Primary Care Screening: USPSTF Recommendations for Your Patient
Preventive Healthcare Services Recommendations
Courtesy of the US Department of Health and Human Services – AHQR
Enter the following information to obtain screening, counseling and preventive medication recommendations from the USPSTF Preventive Services Database:
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This tool is not meant to replace clinical judgment and individualized patient care.
Screening for Sexually Transmitted Infections – Who, When and How Often?
SYNOPSIS:
There are an estimated 2.8 million new chlamydia infections each year in the US and 1.5 million new cases of gonorrhea diagnosed. The highest rates of both gonorrhea and chlamydia are reported in women aged 15 to 24. Symptoms are vague and sequelae can include pelvic inflammatory disease, ectopic pregnancy and infertility. A full comprehensive sexual history may identify other risk factors to prompt more comprehensive screening for sexually transmitted infections
CLINICAL ACTIONS:
Sexually transmitted infections (STIs) are common with potential for serious long term outcomes, and remain a serious public health concern. Here, we outline the recommendations for screening for STIs by population:
Adults
- Annual screening for gonorrhea and chlamydia is recommended for all sexually active women < 25 years | Evidence is insufficient for routine testing of gonorrhea and chlamydia in heterosexual men | Consider screening young men in high prevalence clinical settings e.g., adolescent clinics, correctional facilities, STI/sexual health clinic
- Re-testing is recommended 3 months after treatment due to high re-infection rates
- Screening is recommended for adults >25 years old at increased risk for infection (new partner, multiple partners, or a partner who has an STI)
- Consider testing for rectal chlamydia and pharyngeal gonorrhea based on sexual history practices
- Annual testing is recommended for men who have sex with men (MSM) at sites of contact (urethra, rectum)and every 3-6 months if at higher risk e.g. MSM on PrEP, HIV infection, or if they or their sex partners have multiple partners
- Transgender and Gender Diverse Persons screening adapted based on anatomy
- Screening for syphilis is based on risk profile, with higher risk including history of incarceration, transactional sex work, geography, or male younger than 29 years old
- Annual screening for sexually active MSM | 3 to 6 months if at increased risk
- Annual screening for syphilis is recommended in transgender and gender diverse persons
- Screening for HIV should be performed in all adults aged 13-64 and who seek evaluation and treatment for STIs | Annual HIV screening is recommended for MSM with more than one sexual partner, with consideration for more frequent 3-6 month intervals for testing
- Consider type-specific HSV serologic testing in patients presenting for an STI evaluation | Note: USPSTF “recommends against routine serologic screening for genital HSV infection in asymptomatic adolescents and adults, including those who are pregnant”
- Consider screening for trichomonas in high-prevalence settings or patients at higher risk for infection (multiple sex partners, transactional sex, drug misuse, or a history of STI or incarceration)
- Adults at increased risk of Hepatitis B should be screened (born in high endemic area, more than one sex partner in the previous 6 months, evaluation or treatment for an STI, past or current injection-drug use, or a partner with Hepatitis B)
- Screening for hepatitis C infection (HCV) should take include all adults over age 18 years except in settings with HCV positivity < 0.1%
- All persons with risk factors (eg., persons with HIV, prior recipients of blood transfusions, persons who ever injected drugs and shared needles, and persons who are born to an HCV-infected mother) should be tested for HCV, with periodic testing while risk factors persist
Persons living with HIV
- At first HIV evaluation and annually afterwards, screen for
- Gonorrhea
- Chlamydia
- Syphilis
- Hepatitis B surface antigen and Hepatitis B immunity
- Hepatitis C screening for all persons with HIV and subsequent annual testing for MSM
- Specifically for women with HIV
- Screen for trichomonas for women at first evaluation and annually afterwards
- Women should be screened within 1 year of sexual activity with testing repeat 6 months later | 3 normal and consecutive pap tests, screening can be spaced out to every 3 years
The USPSTF 2021 update
…recommends screening for chlamydia in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. (B recommendation) …recommends screening for gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men
KEY POINTS:
- Screen sexually active women ≥ 25 for gonorrhea and chlamydia if at increased risk
- More comprehensive screening for STIs include evaluation for trichomonas, syphilis, HIV, Hepatitis B and Hepatitis C
- Increased risk for Hepatitis B includes those born in a region of high endemicity (see map in ‘Learn More – Primary Sources’ below), such as sub-Saharan Africa, East Asia, the Amazon, southern parts of Eastern and Central Europe or US-born persons not vaccinated where prevalence of Hepatitis B virus >8%
- CDC has updated guidelines to recommend universal Hepatitis C screening in all adults (except where prevalence is < 0.1%)
Learn More – Primary Sources:
CDC: Sexually Transmitted Infections Treatment Guidelines 2021
CDC: A Guide to Taking a Sexual History
CDC Recommendations for Hepatitis C Screening Among Adults — United States, 2020
USPSTF: Screening for Hepatitis B Virus Infection in Adolescents and Adults
Map: Prevalence of hepatitis B virus infection
USPSTF: Screening for Chlamydia and Gonorrhea
Patient with Stable CVD: Rivaroxaban, Aspirin or Both to Prevent Recurrent Events?
BACKGROUND AND PURPOSE:
- Aspirin reduces risk of major CV events by 19% and CV death by 9% in those with CVD
- 5 to 10% of patients will still have recurrent CV events
- Eikelboom et al. (NEJM, 2017) assessed whether rivaroxaban, aspirin or both is most effective for secondary cardiovascular event prevention in those with stable atherosclerotic vascular disease
METHODS:
- Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial
- 602 centers in 33 countries
- Double-blind randomized controlled (RCT) trial
- Inclusion criteria: Coronary artery disease, peripheral arterial disease, or both
- Participants were randomly assigned to 1 of 3 cohorts
- Rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily)
- Rivaroxaban (5 mg twice daily)
- Aspirin (100 mg once daily)
- Primary outcome
- Composite of cardiovascular death, stroke, or myocardial infarction
- The study was stopped short at 23 month follow-up, due to superiority of the rivaroxaban and aspirin group
RESULTS:
- Comparing to aspirin-alone group, the rivaroxaban-plus-aspirin group had
- Fewer patients (4.1% vs 5.4%) with adverse cardiovascular events (hazard ratio [HR] 0.76; 95% CI 0.66 to 0.86; P<0.001)
- More major bleeding events occurred (3.1% vs 1.9% HR 1.70; 95% CI 1.40 to 2.05; P<0.001)
- Most major bleeding was into the gastrointestinal tract
- There was no significant difference in intracranial bleeding, fatal bleeding or bleeding into a critical organ
- There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group ([HR] 0.82; 95% CI 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025)
- When comparing rivaroxaban-alone group than in the aspirin-alone group, there was no significant difference in primary outcome but there were more major bleeding events
CONCLUSION:
- Rivaroxaban-plus-aspirin had better cardiovascular outcomes compared to aspirin alone
- Rivaroxaban alone did not impact outcomes and had more major bleeding events than aspirin alone
Learn More – Primary Sources:
Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
FDA Drug Safety Communication: Clarithromycin and Increased Potential Risk of Heart Problems or Death in Patients With Heart Disease
SUMMARY:
FDA released a drug safety advisory and follow-up review, advising caution before prescribing the antibiotic clarithromycin to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later
- A review of the results from the CLARICOR trial, a 10-year follow-up study of patients with stable coronary heart disease from a large clinical trial, observed this serious safety issue
- More deaths were observed in patients who underwent a two-week course of clarithromycin that became apparent after ≥1 year of follow up
- No clear explanation was apparent as to why clarithromycin would lead to more deaths than placebo
- Observational studies have been conflicting
- The FDA
- Has added a new warning about this increased risk of death in patients with heart disease that also advises prescribers to consider using other antibiotics in such patients
- Has added the study results to the clarithromycin drug labels
- Will continue to monitor safety reports in patients taking clarithromycin
- FDA recommends the following
Healthcare professionals should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.
KEY POINTS:
- Clarithromycin is used to treat many types of infections including
- Those affecting the skin, ears, sinuses and lungs
- Helicobacter pylori
- Mycobacterium avium complex (MAC) infection which can be seen in individuals with HIV
- In the CLARICOR study, there was increased all-cause mortality and CVD during 10 year follow up, primarily in patients not on statin at entry
- FDA recommends that patients talk to their provider about benefits and risks of clarithromycin and any alternative treatments
- Patients should
- Be alert to signs or symptoms of stroke or MI
- Should not stop taking medications without medical discussion and oversight
- Adverse events or side effects should be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program
- Online: MedWatch Online Voluntary Reporting Form (fda.gov)
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Learn More – Primary Sources:
COVID-19: Category Definitions, Symptoms and Those at Increased Risk
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date. This summary has been updated with the latest CDC guidelines on when to end quarantine.
SUMMARY:
The novel coronavirus, named SARS-CoV-2, is the pathogen underlying the pandemic (a global outbreak of disease). The disease associated with this virus has been officially named COVID-19. Coronaviruses represent a large family of viruses. They can cause human illness, but many are found in animals and, rarely, animal coronaviruses can evolve and infect people as was the case in previous infectious outbreaks such as MERS and SARS.
COVID-19 Categories (NIH Panel)
- Asymptomatic or pre-symptomatic infection
- Test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test)
- No symptoms that are consistent with COVID-19
- Mild illness
- Have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell)
- No shortness of breath, dyspnea, or abnormal chest imaging
- Moderate illness
- Evidence of lower respiratory disease during clinical assessment or imaging and oxygen saturation (SpO2) ≥94% on room air at sea level
- Severe illness
- SpO2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, a respiratory rate >30 breaths/min, or lung infiltrates >50%
- Critical illness
- Respiratory failure, septic shock, and/or multiple organ dysfunction
Note: SpO2 is a key parameter for defining the illness categories listed above | Pulse oximetry has important limitations (e.g., skin pigmentation, thickness or temperature) | Clinicians who use SpO2 when assessing a patient must be aware of those limitations and conduct the assessment in the context of that patient’s clinical status
Pregnancy: Oxygen supplementation in pregnancy generally used when SpO2 <95% on room air at sea level to accommodate the physiologic needs of mother and fetus
Symptoms
- Incubation period
- Time from exposure to development of symptoms: 2 to 14 days
- Delta variant studies: Mean incubation period of 4.3 days (see ‘Learn More – Primary Sources Below) which was shorter than initial variants (5.0 days)
- Omicron variant studies: Median incubation period of 3 to 4 days
- Time from exposure to development of symptoms: 2 to 14 days
- Signs and Symptoms
- Fever or chills
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- Muscle or body aches
- Headache
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
- Additional points regarding presentation
- Older adults: Especially those with comorbidities may have delayed presentation of fever and respiratory symptoms
- Fatigue, headache, and muscle aches (myalgia) are among the most commonly reported symptoms in people who are not hospitalized
- Sore throat and nasal congestion or runny nose (rhinorrhea) also may be prominent symptoms
- GI symptoms may be relatively common
- Nausea, vomiting or diarrhea may occur prior to fever and lower respiratory tract signs and symptoms
- Loss of smell (anosmia) or taste (ageusia) has been commonly reported, especially among women and younger or middle-aged patients
Those at Risk Based on Evidence (CDC)
- Age
- The CDC states
Age is the strongest risk factor for severe COVID-19 outcomes. Approximately 54.1 million people aged 65 years or older reside in the United States; in 2020 this age group accounted for 81% of U.S. COVID-19 related deaths, and as of September 2021 the mortality rate in this group was more than 80 times the rate of those aged 18-29
Higher Risk: Meta-analysis or systematic review demonstrates good or strong evidence
- Asthma
- Cancer
- Cerebrovascular disease
- Chronic kidney disease*
- Chronic lung diseases limited to
- Interstitial lung disease
- Pulmonary embolism
- Pulmonary hypertension
- Bronchiectasis
- COPD (chronic obstructive pulmonary disease)
- Chronic liver diseases limited to
- Cirrhosis
- Non-alcoholic fatty liver disease
- Alcoholic liver disease
- Autoimmune hepatitis
- Cystic fibrosis
- Diabetes mellitus, type 1 and type 2*‡
- Disabilities‡
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- Cerebral Palsy
- Congenital Malformations (Birth Defects)
- Limitations with self-care or activities of daily living
- Intellectual and Developmental Disabilities
- Learning Disabilities
- Spinal Cord Injuries
- Heart conditions (such as heart failure, coronary artery disease, or cardiomyopathies)
- HIV (human immunodeficiency virus)
- Mental health disorders limited to
- Mood disorders, including depression
- Schizophrenia spectrum disorders
- Neurologic conditions limited to dementia‡
- Obesity (BMI ≥30 kg/m2 or ≥95th percentile in children)*‡
- Primary Immunodeficiencies
- Pregnancy and recent pregnancy
- Physical inactivity
- Smoking, current and former
- Solid organ or hematopoietic cell transplantation
- Tuberculosis
- Use of corticosteroids or other immunosuppressive medications
Suggestive Higher Risk: Underlying medical condition or risk factor that neither has a published meta-analysis or systematic review nor completed the CDC systematic review process
- Children with certain underlying conditions
- Down syndrome
- HIV (human immunodeficiency virus)
- Neurologic conditions, including dementia
- Overweight (BMI ≥25 kg/m2, but <30 kg/m2)
- Sickle cell disease
- Solid organ or blood stem cell transplantation
- Substance use disorders
- Use of corticosteroids or other immunosuppressive medications
Comorbidities with mostly case series, case reports, or, if other study design, the sample size is small
- Overweight (BMI ≥25 kg/m2, but <30 kg/m2)
- Sickle cell disease
- Substance use disorders
- Thalassemia
Mixed Evidence: Meta-analysis or systematic review is inconclusive, either because the aggregated data on the association between an underlying condition and severe COVID-19 outcomes are inconsistent in direction or there are insufficient data
- Alpha 1 antitrypsin deficiency
- Bronchopulmonary dysplasia
- Hepatitis B
- Hepatitis C
- Hypertension*
Footnotes:
* indicates underlying conditions for which there is evidence for pregnant and non-pregnant people
‡ underlying conditions for which there is evidence in pediatric patients
Learn More – Primary Sources:
NIH: Clinical Spectrum | COVID-19 Treatment Guidelines
CDC: Clinical Presentation | Clinical Care Considerations
CDC Coronavirus Disease 2019: Overview of Testing for SARS-CoV-2
Clinical Questions about COVID-19: Questions and Answers
WHO: Novel coronavirus Information Page
JAMA: Coronavirus Disease 2019
Annals of Internal Medicine: Content Related to Coronavirus in Annals of Internal Medicine
Aluminum and Vaccines – The Evidence for Continuing Safety
SUMMARY:
Aluminum has been present in vaccines as an adjuvant for over 70 years. By boosting immune response, aluminum reduces the amount of vaccine required to provide immunity. In the US, the two aluminum salts that are used are monophosphoryl A (a detoxified bacterial component), and squalene (a compound of the body’s normal cholesterol synthesis pathway). Aluminum in vaccines has an excellent safety record and according to the FDA,
The risk to infants posed by the total aluminum exposure received from the entire recommended series of childhood vaccines over the first year of life is extremely low, according to a study by the U.S. Food and Drug Administration (FDA).
