screening and diagnosis.

ACOG: Diagnosis and Management of Benign Breast Disorders

Ulcerative Genital Conditions in the HIV-Positive Woman

Genital, anal, or perianal ulcers are generally caused by syphilis or herpes.  Chancroid, lymphogranuloma venereum (LGV), and granuloma inguinale (donovaniasis) are less likely diagnoses; however, all these conditions are associated with increased HIV acquisition and transmission.  Guidelines for screening and treatment differ in some cases from those for the HIV-negative patient.

CLINICAL ACTIONS:

  • Evaluate first for herpes and syphilis first
  • Other causes such as chancroid and lymphogranuloma venereum should then be considered

Herpes Simplex (HSV)
Syphilis
Chancroid
Lymphogranuloma Venereum (LGV)
Granuloma Inguinale (donovaniasis)

Herpes Simplex lesions:

  • Caused by herpes simplex viruses (HSV)
  • Common and may be severe, painful and atypical
  • Offer HSV type-specific serologic testing on initial HIV evaluation for asymptomatic individuals
    • HSV DNA polymerase chain reaction (PCR) and viral culture are preferred methods for diagnosis of mucocutaneous HSV lesions caused by HSV
  • Consider suppression or episodic therapy to decrease clinical manifestations if HSV-2 is detected
    • Does not reduce risk for HIV transmission or HSV-2 transmission to susceptible sex partners
    • Generally higher doses/longer duration of treatment are recommended for HIV-positive women

Daily suppression

  • Acyclovir 400-800 mg BID or TID

or

  • Valacyclovir 500 mg BID

or

  • Famciclovir 500 mg BID

Episodic flares

  • Acyclovir 400 mg TID x 5-10 days

or

  • Valacyclovir 1 g BID x 5-10 days

or

  • Famcycolovir 500 mg BID x 5-10 days

Syphilis:

  • Systemic disease caused by Tremonema Pallidum
  • Primary syphilis is characterized by genital ulcers, though secondary/ tertiary/latent forms are not
  • A presumptive diagnosis of syphilis requires a treponemal test (i.e fluorescent treponemal antibody absorbed tests [FTA-ABS]) plus a nontreponemal test (i.e. Venereal Disease Research Laboratory [VDRL] or Rapid Plasma Reagin [RPR])
  • Screen for syphilis on initial HIV evaluation and annually thereafter
  • Treatment is the same regardless of HIV status
    • Penicillin G IM is the preferred treatment for all stages; the preparation (benzathine, aqueous procaine aqueous crystalline), dosage and length of treatment depend on the stage

Chancroid:

  • Painful, genital ulcers with suppurative lymphadenopathy caused by ducreyi
    • Treatment is the same regardless of HIV status
    • Close follow up is required as treatment failure is increased in the HIV positive

Treatment

  • Azithromycin 1 gm po

or

  • Ceftriaxone 250 mg IM

or

  • Ciprofloxacin 500 mg po BID x 3 days

or

  • Erythromycin 500 mg tid x 7 days

Lymphogranuloma Venereum (LGV)

  • Tender, unilateral groin/femoral lymphadenopathy with a self-limited genital ulcer/papule caused by C. trachomatis serovars L1, L2, or L3
  • Proctitis may occur
  • Diagnose by identifying C. trachomatis from the lesion by culture, direct immunofluorescence or nucleic acid detection
  • Treatment is the same regardless of HIV status

Treatment

  • Doxycycline 100 mg BID x 3 weeks

or

  • Erythromycin base 500 mg QID x 3 weeks

Granuloma Inguinale (Donovanosis):

  • Painless ulcerative disease characterized by beefy red, highly vascular lesions caused by Klebsiella granulomatis
  • Diagnose by identifying dark-staining “Donovan Bodies” on biopsy or tissue
  • Treatment is the same regardless of HIV status