Supporting Data
- The FDA (Vaccine, 2011) specifically addressed the issue of aluminum and vaccines due to public concern
- Using the most current infant exposures and research on the pharmacokinetics of aluminum, they calculated that an infant would be exposed over the first year of life to a maximum of 4.225 mg
- Based on minimal risk levels established by the ATSDR, the aluminum exposure to vaccines in the first year of life is well below this threshold
- Multiple other studies have similarly validated the safety profile of aluminum in vaccines (See CHOP reference summary in ‘Learn More – Primary Sources’ below)
Aluminum in Context
- Third most abundant element after oxygen and silicon
- Most abundant metal, making up almost 9 percent of the earth’s crust
- Found in multiple foods and vegetables, aside from storage containers
- Typical adult exposure is 7 to 9 mg/day
Aluminum Levels in Vaccines
- The aluminum in vaccines is similar to a liter of infant formula
- Infants receive approximately 4.4 milligrams of aluminum in the first six months of life from vaccines, which is less than they receive through diet
- Breast-fed infants ingest about 7 milligrams
- Formula-fed infants ingest about 38 milligrams
- Soy formula-fed infants ingest almost 117 milligrams of aluminum during the first six months of life
Recent Publication Linking Aluminum in Vaccines to Autism
- A recent publication by Li et al. (Journal of Inorganic Biochemistry 2017) exposed mice to aluminum vaccine adjuvants
- When compared to control mice, certain genes were over and under expressed in the mice that received aluminum injections
- In one example, the downregulation of NF-κB inhibitor resulted in the activation of the inflammatory pathways and released cytokines
- The authors claim these findings are ‘consistent with those in autism’ and that aluminum adjuvant promotes brain inflammation
Study Retraction
- Based on concerns that images in the Li et al. study may have been altered, John Dawson, the editor of the Journal of Inorganic Biochemistry, told ‘Retraction Watch’ that
The paper by Shaw and co-workers is being retracted jointly by the authors and the editor
Read more on the pending retraction at ‘Retraction Watch’ (see ‘Learn More’ below)
Other Study Limitations Beyond Altered Images
- Assumption that immune changes in mice brain adequately represent the underlying mechanism of autism in humans is unproven
- Mice used for these studies were not strains associated with autism
- Mice received 6 vaccine doses earlier in development then humans and over a few days compared to human vaccine which is scheduled over months
- For ease of experiment, injections were subcutaneous not intramuscular
- In the FDA study (Vaccine, 2015), the authors point out that intramuscular injection results in a depot effect with different kinetics than other routes of aluminum administration
- Genetic experiments are very dated
- Current methodology for gene expression is gene profiling, which is quantitative and looks at thousands of genes at the same time to understand gene/gene interactions due to complexity of pathways
- In this study, very few genes selected (based on old literature) and technology is no longer in use for expression in most laboratories as the older method is not truly quantitative
- Lack of precise quantification make study images difficult to accurately interpret
Read more on the limited quality of the Li et al. paper at ‘Science Blogs’ (see ‘Learn More’ below)
KEY POINTS:
- There is no clear evidence that inflammation causes autism
- Vaccines prevent inflammation by preventing significant infectious diseases
- Not all vaccines contain adjuvants
- According to the CDC, Aluminum is present in U.S. childhood vaccines that prevent hepatitis A | Hepatitis B | Diphtheria-tetanus-pertussis (DTaP, Tdap) | Haemophilus influenzae type b (Hib) | Human papillomavirus (HPV) and pneumococcus infection.
- Monophosphoryl lipid A is included in one human papillomavirus (HPV) vaccine, Cervarix. One licensed pandemic influenza vaccine contains an adjuvant called AS03. It is included in the US pandemic influenza vaccine stockpile, but it is not available to the general public.
- Fluad is a newly-licensed flu vaccine that contains MF59 as an adjuvant. MF59 is an oil-in-water emulsion that boosts the body’s immune response to this vaccine. In some vaccines, the weakened or inactivated virus stimulates a strong immune response so no additional adjuvant is needed for it to be effective to protect against infections.
- In the United States, vaccines against measles | Mumps | Rubella | Chickenpox | Rotavirus | Polio | And seasonal influenza vaccines do not contain added adjuvants.
Learn More – Primary Sources:
Updated aluminum pharmacokinetics following infant exposures through diet and vaccination
FDA Study Reports Aluminum in Vaccines Poses Extremely Low Risk to Infants
CDC: ATSDR Minimal Risk Levels (MRLs)
Updated aluminum pharmacokinetics following infant exposures through diet and vaccination
ScienceBlogs: Torturing more mice in the name of antivaccine pseudoscience, 2017 aluminum edition
Retraction Watch: Journal to retract paper called “anti-vaccine pseudoscience”
Children’s Hospital of Philadelphia: Vaccine Ingredients – Aluminum
ACC/AHA Blood Pressure Guideline: Current Classification System and Treatment Targets
SUMMARY:
The USPSTF released its latest recommendation regarding screening for hypertension in adults (2021). Based on current evidence demonstrating high certainty regarding net benefit, the task force reaffirms and “recommends screening for hypertension in adults 18 years or older with office blood pressure measurement. The USPSTF recommends obtaining blood pressure measurements outside of the clinical setting for diagnostic confirmation before starting treatment. (grade A recommendation)”.
The ACC/AHA task force report represents the work of several professional bodies based upon hundreds of studies. There are notable changes from previous practice guidelines, especially related to screening and detection. The ACC/AHA task force recommends the following classification system:
<120 mmHg and <80 mmHg: NORMAL BP
- Healthy lifestyle choices
- Yearly check-ups
120 to 129 mmHg and <80 mmHg: ELEVATED BP
- Healthy lifestyle changes
- Reassess in 3 to 6 months
130 to 139 mmHg or 80 to 89 mmHg: HIGH BP to STAGE 1
- 10-year heart disease and stroke risk assessment <10% risk
- Lifestyle changes
- Re-assess in 3 to 6 months
- 10-year heart disease and stroke risk assessment ≥10% risk
- Lifestyle changes
- Medication
- Monthly follow-up until BP is under control
≥140 mmHg or ≥90 mmHg: HIGH BP – STAGE 2
- Lifestyle changes
- Consider initiation of therapy with 2 different classes of medications
- Monthly follow-up until BP is under control
- If BP ≥160/100 mm Hg: Treat promptly, monitor carefully and adjust medication dose upward as necessary to achieve control
NOTE: Calculate 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk (see ‘Learn More – Primary Sources’ below)
Additional Hypertension Classifications
‘White Coat’ hypertension
- Elevated BP in the office but not outside the office
- Checking for ‘White Coat’ hypertension using either daytime Ambulatory Blood Pressure Monitoring (ABPM) or Home Blood Pressure Monitoring (HBPM) is “reasonable” if
-
- Office SBP is >130 but <160 mm Hg or
-
- Office diastolic BP (DBP) >80 but <100 mm Hg and
- Patient has failed to improve with 3 months of lifestyle modification
‘Masked’ hypertension
- Elevated BP out-of-office but not in-office
- Checking for ‘masked’ hypertension with daytime ABPM or HBPM is “reasonable if”
-
- Office SPB is 120 to 129 and DBP is <80 while not on antihypertensive medications or
- If patient is on antihypertensive therapy with office SPB of 120 to 129 and DBP is <80, and they have high risk comorbidities such as CKD, >10% risk of stroke, or signs of hypertension related end organ damage
Acute severe hypertension
- Severe hypertension: SBP ≥180 mmHg or DBP ≥120 mmHg with end organ damage (e.g., pulmonary edema, cardiac ischemia, neurologic deficits, acute renal failure, aortic dissection, and eclampsia) is termed hypertensive emergency. This is a medical emergency that requires hospital care.
- If no evidence of end organ damage this is termed hypertensive urgency can manage in ambulatory setting with close follow up
- Blood pressure should not be decreased abruptly to prevent cerebral hypoperfusion
Resistant hypertension
- Uncontrolled BP despite treatment with ≥3 antihypertensive agents of different classes (one of which is usually a diuretic)
The ACC/AHA task force also recommends the following as cut offs for hypertension when using at home BP measurements: >110/>65 mmHg for nighttime mean and >125/>75 mmHg for 24hr mean.