Treatment  

  • Azithromycin 1 gm once/week or 500 mg/day x 3 weeks/until lesions healed

or

  • Doxycycline 100 mg BID X 3 weeks/until lesions healed

or

  • Ciprofloxacin 750 mg BID x 3 weeks/until lesions healed

or

  • Erythromycin base 500 mg QID x 3 weeks/until lesions healed

or

  • Trimethoprim-sulfamethoxazole double strength BID x 3 weeks/until healed

SYNOPSIS:

Vaginal, vulvar, and sexually transmitted infections may increase the risk of HIV transmission.  Prompt diagnosis and treatment decreases the likelihood of transmission; public health standards require providers to presumptively treat any patient, regardless of HIV status, with suspected syphilis immediately and before test results are available.  Presumptive treatment of primary herpes is also recommended as early treatment maximizes success.

KEY POINTS:

  • Genital, anal, or perianal lesions may not necessarily be infectious (e.g. trauma, carcinoma, aphthous, drug eruption, psoriasis)
  • Medical history and physical exam findings are frequently inaccurate and should be followed by tests that reflect conditions prevalent in the area
  • Consider biopsy for ulcers not responding to therapy or if the diagnosis is unclear
  • If HIV status is unknown, HIV testing should be offered to any woman with genital/anal ulcers presenting for treatment.

Diagnosis codes:

  • D28.9 benign neoplasm of female genital organs, unspecified
  • Z21 HIV infection

Learn More – Primary Sources:

2015 Sexually Transmitted Disease Treatment Guidelines

ACOG Practice Bulletin 167: Gynecologic Care for Women and Adolescents with Human Immunodeficiency Virus

NIH Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents

Evaluation of the Adnexal Mass

Masses of the ovary, fallopian tube or other pelvic organs may be incidental findings on examination or may present with symptoms of pain. The diagnostic evaluation determines need for and type of surgical or medical intervention.

CLINICAL ACTIONS:

  • Obtain a medical, gynecologic and family history and review of systems
  • Evaluate vital signs and general appearance
  • Exam should include assessment of cervical, supraclavicular, axillary and groin nodes as well as breast, abdominal and pelvic examination
  • Clinical findings suggestive of malignancy include
    • Irregular contour
    • Firm
    • Fixed
    • Nodular
    • Bilaterality
    • Ascites

Imaging

Ultrasound

  • Obtain transvaginal ultrasound to assess mass for findings suggestive of malignancy including
    • Size and composition of mass
    • Laterality
    • Septations
    • Solid components
    • Excrescences
    • Pelvic free fluid
  • Abdominal ultrasound is a ‘useful addition’ if
    • Anatomic distortion present (e.g., previous surgeries)
    • Mass extending beyond pelvis
    • Transvaginal sono is not possible (e.g., young, virginal or prepubertal)
  • Ultrasound algorithms to predict malignancy (see ‘Related ObG Topics’ below)
    • IOTA group: Simple Rules
    • Other algorithms also available

Other Imaging Modalities

  • CT, MRI and PET are not recommended as ‘first line’ imaging modalities
    • MRI can help differentiate origin of mass when unclear
    • CT scan can be helpful to evaluate abdomen when cancer is suspected
    • MRI and CT may be used to as an adjunct in the work up of suspected cystic teratomas (differentiates lipid densities)

Serum Markers

  • Biomarkers can be used in the evaluation of a pelvic mass but are not currently recommended for use in population based screening for ovarian cancer

CA 125

  • Overall wide range of sensitivity and specificity, especially in premenopausal women
    • PPV: 5% to 91%,
    • NPV: 67% to 90%
  • Postmenopausal
    • PPV of CA 125 is higher in postmenopausal women
    • Elevated CA 125 and pelvic mass in postmenopausal woman warrants referral to Gyn Oncologist
  • Premenopausal
    • Less valuable but extreme values warrant caution and raised suspicion
    • No evidence-based threshold currently exists for premenopause
    • Other causes: Fibroids |  Endometriosis | PID | Ascites (not necessarily related to ovarian cancer) | Medical disorders with inflammatory component