NOTE: Calculate 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk (see ‘Learn More – Primary Sources’ below)
KEY POINTS:
Risk Factors
- Genetic predisposition
- Complex polygenic disorder
- Rarely single gene disorder (e.g. Liddle’s or Gordon’s syndrome)
- Environmental Risk Factors
- Overweight and Obesity
- Sodium Intake
- Potassium
- Higher levels appear to blunt sodium effect on BP
- Lower sodium/potassium ratio may reduce risk of CVD
- Physical fitness
- Even modest levels of physical activity is associated with a decrease in the risk of incident hypertension
- Alcohol
- In US, may account for 10% of BP burden
- Also associated with higher HDL and at modest intake range, lower risk for CHD when compared to abstinence
Non-pharmacological Interventions
- Weight loss
- Goal: Optimum goal is ideal body weight but can expect 1mm Hg for every 1kg reduction
- Diet
- DASH diet: Fruits and vegetables, whole grains, low-fat dairy products, reduced saturated and total fat
- Other diets with supportive evidence
- Low in calories from carbohydrates
- High-protein diets
- Vegetarian diets
- Mediterranean dietary pattern
- Sodium: Goal <1500 mg/d, but aim for at least a 1000mg/d reduction
- Potassium: Goal 3500 to 5000 mg/d, preferably through diet
- Exercise – Recommend structured exercise program
- Aerobic: 90 to 150 min/wk; 65% to 75% heart rate reserve
- Dynamic resistance and Isometric resistance also shown to lower BP
- Alcohol Reduction (drink = 12 oz regular beer [5% alc] / 5 oz wine [12% alc] / 1.5 oz distilled spirits [40% alc])
- Women: ≤ 1 drink per day
- Men: ≤ 2 drink per day
Taking a BP
- Prep
- Avoid caffeine, exercise, smoking at least 30 minutes before
- Empty bladder
- No talking while measurement is taken
- Remove clothing covering cuff placement
- Patient should sit on chair, feet on floor and back supported for > 5 min before taking pressure (not lying or sitting on an exam table)
- Technique
- Validated device
- Support arm
- Middle of cuff on upper arm at level of atrium (midpoint of the sternum)
- Cuff size: Bladder should encircle 80% of the arm
- Can use either stethoscope diaphragm or bell
- Taking the measurement
- First visit: Record BP in both arms and use arm with higher reading for subsequent measurements
- Separate measurement by 1 to 2 minutes
- To estimate systolic BP, use radial pulse obliteration and then inflate cuff 20 to 30 mmHg higher
- Deflate cuff pressure 2 mmHg per second and listen for Korotkoff sounds
- Systolic BP: First Korotkoff sound
- Diastolic BP: Disappearance of all Korotkoff sounds
- Use nearest even number
- Note time of most recent BP medication before taking measurements
- Average the readings to estimate BP
- Use average of ≥ 2 readings obtained on ≥ 2 occasions
Note: The AHA has released a scientific statement that validated oscillometric devices allow accurate BP measurement in the outpatient setting, while reducing human errors associated with the auscultation.
Target BP Goal
- Known CVD or 10-year heart disease and stroke risk assessment ≥ 10% risk
- 130/80
- Without additional markers of increased CVD risk, a BP target of less than 130/80 mm Hg may be reasonable
Adults ≥ 65 years
- Treat to same goal of 130/80 as younger adults
- Recommendation differs with ACP and AAFP guidance that suggests a goal of 150/90
Pregnancy Recommendations
- Women with hypertension who become pregnant, or are planning a pregnancy should be transitioned to methyldopa, nifedipine, and/or labetalol during pregnancy
- Do not treat women with hypertension in pregnancy with ACE inhibitors, ARBs, or direct renin inhibitors
Oral Contraceptives and NSAIDs
- Oral contraceptives and NSAIDs are listed as commonly used medications that may cause elevated BP
- The ACC/AHA guideline recommends the following
OCPs
Use low-dose (e.g., 20 to 30 mcg ethinyl estradiol) agents or a progestin-only form of contraception, or consider alternative forms of birth control where appropriate (e.g., barrier, abstinence, IUD)
Avoid use in women with uncontrolled hypertension
NSAIDs
Avoid systemic NSAIDs when possible
Consider alternative analgesics (e.g., acetaminophen, tramadol, topical NSAIDs), depending on indication and risk
Learn More – Primary Sources:
10-year risk calculator using ASCVD algorithm
AHA AMA: BP Treatment Algorithm
Measurement of Blood Pressure in Humans: A Scientific Statement From the American Heart Association
Major CMS Change Regarding Medical Student Documentation
SUMMARY:
The Centers for Medicare & Medicaid Services (CMS) has made a major revision to the Medicare Claims Processing Manual, Chapter 12, Section 100.1.1 that updates the policy on documentation with respect to medical students. According to CMS, this revision will
…allow the teaching physician to verify in the medical record any student documentation of components of E/M services, rather than re-documenting the work. Students may document services in the medical record. However, the teaching physician must verify in the medical record all student documentation or findings, including history, physical exam and/or medical decision making. The teaching physician must personally perform (or re-perform) the physical exam and medical decision making activities of the E/M service being billed, but may verify any student documentation of them in the medical record, rather than re-documenting this work.
What New Provider Action is Needed?
- Previously, teaching physicians were required to re-document the medical student’s Evaluation and Management (E/M) documentation
- With this revision, the teaching physician can verify in the medical record any student documentation of components of E/M services
KEY POINTS:
- The CMS states that this change was “part of a broader goal to reduce administrative burden on practioners.”
- This change addresses concerns by medical education professionals and organizations that medical students entering residencies be familiar with documentation, particularly the use of electronic health records
- The ACP had passed resolution 3-F15 in 2015, calling on
CMS to change the 2008 guidelines to allow teaching physicians to refer to a student’s documentation of the history and physical examination findings or medical decision making in his or her personal note for documentation of an E&M service
- Billing departments should be made aware of these new changes
Medicare Claims Processing Manual
Changes in bold italics
Chapter 12-100.1.1 – Evaluation and Management (E/M) Services (Rev. 3971, Issued: 02- 02- 18, Effective: 01-01-18, Implementation: 03- 05-18) B. E/M Service Documentation Provided By Students Any contribution and participation of a student to the performance of a billable service (other than the review of systems and/or past family/social history which are not separately billable, but are taken as part of an E/M service) must be performed in the physical presence of a teaching physician or physical presence of a resident in a service meeting the requirements set forth in this section for teaching physician billing. Students may document services in the medical record. However, the teaching physician must verify in the medical record all student documentation or findings, including history, physical exam and/or medical decision making. The teaching physician must personally perform (or re-perform) the physical exam and medical decision making activities of the E/M service being billed, but may verify any student documentation of them in the medical record, rather than re-documenting this work.
Learn More – Primary Sources:
CMS Medical Learning Network: E/M Service Documentation Provided By Students (Manual Update)
CMS Medicare Claims Processing Manual Chapter 12 – Physicians/Nonphysician Practitioners
COPD Exacerbation: From Diagnosis to Treatment
SUMMARY:
COPD characterized by the cardinal symptoms of increased dyspnea, cough, and sputum purulence or production/volume. Classification is via Gold’s Classification (see Diagnosis and Management of Stable COPD in ‘Related Topics’ below). Exacerbations involve increased airway inflammation, increased mucus production and increased gas trapping. They are commonly precipitated by respiratory tract infections, although there can be many triggers. Exacerbations contribute to disease progression and are associated with increased mortality and morbidity.
Symptoms
- Cardinal symptoms of COPD
- Persistent dyspnea
- Chronic cough (+/-wheeze)
- Sputum production
- Exacerbation is seen in those with history of COPD with acute worsening of the following symptoms over <
- Dyspnea
- Sputum purulence
- Sputum production/volume
- Cough
- Wheezing
Risk Factors
- Diagnosis of COPD with previous exacerbations
- Occupational and indoor air pollution
- Infections
- Tobacco smoke
- Medication nonadherence
- Presence of one or more comorbidity
- Vitamin D deficiency
- It is recommended that all patients hospitalized for exacerbations should be tested for vitamin D deficiency and supplemented as needed
- Greater percentage of emphysema or airway wall thickness measured by CT chest
- Presence of chronic bronchitis
Differential Diagnosis
- Pneumonia
- Hypoxemia | Shortness of breath | Fever | Cough | Leukocytosis | Elevated inflammatory markers
- Pneumothorax
- Worsening dyspnea | Pleuritic chest pain | Diminished breath sounds | Can be seen on chest x-ray or ultrasound
- Pulmonary Embolism
- Sudden onset pleuritic chest pain | Tachycardia | Tachypnea | Hypoxia | Shortness of breath | Elevated D-dimer | Shown on CTA
- Pulmonary Edema secondary to acute decompensated heart failure
- History of cardiac disease (not always) | Dyspnea | Pink frothy sputum with cough | Crackles on exam | Elevated BNP | Echocardiogram is helpful in evaluation | Chest x-ray may show cardiomegaly and pleural effusions
- Cardiac arrythmia or myocardial infarction
- Atrial fibrillation (A Fib) and atrial flutter can oftentimes cause shortness of breath | A Fib can oftentimes trigger COPD exacerbation or be a consequence of it | Evaluate with EKG | Troponin
Treatment
Determine if Patient Can Be Treated Outpatient or Requires Hospitalization
- Outpatient criteria includes: Mild disease to moderate disease | One of three cardinal symptoms | Not meeting criteria for inpatient hospitalization
- Inpatient criteria includes
- Severe symptoms: Use of accessory respiratory muscles | Acute changes in mental status
- Hypoxemia not improved with supplemental oxygen
- PaCO2 >60mm Hg
- Acute respiratory failure with RR >30 breaths per minute
- Cyanosis | New peripheral edema
- Failure to respond to initial management
- Presence of serious co-morbidities (e.g., Heart failure | New arrhythmia)
- Insufficient home support
Initial Bronchodilators for Every Patient
- Short acting inhaled beta-2 agonists (SABA) preferred via metered dose inhaler (preferred due to quick onset of action)
- 1 to 2 puffs every 1 hour for 2 or 3 doses then every 2 to 4 hours depending on patient’s response
Muscarinic Antagonists
- Ipratropium bromide, a short acting muscarinic antagonist, often used in combination with SABA: 2 inhalations by MDI every 4 to 6 hours
- Combination ipratropium-albuterol inhaler hand-held inhaler (HHN): Preferred in inpatient treatment 1 inhalation, every hour for 2 to 3 doses and then every 2 to 4 hours as needed guided by the response to therapy
Systemic Corticosteroids
- Improve FEV1, oxygenation and shorten recovery and hospitalization time
- Pulmonary rehabilitations (breathing exercises), nutritional and psychologic support
- 40 mg of prednisone for 5 days
- Longer courses of steroids associated with increased risk of pneumonia and mortality
- Outpatient: Recommended only in those who present with breathlessness that affect daily activities
- Inpatient: Always get a course of systemic steroids
Note: European Respiratory Society/American Thoracic Society suggest a course of oral corticosteroids for 9–14 days in outpatients with COPD exacerbations in contrast to the GOLD guidelines
Antibiotics
- Consider antibiotics if
- Evidence of bacterial infection is present
- Presence of three cardinal symptoms
- At least two cardinal symptoms present with one being increased sputum purulence
- Severely ill patients such as those who require mechanical ventilation
- Procalcitonin is not recommended in antibiotic decision making
- Patients with recurrent exacerbations should get sputum culture to guide antibiotic treatment
- Duration 5 to 7 days for hospitalized patients | No more than 5 days for outpatients
- First line
- A 875/125mg BID
- Second or third generation cephalosporins (e.g., Ceftriaxone, cefdinir)
- Azithromcyin 500mg Day 1 followed by 250mg daily for 4 days
- Use of tetracyclines is recommended by GOLD guidelines, though a recent study has shown no benefit from Doxycycline use (see primary sources below)
- Community resistance patterns should be taken into account
Magnesium
- Magnesium sulfate infusion historically has been used for acute asthma exacerbations, but a recent study demonstrated benefit for acute COPD exacerbations
- For patients with severe COPD exacerbation not improving with standard bronchodilator therapy give 2g IV Magnesium sulfate over 20 minutes
Additional Inpatient Treatment Considerations
- Maintenance therapy
- Initiate long-acting bronchodilators once patient is stable
- Continue maintenance therapy through exacerbation
- While hospitalized, initiate a home therapy regimen as soon possible to assess response
Complications of Recurrent COPD Exacerbations
- Increased mortality and morbidity
- Hospitalization
- Intubation
- Secondary lung infections
Prevention
- Smoking cessation
- Ensure vaccines up to date, including influenza, Covid-19, Tdap, and pneumococcal vaccines
- Maintenance bronchodilators
- Pulmonary rehab referral within 4 weeks of hospital discharge
- Consider prophylactic antibiotics if a patient is prone to exacerbations after risk-benefit discussion including drug resistance and side effects such as GI upset
- Azithromycin 250mg per day or 500mg three times a week
- Erythromycin 250mg BID
Primary Sources – Learn More:
GLOBAL STRATEGY FOR PREVENTION, DIAGNOSIS AND MANAGEMENT OF COPD: 2023 Report
Magnesium sulfate for acute exacerbations of chronic obstructive pulmonary disease
Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline
Migraine Treatment and Prevention
CLINICAL ACTIONS:
Migraine is a complex neurologic event encompassing moderate to severe headache as well as systemic and neurologic symptoms. Treatment is aimed at both amelioration of symptoms as well as prevention of attacks. Dosage below is based on the Lancet (2018) review and International Headache Society (IHS) guidelines but may vary based on a patient’s medical and clinical circumstances.
ACUTE TREATMENT
General principles to manage acute migraine include
- Treat early (ideally within the first 20 mintutes of onset) while pain is mild
- Consider non-oral routes of administration for patients with nausea/vomiting or rapid pain peak (≤30 min)
- Nasal spray
- Injection
- Suppository
- Combination approach using medications with different mechanisms of action for those who do not obtain quick relief or relapse within 24 – 48 hours
- Educate patients regarding potential for medication-overuse
- Minimize use of ‘simple’ analgesics to <15 days per month and triptans, ergots, or combination analgesics to less than 10 days per month (see below for specific meds)
Simple analgesics – Effective for Mild Pain
- NSAIDS
- Aspirin 975 – 1000 mg
- Ibuprofen 400 mg
- Naproxen 500 – 550 mg (up to 825 mg)
- Diclofenac potassium 50 mg
- Indomethacin suppositories 50 mg
- May be cut into 1/2 or 1/3
- Acetaminophen
- Acetaminophen (Paracetamol) 1000 mg
- May be combined with NSAIDs and caffeine
Triptans – First Line for Moderate/Severe Pain
- Selective Serotonin 5-HT Receptor Agonists
- Contraindications due to vasoconstriction
- History of symptomatic peripheral, coronary, and cerebrovascular disease and severe hypertension
- Pregnancy
- May be associated with pregnancy-related vascular events, but data currently (mostly based on sumatriptan) has not demonstrated an association with birth defects
- Usually begin with acetaminophen, then aspirin/NSAIDs and use triptans as 3rd line therapy when indicated
- Triptans have an overall favorable safety profile when not contraindicated and available without subscription in some European countries
- Typical doses and routes
- Sumatriptan
- 6 mg subcutaneous
- 20 mg intranasal
- 50 mg oral
- 100 mg oral
- Zolmitriptan 5 mg intranasal/2.5 mg oral
- Almotriptan 12.5 mg oral
- Eletriptan 20-40 mg oral
- Frovatriptan 2.5 mg oral
- Naratriptan 2.5 mg oral
- Sumatriptan
- Patients may respond differently to different triptans and patient preference will also play a role (e.g. patients tend to prefer oral medications)
- Lasmitidan (Reyvow) highly selective 5-HT1f antagonist, is similar to triptans with a favorable adverse event profile
Dihydroergotamine
- Used when triptans are not well tolerated or patient not responding
- Alpha-adrenergic blocker and arterial vasoconstrictor
- 1 mg nasal spray, subcutaneous or IM
- Contraindications include
- Pregnant or nursing
- Cardiac or circulatory disease (similar to triptans)
- Additional contraindications due to life-threatening peripheral ischemia due to coadministration of dihydroergotamine with CYP 3A4 inhibitors
- Anti-HIV medications (protease inhibitors)
- Macrolide antibiotic such as clarithromycin or erythromycin
Opiods/Butalbital Containing Analgesics
- Best to avoid due to high incidence adverse events, habituation, addiction, and medication overuse headache with as little as 3 butalbital exposures per month
Note: The FDA has approved medications for treatment of migraine with and without aura, based on new classes of drugs (see ‘Primary Sources – Learn More’ below)
- Lasmiditan (Reyvow): A new class of serotonin (5-HT)1f receptor agonists
- Ubrogepant (Ubrelvy: An oral calcitonin gene–related peptide receptor antagonist
- Rimegepant (Nurtec ODT): An oral calcitonin gene-related peptide receptor antagonist
PREVENTATIVE TREATMENT
- Consider preventative treatment
- When ≥ 8 headache days/month or ≥4 migraines/month
- For patients with chronic migraine
Beta Blockers
- Atenolol (B level evidence): 50 to 200 mg once a day
- Metoprolol (A level evidence): 50 to 200 mg once a day for long-acting formulation
- Nadolol (B level evidence): 20 to 160 mg once a day
- Propranolol (A level evidence): 40 to 240 mg once a day for long-acting formulation
- Timolol (A level evidence): 20 to 60 mg once a day
Antidepressants
- Amitriptyline (B level evidence): 10 to 50 mg before bed
- Nortriptyline (no studies available): 10 to150 mg before bed
- Venlafaxine (B level evidence): 75 to 225 mg once a day for long-acting formulation
Calcium-Channel Blockers and Anticonvulsants
- Verapamil (U level evidence): 120 to 960 mg in divided doses for long-acting formulation
- Flunarizine (A level evidence): 5 to 10 mg once a day
- Gabapentin (U level evidence): 600 to 3600 mg in two–three divided doses
- Topiramate (A level evidence): 50 to 200 mg twice a day or before bed
- Pregnancy Risk: FDA category D due to strong association with birth defects
- Valproic acid–divalproex (A level evidence): 500 – 2000 mg once a day or in two divided doses
- Pregnancy Risk: FDA category D due to strong association with birth defects
Angiotensin-converting enzyme inhibitors, angiotensin receptor blockers
- Lisinopril (C level evidence): 10 to 40 mg once a day
- Candesartan (C level evidence): 16 to 32 mg once a day
- Pregnancy Risk: FDA category D due to strong association with birth defects
- Cyproheptadine (C level evidence): 4 to 16 mg before bed
- Ibuprofen (B level evidence): 200 mg twice a day
- Fenoprofen (B level evidence): 200 to 600 mg twice a day
- Ketoprofen (B level evidence): 50 mg three times a day
- Naproxen (B level evidence): 500 to 1100 mg once a day
- Naproxen sodium (B level evidence): 550 mg twice a day
Calcitonin Gene-Related Peptide (CGRP-R) ModulatorsBlockers. A relatively new class of migraine therapies that are highly efficacious
- Galcanezumab (Emgality): 240mg once as loading dose, then 120mg once monthly subcutaneously (self-administered)
- Fremanezumab (Ajovy): 225mg once monthly subcutaneously (self-administered)
- Rimegepant (Nurtec ODT): 75 mg orally taken once every other day (dissolving tablet)
- Atogepant (Qulipta): 10, 30, or 60mg orally taken once every day
- Eptinezumab (Vyepti): 100mg IV administered every 3 months. Some patients may benefit from 300mg IV administered every 3 months
- Erenumab (First FDA-approved CGRP-R blocker for migraine prevention): 70mg once monthly subcutaneously (self-administered)
- Some patients may benefit from a dosage of 140mg once monthly administered once monthly as two consecutive injections of 70mg each
Miscellaneous agents
- Acupuncture (minimum of 6 sessions prior to realized therapeutic effect)
- Dry needling
- Feverfew (B level evidence): 50 to 82 mg once a day
- Riboflavin (B level evidence): 400 mg once a day or 200 mg twice a day
- Ubidecarenone (coenzyme Q10) C 300 mg once a day
- Magnesium citrate (B level evidence): 400 to 600 mg once a day
- OnabotulinumtoxinA also called botulinum toxin type A (A level evidence): 155 to 195 mg once every 12 weeks (for chronic migraine)
- FDA approved for chronic, not episodic migraine
Notes: (Canadian Headache Society Guidelines)
- Level A: drug has been established as effective | Level B: drug is probably effective | Level C: drug is possibly effective (requires at least one class 2 study or two consistent class 3 studies) | Level U: data are inadequate or conflicting, treatment is unproven
SYNOPSIS:
Treatment of migraines is intended to reduce the acute symptoms as well as prevent future events. A multitude of medical therapies are available to this end. When starting therapy begin with the lowest dose and escalate slowly. A 2-3 month trial is necessary to determine efficacy. 6 months may be needed to achieve maximal result.
KEY POINTS:
- Patient using oral sumatriptan but headache not resolved within 2 hours or returns after transient improvement
- Second dose may be administered at least 2 hours after the first dose
- Maximum daily dose is 200 mg in a 24-hour period
- Discuss family planning with all women of childbearing age; review adverse effects on pregnancy prior to initiating treatment
- Emerging treatments include:
- Neuromodulation devices
- External trigeminal nerve stimulation
- Noninvasive vagus nerve stimulation
Learn More – Primary Sources
Mother To Baby: Sumatriptan Fact Sheet
FDA HIGHLIGHTS OF PRESCRIBING INFORMATION: UBRELVY (ubrogepant)
AAFP: Approach to Acute Headache in Adults
BMJ: Management of chronic migraine
Lyme Disease: Diagnosis and Treatment
SUMMARY:
Lyme disease is a serious condition caused by six species of spirochetal bacteria, most commonly Borrelia burgdorferi in North America, following a deer tick bite that requires treatment. Clinical disease can occur within days to several months following a tick bite. Lyme disease is endemic to the northeastern states from Virginia to eastern Canada, the upper Midwest, particularly Wisconsin and
Minnesota, and northern California. The following provides key points regarding diagnosis, treatment, prophylaxis and tick removal.
DIAGNOSING LYME DISEASE:
Early localized disease features:
- Erythema migrans (EM)
- 70 to 80% of infected individuals
- At site of tick bite approximately day 7 to 14 days after bite (range 3 to 30 days)
- Expands slowly and develops central clearing
- May have multiple lesions indicating disseminated disease (not multiple tick bites)
- Fever, headache, and fatigue
- Joint and muscle aches
- Swollen lymph nodes
Ixodes tick and Erythema Migrans images courtesy DermNetNZ.org
Early disseminated disease features:
- Neurologic symptoms: lymphocytic meningitis | cranial nerve palsies |radiculopathy | mononeuropathy multiplex | peripheral neuropathy
- Carditis: palpitations | chest pain | light headedness | fainting | shortness of breath | and difficulty breathing with exertion
- Multiple EM lesions
- Conjunctivitis
Late disease features (months to years after tick bite):
- Large joing polyarthralgia
- Confluent mononeuropathy multiplex
- Encephalomyelitis
Testing
Note: The CDC has updated the Lyme laboratory screening algorithm
- CDC still recommends the two step approach
- Step 1: Serologic testing using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay
- Step 2: Follow step one with a western immunoblot assay for specimens yielding positive or equivocal results
- Modified two-step approach
- Two enzyme immunoassays (EIA) are run concurrently or sequentially
- The CDC states that
When cleared by FDA for this purpose, serologic assays that utilize a second EIA in place of western immunoblot assay are acceptable alternatives for the serologic diagnosis of Lyme disease
Note: When EM is present and patient has been to a Lyme endemic area serologic testing is not recommended and treatment can be initiated following clinical diagnosis
KEY POINTS:
- Two-tiered serologic testing is more sensitive the longer infection has been present
- Myth that Lyme disease can become chronic and no longer detectable on lab testing
- Testing can remain positive for years so can not be used to test for cure
Treatment
- First line therapy for adults with early localized Lyme disease
- Doxycycline: 100 mg twice per day for 10 days, or
- Amoxicillin: 500 mg 3 times per day for 14 days, or
- Cefuroxime axetil: (500 mg twice per day) for 14 days
- Therapy for early disseminated Lyme disease with neurologic manifestations:
- Doxycycline: 100 mg twice per day for 14 to 21 days, or
- Ceftriaxone IV: 2 g daily for 14 to 21 days
- Therapy for early disseminated Lyme disease with mild carditis (1st degree AV block with PR interval ≤ 300 milliseconds):
- Doxycycline: 100 mg twice per day for 14 to 21 days, or
- Amoxicillin: 500 mg three times per day for 14 to 21 days, or
- Cefuroxime: 500 mg twice per day orally for 14 to 21 days
- Therapy for early disseminated Lyme disease with severe carditis (symptomatic, 1st degree AV block with PR interval ≥ 300 milliseconds):
- If severe carditis (symptomatic, 1st degree AV block with PR interval ≥300 milliseconds, 2nd or 3rd degree AV block) then patient should be admitted for telemetry monitoring and treated with Ceftriaxone IV 2 g daily for 14 to 21 days
- For treatment of late Lyme disease, including arthritis, the antibiotic course is extended to 28 days using the above antibiotics for early localized disease
- The CDC concurs with the following IDSA recommendation that advises strongly against the treatment of chronic Lyme disease (highest level of evidence ‘I’, based on randomized controlled trials) as overtreatment with unnecessary antibiotics may prove fatal (e.g. septic shock, C. difficile, paraspinal abscess and osteomyelitis):
There is no convincing biologic evidence for the existence of symptomatic chronic B. burgdorferi infection among patients after receipt of recommended treatment regimens for Lyme disease. Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic (⩾6 months) subjective symptoms after recommended treatment regimens for Lyme disease.