Biomarker Panels

Two FDA approved serum tumor marker panel tests, for use in women >18 years with an already identified adnexal mass that requires surgery

  • Multivariate index assay
    • Combination of CA 125 II | Transferrin | Transthyretin (prealbumin) | Apolipoprotein A-1 | ß 2-microgloblin
    • Translates into a malignancy risk score of 0-10 using proprietary algorithm
    • “…higher sensitivity and negative predictive value for ovarian malignancy when compared with clinical impression and CA 125 alone”
    • Sensitivity increases with additional clinical assessment and inclusion of ultrasound findings
  • Risk of Ovarian Malignancy Algorithm
    • Combination of CA 125 | Human epididymis protein 4 | Menopausal status
    • Algorithm based on variable cut-off values related to menopausal status
    • epididymis protein 4 is more sensitive and specific than CA 125
  • ACOG states

Serum biomarker panels may be used as an alternative to CA 125 level alone in determining the need for referral to or consultation with a gynecologic oncologist when an adnexal mass requires surgery

Other Markers

  • If suspicious for less common tumors (e.g. germ cell), consider
    • ß-hCG | L-LDH | AFP
  • Granulosa cell tumors (solid mass and postmenopausal bleeding)
    • Inhibin | Estrogen

SYNOPSIS:

Evaluation of the patient with an adnexal mass is intended to exclude malignancy, identify patients in need of emergent surgery and allow appropriate scheduling for those who need nonemergent surgery.  Patients with tubo-ovarian abscesses may respond to medical management or interventional radiologic drainage. Those with small cysts can often be followed with ultrasound in anticipation of spontaneous resolution. Metastatic cancers, especially from breast, colon or stomach may present as adnexal masses.  Those with findings suggestive of malignancy should have consultation with or referral to a gynecologic oncologist.

KEY POINTS:

  • Age and a strong family history of breast or ovarian cancer remain important risk factors for ovarian malignancy
  • Transvaginal ultrasonography is the recommended imaging for pelvic masses
    • Findings of concern include: cyst size greater than 10 cm, papillary or solid components, irregular shape, ascites, high color Doppler flow
  • Benign masses will generally show the following on ultrasound
    • Thin, smooth walls, no solid components or septation, no internal blood flow on color Doppler
  • Simple cysts over 10 cm are generally considered an indication for surgery but may resolve over time
  • Serum marker testing in combination with other tests can be used to evaluate likelihood of malignancy

Note: The ESGO/ISUOG/IOTA/ESGE Consensus Statement (see ‘Learn More – Primary Sources’ below) provides excellent summary tables on clinical and ultrasound features of adnexal masses

When to Observe

  • Ultrasound suggests benign disease
  • Ultrasound findings unclear but there is a good reason to try and avoid surgery
  • Normal CA 125 level and no suspicious ultrasound findings
  • <10 cm simple cysts, even in postmenopause can be observed with repeat imaging
  • Benign disease: Endometriomas | Mature teratomas | Hydrosalpinx
  • Repeat ultrasound
    • ACOG states

The ideal interval and duration for ultrasound follow-up has yet to be defined. However, in one study, masses that were monitored and eventually diagnosed as malignancies all demonstrated growth by 7 months . Some experts recommend limiting observation of stable masses without solid components to 1 year, and stable masses with solid components to 2 years.

When to Refer to Gyn Oncology

  • Postmenopausal
    • Elevated CA 125 | Suspicious ultrasound or clinical findings
  • Premenopausal
    • Very elevated CA 125 level | Suspicious ultrasound or clinical findings
  • Premenopausal or postmenopausal
    • Elevated score on a formal biomarker risk assessment test or ultrasound-based scoring systems from the IOTA group

Learn More – Primary Sources:

ACOG Practice Bulletin No. 174: Evaluation and management of adnexal masses

NEJM Case 18-2019: A 24-Year-Old Woman with a Pelvic Mass

ESGO/ISUOG/IOTA/ESGE Consensus Statement on preoperative diagnosis of ovarian tumors