Prophylaxis: Management of asymptomatic individuals following a tick bite
- Routine use of antimicrobial prophylaxis or serologic testing is not recommended
- A single dose of doxycycline may be offered to adult patients (200 mg dose) when all the following are met:
- The attached tick can be reliably identified as an adult or nymphal I. scapularis deer tick that is estimated to have been attached for ⩾36 hours based on the degree of engorgement of the tick with blood or on certainty about the time of exposure to the tick
- Prophylaxis can be started within 72 hours of the time that the tick was removed
- Ecologic information indicates that the local rate of infection of these ticks with B. burgdorferi is ⩾20% (occurs in parts of New England, in parts of the mid-Atlantic States, and in parts of Minnesota and Wisconsin)
- Doxycycline is not contraindicated
Tick Removal
- The risk of getting a tick-borne disease is small if the tick is removed soon after it becomes attached
- Deer ticks must remain attached one to two days to transmit Lyme disease, and about one day for other tick-borne diseases
- Use tweezers to grasp the tick close to its mouth
- Gently and slowly pull the tick straight outward
- To avoid contact with the bacteria, if present, do not squeeze the ticks’ body
- Wash the area and apply an antiseptic to the bite
- Watch for early signs and symptoms of Lyme disease
Learn More – Primary Sources:
CDC: Lyme Disease Diagnosis, Treatment and Testing
Signs and Symptoms of Untreated Lyme Disease
Minnesota Department of Natural Resources: Deer Ticks
CDC: Lyme Disease Transmission
JAMA: Lyme Disease in 2018 – What Is New (and What Is Not)
FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses
CDC: Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease
BMJ State-of-the-Art Review: Lyme borreliosis: diagnosis and management
Is It a Migraine? Risk Factors and Diagnostic Categories
CLINICAL ACTIONS:
Migraine is a complex neurologic disorder including both moderate to severe headache along with a variety of neurologic and systemic symptoms. Common symptoms include hypersensitivity to light and sound, cutaneous pain sensitization, and GI symptoms.
- Migraine symptoms are often described as follows
- Unilateral (60%)
- Throbbing (50%)
- Aggravated by physical activity or head movement (90%)
- Neck pain
- Aura may include
- Flashes of light | Partial loss of vision | Parasthesias | Vertigo | Ataxia | Diplopia
- Symptoms are typically bilateral, sequential (visual, then sensory) and recurrent in nature
Migraine Categories
Migraine with aura (with at least two attacks fulfilling the two following criteria)
- One or more of the following fully reversible aura symptoms
- Visual
- Sensory
- Speech and/or language
- Motor
- Brainstem
- Retinal
- At least three of the following six characteristics
- At least one aura symptom spreads gradually over ≥5 minutes
- ≥2 aura symptom in succession
- Each individual aura symptom lasts 5–60 minutes
- ≥1 aura symptom is unilateral
- ≥1 aura symptom is positive for scintillations and pins and needles
- Aura is accompanied, or followed within 60 minutes, by headache
Note: Not better accounted for by another diagnosis
Migraine without aura (at least 5 attacks fulfilling the following criteria)
- Headache lasting 4-72 hours (untreated or successfully treated)
- Headache has at least two of the following characteristics
- Unilateral | Pulsating | Moderate/severe intensity | Aggravated by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
- At least one of the following during the headache
- Nausea and/or vomiting | Photophobia | Phonophobia
- Other disorders ruled out (e.g. meningitis)
Chronic Migraine Definition
- Headache on more than 15 days/month for >3 months
- ≥ 8 days meet diagnostic criteria for migraine with or without aura
- Not better accounted for by another diagnosis
SYNOPSIS:
The WHO lists migraine as the sixth highest cause worldwide of years lost due to disability. Migraine may not always present with typical symptoms and can be bilateral, mild, non-throbbing, with facial pain and hence confused with tension or sinus headache. It may be preceded by prodromal symptoms hours or days before headache. Symptoms can include fatigue, neck stiffness and impaired concentration. Postdromal symptoms occur up to 24 hours after headache may include weakness, fatigue, somnolence, photophobia, impaired concentration, irritability and nausea.
KEY POINTS:
- Prevalence peaks between ages 30 to 39 and is uncommon after the age of 60 and prior to adolescence
- In women, the annual and lifetime prevalence are 18% and 33%
- A minority (<10%) of women have attacks of migraine in association with most of their menstrual cycles
- Usually without aura
- Tend to be longer and accompanied by more severe nausea
- 8% of the migraine population has chronic migraine
- Risk factors for chronic migraine
- Overuse of acute medications
- Inadequate treatment of acute attack
- Caffeine consumption
- Snoring
- Obesity
- Female sex
- Allodynia (perception of pain when non-painful stimuli are applied to the skin)
- Head injury
- Low socioeconomic status
- Depression, anxiety, pain disorders
LEARN MORE – PRIMARY SOURCES:
AAFP: Approach to Acute Headache in Adults
BMJ: Management of chronic migraine
ACC/AHA Multisociety Guideline: Cholesterol Assessment and Primary ASCVD Prevention
SUMMARY:
2018/2019 ACC/AHA Multisociety Guideline on the Management of Blood Cholesterol provides recommendations for the evaluation and prevention of ASCVD. The ‘ASCVD Risk Estimator Plus for Primary Prevention’ link is provided in the ‘Learn More – Primary Sources’ section below.
Algorithm Assessment for Primary Prevention (age 40-75)
Algorithm Assessment for Primary Prevention (age 40 to 75)
Non-Diabetic
LDL-C: <70 mg/dL
- Assess lifetime risk
LDL-C: 70 to189 mg/dL
- High Risk: 10-year risk ≥20%
- High intensity statin
- Aim for LDL-C lowering ≥50%
- High intensity statin
- Intermediate Risk: 10-year risk ≥7.5% to <20%
- ‘Risk Enhancers’ (see ‘Key Points’ below) favor starting statin therapy
- Consider coronary artery calcium (CAC) score if statin decision uncertain
- 0 score: Lowers risk (consider no statin, especially nonsmoker without family history of premature CHD)
- 1 to 99 score: Favors statin (especially > 55 years)
- 100+ score and/or ≥75th percentile: Initiate statin therapy
- Moderate intensity statin
- Aim for LDL-C lowering 30 to 50%
- Borderline Risk: 10-year risk 5 to <7.5%
- Initiate risk discussion regarding statin benefits based on risk enhancers
- Lifestyle changes
- Selective moderate statin
- Low Risk: 10-year risk <5%
- Lifestyle and risk discussion (Diet, physical activity, weight/BMI, tobacco use)
LDL-C: ≥190 mg/dL (primary severe hypercholesterolemia)
- Maximum tolerated statin is recommended
- If LDL-C ≥100 mg/dL: Adding ezetimibe is reasonable
- PCSK9 inhibitor may be considered in circumstances where LDL-C baseline is very high (≥220 mg/dL) and levels remain elevated (≥130 mg/dL) despite statins and ezetimibe
Diabetic Patient
LDL-C: 70 to 189 mg/dL
- Moderate intensity statin
- Aim for LDL-C lowering 30 to 50%
- High intensity statin
- If Multiple ASCVD risk factors and 50 to 75 y of age
- Diabetes-specific risk enhancers
- Long duration (≥10 years for type 2 diabetes or ≥ 20 years for type 1 diabetes)
- Albuminuria ≥30 mcg albumin/mg creatinine
- eGFR <60 ml/min/1.73 m2
- Retinopathy
- Neuropathy
- ABI (ankle-brachial index) <0.9
KEY POINTS:
Risk Enhancers
- Family history of premature ASCVD
- Males <55 years | Females <65 years
- Primary hypercholesterolemia
- LDL-C 160 to 189 mg/dL (4.1 to 4.8 mmol/L)
- Non-HDL-C 190 to 219 mg/dL (4.9 to 5.6 mmol/L)
- Chronic kidney disease
- eGFR 15 to 59 ml/min per 1.73 m2 with or without albuminuria
- Not treated with dialysis or kidney transplantation
- Metabolic syndrome
- Conditions specific to women
- Preeclampsia
- Premature menopause (before age 40)
- Inflammatory disease, especially
- Psoriasis
- RA
- HIV
- Ethnicity
- Asian | Hispanic/Latino | Black
- “Heterogeneity in risk according to racial/ethnic groups and within racial/ethnic groups. Native American/Alaskan populations have high rates of risk factors for ASCVD compared to non-hispanic whites.”
- Lipid/biomarkers
- Persistently elevated triglycerides (≥175 mg/dL)
- Additional markers if measured
- High sensitivity (hs)-CRP: ≥2.0 mg/L
- Lp(a) levels: ≥50 mg/dL or ≥125 nmol/l
- apoB: ≥130 mg/dL especially at higher levels of Lp(a)
- Elevated apo B ≥130 mg/dL corresponds to an LDL-C >160 mg/dL and constitutes a risk enhancing factor
- ABI (ankle-brachial index) <0.9
Lifestyle Discussion
Should be discussed and emphasized in each age group
- Age 0 to 19
- Lifestyle discussion
- Obtain family history for Familial Hypercholesterolemia (see ‘Related ObG Topics’ below) which may require early preventative medical intervention
- Age 20 to 39
- Lifestyle discussion
- Consider statin if
- Family history | Premature ASCVD | LDL-C ≥160 mg/dL (≥4.1 mmol/L)
- Age 40-75
- LDL-C ≥70 to <190 mg/dL (≥1.8 to <4.9 mmol/L) without diabetes mellitus
- 10-year ASCVD risk percent assessment (see algorithm above)
- LDL-C ≥70 to <190 mg/dL (≥1.8 to <4.9 mmol/L) without diabetes mellitus
Statin Therapy
High Intensity (≥50% LDL-C lowering)
- Primary Statins
- Atorvastatin 40 to 80 mg
- Rosuvastatin 20 to 40 mg
Moderate-Intensity (30% to 49% LDL-C lowering)
- Primary Statins
- Atorvastatin 10 mg to 20 mg
- Rosuvastatin 5 mg to 10 mg
- Simvastatin 40 mg
- Other Statins
- Pravastatin 40 mg
- Lovastatin 40 mg
- Fluvastatin XL 80 mg
- Fluvastatin 40 mg BID
- Pitavastatin 1 to 4 mg
Low-Intensity (<30% LDL-C lowering)
- Primary Statins
- Simvastatin 10 mg
- Other Statins
- Pravastatin 10 to 20 mg
- Lovastatin 20 mg
- Fluvastatin 20 to 40 mg
Note: Repeat lipid measurements within 4 to 12 weeks after starting therapy and assess response as well as lifestyle changes
Statin Side Effects
Statin Associated Muscle Symptoms (SAMS)
- Myalgias (1 to 5% in RCT and 5 to 10% in observational studies)
- Myositis/Myopathy (rare)
- Weakness
- Rhabdomyolysis (rare)
- Statin-associated autoimmune myopathy (rare)
New Onset Diabetes
- More common with risk factors (e.g., obesity)
Liver
- Elevated transaminase (infrequent)
- Hepatic failure (rare)
CNS
- Impact on memory/cognition (rare/unclear)
Cancer
- No definite association
Note: USPSTF differs from ACC/AHA Guidance
Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication (2022)
- Adults aged 40 to 75 years who have 1 or more cardiovascular risk factors (e.g., dyslipidemia, diabetes, hypertension, or smoking)
- Estimated 10-year risk of a cardiovascular event of 10% or greater (Grade B): Prescribe a statin for the primary prevention of CVD
- Estimated 10-year CVD risk of 7.5% to less than 10% (Grade C): Selectively offer a statin for the primary prevention of CVD
- Adults 76 years or older
- Current evidence is insufficient to assess the balance of benefits and harms of initiating a statin for the primary prevention of CVD events and mortality (Grade I)
Learn More – Primary Sources:
2018 ACC/AHA Multisociety Guideline on the Management of Blood Cholesterol
New Cholesterol Guidelines Personalize Risk and Add Treatments
ASCVD Risk Estimator Plus for Primary Prevention
JAMA Viewpoint: Reexamining Recommendations for Treatment of Hypercholesterolemia in Older Adults
Hospital Error Reports: Do They Have to be Disclosed?
In 2004, the New Jersey Patient Safety Act was signed into law. The statute was designed to improve patient safety in hospitals and other health care facilities by establishing a medical error reporting system. The system promotes comprehensive reporting of adverse patient events, systematic analysis of their causes, and creation of solutions that will improve health care quality and save lives. The goal is not to point fingers or assign blame.
In Conn vs. Rebustillo, the medical malpractice action involved a patient who fell out of bed while hospitalized, suffered a brain hemorrhage, and later died. The hospital conducted an internal root cause analysis which was submitted to the state health department along with a Patient Safety Act report. The attorneys for the deceased patient sought disclosure of the documents to show that the hospital had not complied with all of the process requirements of the Patient Safety Act. The trial judge ruled that the root cause analysis had to be disclosed along with any other withheld documents that were part of the root cause analysis process.
The hospital appealed the ruling. The Appellate Division reversed the decision of the trial court. It found that the privilege established in the Patient Safety Act is an absolute privilege and protects all documents submitted to the Department of Health, including the root cause analysis. In addition, the internal documents prepared by the hospital as part of its Patient Safety Act investigation which were not submitted to the state health department were also protected from disclosure if the hospital can show that the documents were developed as part of a Patient Safety Act plan which complies with the requirements of the Patient Safety Act. This ruling applies even if the facility fails to comply with reporting requirements.
This ruling is applicable in New Jersey only. Reporting and disclosure of medical errors varies widely across the United States and is frequently in flux depending on the courts overseeing each case.. In the 2009 Yale Journal of Health Policy, Law and Ethics, twenty-seven states had instituted medical error reporting systems, with the vast majority (21 states) containing explicit protections against legal discoverability of error reports in civil actions. More recently (2017) the Supreme Court of Florida overturned a prior ruling shielding patient safety reports, stating that “health care provider or facility … cannot shield documents not privileged under state law or the state constitution by virtue of its unilateral decision of where to place the documents under the voluntary reporting system created by the [PSQIA].” Hospital error report disclosures will continue to vary state by state and evolve with further court rulings.
Learn More – Primary Sources:
NJ State Patient Safety Reporting System
National Law Review: Appellate Division Accords Absolute Privilege To Patient Safety Act Materials
A National Survey of Medical Error Reporting Laws
Court rules patient-safety info subject to litigation discovery
Guideline for the Treatment of Community-Acquired Pneumonia: Outpatient Diagnosis and Management
CLINICAL ACTIONS:
Community-acquired pneumonia (CAP), by definition, is pneumonia acquired outside a hospital. A joint guideline (2019) from the American Thoracic Society/IDSA addresses diagnosis, management and follow-up. The focus of this document is on non-immunocompromised individuals (e.g., those without inherited or acquired immune deficiency or drug-induced neutropenia, those actively receiving cancer chemotherapy, HIV with suppressed CD4 counts or transplant recipients).
Diagnosis (CDC)
- History
- Abrupt onset of fever, chills or rigors
- Typically, a single rigor and repeated shaking chills are not commonly seen
- Older individuals may not mount a fever
- Pleuritic chest pain
- Cough productive of mucopurulent, rusty sputum
- Abrupt onset of fever, chills or rigors
- Clinical exam
- Dyspnea
- Tachypnea or tachycardia
- Hypoxia
- Malaise or weakness
- Altered Mental Status
- Nausea, vomiting and headache may occur, but is less common
- Auscultation
- Crackles
- Dullness to percussion, egophony (voiced sounds more audible than usual) may signal consolidation
- Lab
- Elevated WBC
- Imaging
- Guideline recommends radiographic confirmation with plain chest film (evidence of infiltrate) due to inaccuracy of clinical findings
Decision to Treat as Outpatient vs Inpatient
- In addition to clinical judgment, the Pneumonia Severity Index (PSI) can be used to determine treatment setting (see ‘learn more’ for calculators)
- PSI is considered superior to CURB-65 based on RCTs although CURB-65 has the benefit of simplicity and ease of use
- The score predicts probability of mortality
- PSI is a points-based system that uses the following features
- Age | Comorbidities | Abnormal physical findings (e.g., respiratory rate of ≥30 or a temperature of ≥40 degrees C) | Abnormal labs (e.g., pH <7.35, a BUN ≥30 mg per dL (11 mmol per liter) or a sodium concentration <130 mmol per liter | Presence of pleural effusion
- QXMD PSI Calculator
Tests at Time of Diagnosis if Managed in the Outpatient Setting
- Gram stain and culture of lower respiratory secretions: Not recommended
- Blood cultures: Not recommended
- Legionella and Pneumococcal Urinary Antigen Testing: Not recommended (unless epidemiologic reasons, i.e., recent outbreak)
- Influenza: Recommended during periods of high influenza activity | Consider during periods of low influenza activity
- Use rapid influenza molecular assay (i.e., influenza nucleic acid amplification test) vs rapid influenza diagnostic test (i.e., antigen test)
- Patient tests positive: Treat with anti-influenza medication (e.g., oseltamivir) independent of length of time of illness before diagnosis
- Treat with standard antibacterial treatment (see below) for patients with clinical and radiographic evidence of CAP
- Serum Procalcitonin: Should not be used to determine whether to withhold antibiotics
- Some studies have indicated that serum procalcitonin could discriminate between viral and bacterial infection (biomarker levels higher in bacterial disease)
- No clinical threshold has been established, with sensitivities ranging from 38% to 91%
Note: The American Thoracic Society has published guidelines regarding nucleic acid-based testing for viral pathogens in the setting of CAP
- Outpatients with suspected CAP
- Recommendation against testing for respiratory samples for viral pathogen other than influenza (conditional recommendation, very-low-quality evidence)
- Hospitalized patients with suspected CAP
- Recommendation against routine testing other for influenza unless severe CAP or immunocompromised (conditional recommendation, very-low-quality evidence)
SYNOPSIS:
Approximately 400,000 hospitalizations from pneumococcal pneumonia occur annually in the US. Pneumococci are responsible for up to 30% of adult CAP, with an incubation period of approximately 1 to 3 days. According the CDC, “the case-fatality rate is 5–7% and may be much higher among elderly persons.” Other bacterial pathogens include Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, Legionella species, Chlamydia pneumoniae, and Moraxella catarrhalis. According the guideline, “The newer multidrug-resistant pathogens, including methicillin-resistant S. aureus (MRSA) and Pseudomonas aeruginosa requires separate treatment options.”
KEY POINTS:
Treatment
No comorbidities or Risk Factors for MRSA or Pseudomonas aeruginosa
- Amoxicillin 1 g three times daily (strong recommendation) or
- Doxycycline 100 mg twice daily (conditional recommendation) or
- Macrolide (conditional recommendations and only in areas with pneumococcal resistance to macrolides <25%): Azithromycin 500 mg on first day then 250 mg daily or clarithromycin 500 mg twice daily or clarithromycin extended release 1,000 mg daily
Outpatient with Comorbidities (can be ‘combination therapy’ or ‘monotherapy’ with no order of preference)
Combination Therapy (Amoxicillin/clavulanate or cephalosporin combined with a macrolide or doxycycline)
- Amoxicillin/clavulanate 500 mg/125 mg three times daily or amoxicillin/clavulanate 875 mg/125 mg twice daily or 2,000 mg/125 mg twice daily or
- Cephalosporin: Cefpodoxime 200 mg twice daily or cefuroxime 500 mg twice daily
Plus
- A macrolide: Azithromycin 500 mg on first day then 250 mg daily or clarithromycin 500 mg twice daily or extended release 1,000 mg once daily or
- Doxycycline 100 mg twice daily
Monotherapy
- Respiratory fluoroquinolone: Levofloxacin 750 mg daily or
- moxifloxacin 400 mg daily or
- Gemifloxacin 320 mg daily
Note: Comorbidities include: Chronic heart | Lung, liver, or renal disease | Diabetes mellitus | Alcoholism | Malignancy | Asplenia
Duration of Antibiotic Treatment and Follow-Up
- Antibiotic treatment in patients who are improving “should be continued until the patient achieves stability and for no less than a total of 5 days (strong recommendation, moderate quality of evidence)”
- Evidence of clinical stability includes
- Resolution and stabilization of vital signs
- Ability to eat
- Normal mentation
- Need for follow-up chest film
- In patients who recover within 5 to 7 days, the guideline suggests that routine CXR follow up is not required
- However can use this as an opportunity to discuss lung cancer screening with patients that qualify
Learn More – Primary Sources:
Outpatient vs. Inpatient Treatment of Community-Acquired Pneumonia: PSI and CURB-65 Scoring Models
Affidavit of Merit : Gatekeeper to the Courthouse
In some states, an affidavit of merit is a requirement for medical malpractice lawsuits. Its purpose is to have an expert, a physician in this instance, state that the lawsuit has merit. The expert is required to review the case or the nature of the injuries. Then, the expert must opine that the harms the injured person suffered arose because that person received care that did not meet the relevant medical standards. It is a measure enacted to deter frivolous lawsuits.
Courts have been both lax and rigid in demanding these affidavits of merit. For example, in 2016, New Jersey appellate judges upheld the dismissal of a case with prejudice, meaning that the lawsuit could not be filed again. The plaintiff’s expert’s qualifications did not “match up” with the specialties of the defendant-physicians. The plaintiff’s attorneys had obtained an affidavit from a general surgeon to opine as to the standard of care that a pediatric critical care doctor and pediatric surgeon must adhere to. In addition, the expert was not an actively practicing clinician at the time.
For defendant practitioners, if your state requires such an affidavit, review it carefully with your defense counsel as to the expert’s qualifications during the pretrial period. It might be wise to challenge any expert who could be lacking the expertise for the standard of care involved in your case.
Diagnosis and Management of Stable COPD
SUMMARY:
Chronic obstructive pulmonary disease (COPD), a progressive respiratory condition characterized by dyspnea due to airflow limitation, is the fourth leading cause of death worldwide, and its prevalence is expected to increase in the coming decades. Though it is strongly associated with smoking, other causes include air pollution, indoor biomass fuel exposure, and occupational exposure to hazardous gases and dusts. There are also genetic and developmental factors that may predispose a person to developing COPD. The underlying pathophysiology of COPD involves chronic inflammation of the small airways leading to airflow limitation and gas trapping, in conjunction with destruction of the lung parenchyma which impairs gas exchange and promotes CO2 retention. Treatment is primarily aimed at alleviating symptoms, as there are currently few therapies that alter the progressive course of the disease. COPD is commonly associated with multiple medical comorbidities, and patients periodically suffer exacerbations during which symptoms acutely worsen, sometimes requiring emergency care or hospitalization. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) provides an evidence-based guide for practitioners to diagnose and treat COPD, which is summarized below.
KEY POINTS:
Diagnosis
Symptoms
- Cardinal symptoms
- Persistent dyspnea
- Chronic cough (+/-wheeze)
- Sputum production
- Severe disease
- Fatigue
- Weight loss
- Anorexia (associated with poor prognosis)
Spirometry
- FEV1/FVC < 0.70 (post-bronchodilator) confirms diagnosis of COPD
- Should be repeated at least annually in patients with COPD
- Population-based screening spirometry not recommended
Additional Work-Up
- Assess exercise impairment (e.g. 6-minute walk test)
- Screen all patients with COPD once for alpha-1-antitrypsin deficiency looking for hereditary sources
- Differentiating COPD from asthma
- Asthma usually presents with earlier onset
- Asthma symptoms vary widely day-to-day
- Asthma generally associated with allergic rhinitis/eczema (“atopic triad”)
Disease Severity
GOLD Criteria for Classifying Disease Severity
- Spirometry alone is insufficient for making individual treatment decisions
- Patients with severe airflow limitation on spirometry may have minimal symptoms (and vice versa)
- GOLD grade vs group
- Grade (1-4): Refers to severity of airflow limitation (based on spirometry)
- Group (A-D): Considers patient-reported symptoms and exacerbation risk
Note: Patients with COPD are assigned both a grade and a group
Grade System (1 to 4)
- (1-4) for classifying severity of airflow limitation (for patients with FEV1/FVC <0.70)
- GOLD 1 (mild): FEV1 ≥80% predicted
- GOLD 2 (moderate): 50% ≤FEV1 <80% predicted
- GOLD 3 (severe): 30% ≤FEV1 <50% predicted
- GOLD 4 (very severe): FEV1<30% predicted
Group System (A to D)
- Assess symptom burden using questionnaires
- Modified Medical Research Council (mMRC): Measures degree of dyspnea
- COPD Assessment Test (CAT): Assesses overall impairment of health in COPD
- Record exacerbation risk: Based on number and severity of prior exacerbations
Group System Algorithm for Combined COPD Assessment
- 0 or 1 exacerbation not leading to hospitalization
- Group A: mMRC 0 to 1 | CAT <10
- Group B: mMRC ≥2 | CAT ≥10
- ≥2 exacerbations or ≥1 exacerbation leading to hospitalization
- Group C: mMRC 0 to 1 | CAT <10
- Group D: mMRC ≥2 | CAT ≥10
Pharmacologic Therapies
Bronchodilators: B2-agonists or Anti-Muscarinics
- B2-agonists
- Classified as short-acting (SABA) or long-acting (LABA)
- Anti-muscarinics
- Long-acting formulations (LAMA) used for stable COPD (short-acting generally reserved for exacerbations)
Inhaled Corticosteroids (ICS)
- Primary benefit is preventing exacerbations
- Prescribed in combination with LABA
- Greatest benefit: Blood eosinophils > 300 cells/mL
- Long-term monotherapy not recommended due to risk for pneumonia, oral thrush, and vocal hoarseness
- No benefit of long-term oral glucocorticoids for stable COPD
GOLD group-Based Initial Treatment Recommendations at Time of Diagnosis
- GOLD A
- SABA or LABA
- GOLD B
- LABA or LAMA
- GOLD C
- LAMA
- GOLD D
- LAMA
- If highly symptomatic (e.g., CAT >20): LAMA and LABA
- Blood eosinophils > 300 cells/mL: ICS and LABA
Follow-up Pharmacotherapy
- If therapy needs to be escalated, first identify if primary issue is persistent dyspnea or frequent exacerbations | Follow exacerbation pathway if both dyspnea and frequent exacerbations are present
For Persistent Dyspnea
- Add second bronchodilator (LABA or LAMA)
- If already on LABA/ICS, add LAMA (or replace ICS with LAMA)
- Consider other causes of dyspnea (e.g. heart failure, anemia)
For Frequent Exacerbations
- Add second bronchodilator or ICS
- If already on LABA/LAMA
- Blood eosinophils ≥ 100 cells/mL: Escalate to triple therapy (LABA/LAMA/ICS)
- Blood eosinophils < 100 cells/mL: Add roflumilast (for FEV1 < 50% predicted and chronic bronchitis) or azithromycin (for former smokers) | If already on LABA/ICS: Escalate to triple therapy (LABA/LAMA/ICS)
- Consider de-escalation of ICS if
- Pneumonia
- Inappropriate original indication
- Lack of response
Adjunctive Therapies
- Smoking cessation (counseling and pharmacotherapy; see ATS guidelines)
- Vaccination (influenza and pneumococcal)
- Ensure proper inhaler technique
- Pulmonary rehabilitation for GOLD groups B through D
Indications for Chronic Oxygen Therapy
- PaO2 ≤55 mmHg or SaO2 ≤88% +/-hypercapnia (measured twice over 3 weeks)
- PaO2 55 to 60 mmHg if presence of pulmonary hypertension, congestive heart failure, or polycythemia
- Oxygen goal: Titrate to SaO2 ≥90%
- CPAP or BIPAP
- Long-term non-invasive ventilation may be indicated for patients with severe daytime hypercapnia
- CPAP recommended for patients with comorbid obstructive sleep apnea
Surgical Intervention
- Specific subsets of patients may be eligible for bullectomy, lung volume reduction surgery, or lung transplant
- Palliative and hospice care should be available for patients with advanced or treatment-resistant symptoms
Differential Diagnosis
- Asthma | Congestive Heart Failure | Bronchiectasis | Tuberculosis | Obliterative Bronchiolitis | Diffuse Bronchiolitis
Primary Sources – Learn More:
mMRC (Modified Medical Research Council) Dyspnea Scale
Cerebrovascular Accident (CVA) and Stroke: Acute Management
SUMMARY:
Cerebrovascular accident, or stroke, represents acute disruption of cerebral perfusion. There are two categories of stroke, ischemic and hemorrhagic. Ischemic stroke (70% of all stroke) is when there is disruption of the vascular supply of the brain, be it by vascular occlusion or obliteration, with downstream ischemia. Hemorrhagic stroke (30% of all stroke) represents bleeding into the skull, which is further subdivided depending on the location of the bleeding. Below is a summary of guidelines that detail pre-hospital care, urgent and emergency evaluation, treatment with intravenous and intra-arterial therapies. Generally speaking, time is brain, and so emergent evaluation is highly recommended in the hyperacute/acute setting.In-hospital management is also covered, including secondary prevention measures that are appropriately instituted within the first 2 weeks.
Categorization of Stroke Types
Ischemic Stroke
- Vascular disruption with subsequent prevention of cerebral perfusion
- Thrombotic: The clot is formed at the site of vascular occlusion
- Embolic: The thrombus travels to the brain (often from the heart)
- Small vessel: obliteration of penetrating arteriole (arteriosclerosis)
- Systemic Hypoperfusion (often in the setting of profound hypotension, or prolonged CPR)
Hemorrhagic Stroke
- Blood vessel ruptures and impairs circulation
- Intracerebral: Small arteries in the brain tissue
- Subarachnoid: Usually due to outpouchings or aneurysms of the vessels that eventually rupture into the lining around the brain
- Subdural: often seen because of trauma, where blood accumulates outside the brain, but below the dura
- Epidural: often seen in direct trauma to the side of the head, disruption of the middle meningeal artery
Transient Ischemic Attack (TIA)
- Clinical definition
- Symptoms of stroke | Ischemic in nature | Present and resolve within 24 hours
- While many patients may symptomatically resolve, magnetic resonance imaging (MRI) may reveal imaging findings consistent with acute ischemia in a substantial fraction, thereby changing the diagnosis to acute stroke
- Evaluate Emergently for further risk stratification and implement secondary prevention measures implemented
- TIA is felt to be the precursor of stroke, with many who suffer from a TIA at high risk of having a stroke within the next two weeks
- Symptomatically there is no difference between ischemic stroke and TIA in the hyperacute setting
Symptoms
- Trouble speaking or difficultly with comprehension (expressive or receptive aphasia)
- Speech may be incomprehensible or garbled
- Paralysis or numbness
- Usually presents with hemiparesis
- Visual disturbances
- May experience blurred or loss of all sight in one or both eyes
- Usually in combination with the other symptoms, but sometimes can be found in isolation
- Headache due to increased intracranial pressure (more likely with hemorrhagic stroke)
- Often the worst headache experienced in a patient’s life or “thunderclap” in nature
- Associated with vomiting, dizziness, or altered level of consciousness
- Difficulty with walking or balance
- Patients may develop dizziness and/or a loss of balance or coordination
Risk Factors
Modifiable Risk Factors
- Hypertension: Most common cause of stroke
- Tobacco abuse
- Diabetes mellitus
- Stimulant use
- Antithrombotics (for hemorrhagic stroke)
- Previous CVAs or TIAs
- Strenuous activity in patients who have family history or risk factor for aneurysms
- Sedentary lifestyle
- Excessive alcohol use
- Obesity
- High Cholesterol or triglycerides
Nonmodifiable Risk Factors
- Age: Risk increase with age, especially over the age of 60
- Male sex: More common in younger ages in men
- Race & ethnicity: African Americans & Hispanic Americans are at higher risk
Differential Diagnosis
- Brain tumors
- Brain abscesses
- Seizure
- Complex migraine
- Multiple Sclerosis
- Acute Disseminated Encephalomyelitis (ADEM)
Treatment: Ischemic Stroke
Medications
- Alteplase/Tenecteplase
- Thrombolytic mechanism of action increases the chances of cerebral perfusion, which often improves neurological deficits
- Must be given within 3 hours of symptom onset
- Certain patients are candidates for an extended 4.5 hour window
- The major risk is hemorrhagic stroke (~3% risk for alteplase)
- Dual Antiplatelet Therapy | Start within 24 hours of symptom onset
- Ischemic stroke from intracranial atherosclerosis: Aspirin (160 to 325 mg loading dose, followed by 50 to 100 mg daily) plus clopidogrel (600 mg loading dose followed by 75 mg daily) for 21 to 90 days, followed by monotherapy indefinitely
- TIA or minor stroke: Aspirin plus clopidogrel for 21 to 30 days with the same dosing as above
Note: Aspirin plus clopidogrel is more effective than aspirin but less effective than anticoagulation for preventing stroke from atrial fibrillation
- Anticoagulant prophylaxis for inpatient use
- Lovenox | Heparin | Xarelto | Eliquis | Pradaxa
- Ensure any medication is adjusted for abnormal renal function
- Outpatient use of anticoagulants is only for treatment of atrial fibrillation
Blood Pressure Control
- Ischemic stroke treated with TPA: Treat BP if exceeds >185/>105
- Ischemic stroke without TPA: Allow for permissive hypertension and treat only if >220/>120 if no other comorbidities require normotension (weak evidence) | May be reasonable to lower by 15% in the first 24 hours
Surgery
- Mechanical thrombectomy can be offered at certain stroke centers within 24 hour time window, depending on patient deficits and the size of the occlusion
Treat Other Comorbidities
- Atrial fibrillation
- Hypertension
- Diabetes Mellitus
- High Cholesterol or Triglycerides
Treatment: Hemorrhagic Stroke
Medications
- Mainstay of treatment is blood pressure medications to maintain BP <140/<90
Surgery
- Ruptured aneurysm may require clips or stents to prevent further bleeding
Tests and Imaging
Diagnostic Neuroimaging
- Emergent non-contrast head computed tomography to identify hemorrhagic stroke
- Follow-up Multimodal CT or magnetic resonance imaging
- Diffusion weighted MRI is more sensitive than CT for acute ischemic stroke
Additional Tests
- Complete blood count and electrolyte panel with glucose
- Electrocardiogram
- Lipid panel
Complications
- Cerebral edema
- Pneumonia
- Urinary tract infection (UTI) / Loss of bladder control
- Seizures
- Depression
- Bedsores
- Limb contractures
- Shoulder pain
- Deep venous thrombosis (DVT)
Learn More – Primary Sources:
Use of Dual Antiplatelet Therapy Following Ischemic Stroke (Dong et al, Stroke 2020)
Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA (Johnston et al, NEJM 2018)
Cellulitis: Clinical Presentation, Differential Diagnosis and Treatment
Summary:
Cellulitis is an infection of the soft tissue deep to the skin that results in erythema, inflammation, tenderness, and pain. It is most commonly caused by Streptococcus pyogenes or staphylococcus aureus. Other etiology bacteria include haemophilus influenza, streptococcus pneumonia, gram negative, and anaerobic species. The treatment is with antibiotics targeted at the suspected etiologic organism. Cephalexin is standard for non-purulent cellulitis, with coverage for methicillin-resistant staphylococcus aureus being necessary in the setting of purulence. Duration and intravenous (IV) versus oral anti- microbial therapy is dependent on the clinical severity
Microbiology
- Beta-hemolytic streptococcus species
- Staphylococcus aureus
- Most common organism in abscesses with the exception or perioral or perirectal locations
- Large burden of methicillin-resistance Staphylococcus aureus (MRSA)
- Specific situations
- Pasteurella multocida in the setting of animal bites
- Aeromonas hydrophila and Vibro vulnificus in water exposure
- Clostridium species in gas gangrene
Clinical Presentation
- Presents as a local area of erythema(less obvious on hyperpigmented skin tones), warmth, tenderness, and pain
- May be patchy
- Typically unilateral
- Lower extremities are the most common location
- Skin should be inspected for areas of breakdown, including maceration
- Other predisposing conditions include lymphedema, venous insufficiency, immunocompromise, tinea infections
Risk Factors & Transmission
- Any skin disruption, such as tinea, ulcers, or wounds
- Prior cellulitis
- Venous insufficiency or impaired lymphatic drainage
- Chronic edema
- Obesity
- Injection drug use
Differential Diagnosis
- Erysipelas | Has sharply demarcated and raised borders
- Necrotizing fasciitis
- Gas gangrene
- Varicella zoster
- Stasis dermatitis
- Typically both lower legs unlike unilateral presentation in cellulitis
- Septic arthritis or bursitis
- Consider if located near a relevant structure
- Gout
- Consider if clearly inflamed joint or a prior history of similar symptoms
- Insect bite
- Some bites can be associated with large local reactions, e.g., Lyme disease (without typical ‘bullseye’ pattern)
- Outdoor activity or unusual location for cellulitis may point to Lyme
Diagnosis
- Clinical diagnosis suspected when there is an appropriate history and physical exam
- Identify if any abscess is present either clinically or with ultrasound
Treatment
- Incise and drain any detectible abscess
- Culture any abscess, although deferral is reasonable in a typical case
- Skin cultures of non-purulent cellulitis are not recommended
- Mark the leading edge of erythema
Antibiotic choice depends on location of care and suspected etiologic agent (see below)
- Location of care
- Admission is indicated for systemic signs, intractable pain, suspicion of deep space infection, immunocompromise, or failed outpatient treatment
- Admission requires intravenous antibiotics and blood cultures are recommended
- Transition to an appropriate oral agent may occur after clinical improvement
- Etiologic agent
- Purulent infections must consider agent active against MRSA
- Perirectal, perioral, or pressure ulcers require MRSA, gram-negative, and anaerobic coverage pending culture results
- If cellulitis associated with penetrating trauma or if evidence of MRSA infection elsewhere, nasal colonization with MRSA, injection drug use, or systemic inflammatory response syndrome; coverage against both MRSA and streptococci recommended
- See below for antibiotic choices
Duration
- Uncomplicated cellulitis: 5 days of therapy is sufficient if clinical improvement has occurred
- Admitted patients: Up to 14 days may be required depending on clinical course
Antibiotics list
Purulent infection, with or without abscess (MRSA coverage needed)
- Oral agents
- Trimethoprim-Sulfamethoxazole 1-2 double-strength tablets BID
- Doxycycline 100 mg BID
- Clindamycin 300-450 mg QID
- Intravenous agents
- Vancomycin dosed per hospital protocol
- Linezolid 600 mg every 12 hours
- Daptomycin 4 mg/kg every 24 hours
Non-purulent infection (coverage for MRSA considered if risk factors)
- Oral agents
- Cephalexin 500 mg QID
- Dicloxacillin 500 mg QID
- Clindamycin 300-450 mg QID
- Trimethoprim-Sulfamethoxazole 1-2 double-strength tablets BID
- Intravenous agents
- Cefazolin 1 g every 8 hours
- Nafcillin or oxacillin 1 g every 8 hours
- Clindamycin 600 mg every 8 hours
Learn More – Primary Sources
NICE Guideline: Cellulitis and erysipelas: antimicrobial prescribing (2019)
Asthma: Diagnosis and Classification
CLINICAL ACTIONS:
Asthma is a common lung disorder in which inflammation causes the bronchi to swell and narrow the airways (bronchospasm), causing reversible, recurrent airway obstruction. History and physical are important, not only for making the diagnosis but also to help guide classification which is essential for the management plan. Spirometry should be used in all patients >5 years of age to determine that airway obstruction is at least partially reversible.
History: Key Elements
- Wheezing
- Shortness of breath
- Difficulty breathing
- Chest tightness
- Coughing: Note associated timing
- At night
- During exercise
- When laughing or crying
- Symptoms may interfere with normal activities
- Ask about aggravating environmental factors such as
- Viral infection
- Animals with fur or hair
- Mold
- Smoking
- Pollen
- Menstrual cycle
Physical Exam
- Auscultation: Listen for the following especially when exhaling
- Wheezing
- Whistling
- Other clinical findings: Include assessment of the following
- ENT: Ears, nose, throat for swelling, drainage due to allergy and/or inflammation
- Chest: Hyper expansion of thorax (especially children)
- Skin and eyes: Atopic dermatitis | Eczema | Evidence of allergic condition
Pulmonary Function Tests
Spirometry
- Test used for both diagnosis and monitoring
- Normal score: ≥80 % of predicted value
- Tests the forced expiratory volume of air that can be exhaled during forced breath
- FEV1 (forced expiratory volume): Volume exhaled in the first second
- FVC (forced vital capacity): Total volume exhaled after a deep breath
- FEV1/FVC ratio: When FEV1 <80% of FVC, suspicious for obstructive rather than restrictive lung disease (more likely to decrease proportionally)
- If FEV1 ≥12% after bronchodilator challenge indicative of reversible airway obstruction
- Tests the forced expiratory volume of air that can be exhaled during forced breath
Fractional Exhaled Nitric Oxide (FeNO)
- FeNO testing measures the nitric oxide, a byproduct of inflammation, in exhaled breath
- May be useful in diagnosing, managing and predicting future exacerbations in some types of asthma
- May be used as an adjunct to the evaluation process
Notes: FEV6 (volume after 6 seconds) can be considered rather than FVC in adults for whom full exhalation may take several seconds and be associated with light headedness | There are contraindications to spirometry (e.g., unstable cardiac disease or recent MI, aneurysms, recent thoracic or abdominal surgery, active viral infection, unexplained hypertension) | pre and post bronchodilator testing may be done in pulmonologist practice
Allergy Testing for precipitating factors
- Consider referral for allergy testing if possibility that patient has allergies which may precipitate asthma (e.g., cats, dogs, medications)
Chest X-Ray: Key Findings
- Typically, won’t show any abnormality
- Important for assessment of other causes of respiratory disease, or other causes of exacerbation and/or worsening symptoms (e.g., pneumonia | foreign body in airways)
SYNOPSIS:
While targeted questions and examination are helpful, a good overall history and physical remain important to identify co-morbidities (e.g., sinusitis, rhinitis, GERD, other respiratory disorders, obstructive sleep apnea). It is also important to remain cognizant that multiple external factors can trigger an attack, including respiratory infections, smoking, allergies, exposure to cold or humid air, pollution, exercise, severe emotional and/or physical stress. Spirometry is currently the primary diagnostic tool for asthma.
KEY POINTS:
Severity of Asthma
- Asthma severity is determined by the following
- Reported symptoms over the previous two to four weeks
- Standardized
questionnaires – e.g., the Asthma Control Test
- Provides numerical score to determine if the symptoms are well controlled
- Current level of lung function: PEFR | FEV1 | FEV1/FVC
- Number of exacerbations requiring oral glucocorticoids in the previous year
Types of Asthma
Intermittent
- No interference with normal activities between exacerbations
- Daytime asthma symptoms: ≤2 days per week
- Nocturnal awakenings: ≤2 per month
- Use of short-acting beta agonists to relieve symptoms: ≤2 days per week
- FEV1 between exacerbations: Within normal range (i.e., ≥80 percent of predicted)
- FEV1/FVC ratio between exacerbations: Within normal range (based on age-adjusted values)
- Oral glucocorticoids requirements: ≤1 exacerbation per year
- Other circumstances
- Use of Short-Acting Beta Agonists (SABAs) to prevent exercise-induced asthmatic symptoms (even if exercising more than twice per week)
- Infrequent circumstances: Exposures such as cat encounter or URTI
Mild persistent
- Minor interference with normal activities
- Symptoms: >2 weekly (not daily)
- Nocturnal awakenings: 3 to 4 per month (not every week)
- Use of SABAs: > 2 days per week (Not daily)
- FEV1: between exacerbations: Within normal range (≥80 percent of predicted)
- FEV1/FVC ratio between exacerbations: Within normal range (based on age-adjusted values)
- Oral glucocorticoids requirements: ≥2 exacerbations per year
Moderate persistent
- Daily symptoms of asthma
- Some limitation in normal activity
- Nocturnal awakenings: ≥1 per week
- Need for SABAs: Daily
- FEV1: 60 to 80 percent predicted
- FEV1/FVC: Below normal
Severe persistent
- Symptoms of asthma throughout the day
- Extreme limitation in normal activity
- Nocturnal awakenings: Nightly
- Need for SABAs: Several times per day
- FEV1: <60 percent of predicted
- FEV1/FVC: Below normal
When to refer to pulmonologist and/or allergist/ immunologist
- Life-threatening asthma exacerbation
- >2 bursts of oral glucocorticoids in a year
- Asthma not controlled after three to six months of active therapy and appropriate monitoring
- Unresponsive to therapy
- Diagnosis of asthma is uncertain
- Comorbid conditions that
are complicating management such as
- Nasal polyposis | Chronic sinusitis | Severe rhinitis | Allergic bronchopulmonary aspergillosis (see review below in ‘Learn More – Primary Sources), COPD, vocal cord dysfunction
- Additional diagnostic
tests are needed such as
- Skin testing for allergies | Bronchoscopy | Complete pulmonary function tests
- Potential candidate for allergen immunotherapy
Learn More – Primary Sources
2020 Focused Updates to the Asthma Management Guidelines | NHLBI, NIH
CDC: Asthma Resources for Healthcare Professionals
American Thoracic Society: Asthma Center
Diagnosing Allergic Bronchopulmonary Aspergillosis: A Review
Asthma: The Stepwise Approach to Treatment
Table of Contents
CLINICAL ACTIONS:
Because asthma is an inherently variable condition, therapy should be reassessed at each visit. Management is a dynamic process that will change based on the patient’s needs over time.
- Effective asthma management requires a proactive, preventative and stepwise approach
- Control of asthma is viewed in the context of impairment and risk
Reducing Impairment
Optimize care by focusing on the following
- Symptom prevention: Minimize troublesome coughing or breathlessness in the daytime, during the night, or after exertion
- Infrequent use of quick-acting inhaled beta-2-selective adrenergic agonists (SABAs): ≤2days a week for quick relief of symptoms
- Maintain (near) normal pulmonary function
- Maintain normal activity levels including
- Exercise and other physical activity
- Attendance at work or school
Reducing Risk
Use ASTHMA ACTION PLAN (see ‘Learn More – Primary Sources’ below) or other management plan to
- Prevent recurrent exacerbations
- Minimize the need for ED visits or hospitalizations
- Prevent progressive loss of lung function
- Provide optimal pharmacotherapy with minimal or no adverse effects
SYNOPSIS:
The Expert Panel recommendations specify that treatment must be individualized in a ‘stepwise’ fashion. The guidelines note that “The stepwise approach is meant to help, not replace, the clinical decision making needed to meet individual patient needs.” If a patient remains stable for at 3 months, reducing medications in a ‘step down’ approach can be used. In addition, two key factors to a successful outcome are patient education and measures to control environmental triggers and comorbidities.
KEY POINTS:
Treatment
Intermittent Asthma
Step 1
- Recommendation: SABAs taken as needed for relief of symptoms
- Daily scheduled chronic use of SABA is not recommended
- If SABA >2 days a week for symptom relief: Inadequate control and consider next category (mild persistent asthma) and use of anti-inflammatory therapy
- SABAs
- Albuterol | Levalbuterol | Pirbuterol
- 2 puffs q4 to 6 hours | 2 puffs 5 minutes before exercise
- SABA in fluid form can be used for acute asthma attacks via nebulizer (breathing machine)
- Works via acute bronchodilation
- Potential side effects
- Systemic: Tachycardia | Skeletal muscle tremor | Hypokalemia | Increased lactic acid | Headache | Hyperglycemia
- Inhaled: Few systemic effects in otherwise healthy individuals; however, those with preexisting CVD (especially elderly) may have adverse CVD reaction
- Albuterol | Levalbuterol | Pirbuterol
- Exercised-Induced Bronchoconstriction (EIB): Patients with triggering of asthmatic symptoms which can be predicted (e.g., EIB) advised to use their inhaled beta agonist approximately 10 minutes prior to exposure in order to prevent the onset of symptoms
- Cromolyn or nedocromil can also be used for EIB
Persistent Asthma
Step 2
Note: Before moving on to next steps, review the following: Patient’s inhaler technique | Therapy adherence | Precipitating or aggravating factors such as allergens or comorbid conditions
- Recommendation (Preferred): Daily low-dose inhaled glucocorticoid (ICS) single agent with as needed SABA or ICS and SABA used concomitantly as needed
- Reduces frequency of symptoms
- Reduces the need for SABAs for symptom relief
- Improves the overall quality of life
- Decreases the risk of serious exacerbations
- Works via anti-inflammatory effect
- ICSs
- Beclomethasone dipropionate | Budesonide | Flunisolide | Fluticasone propionate | Mometasone furoate | Triamcinolone acetonide
- Alternative strategies (not preferred)
- Daily leukotriene receptor antagonists (LTRAs: montelukast and zafirlukast) and as needed SABA or
- Cromolyn, or Nedocromil, or Zileuton or Theophylline, and as needed SABA
- Patient with seasonal asthma (related to seasonal molds or pollens) should be considered as having
- Persistent asthma during the season
- Intermittent asthma remainder of the year
Step 3
- Recommendation (Preferred): Daily and as needed combination low-dose ICS-formoterol
- Alternative (not preferred)
- Daily medium-dose ICS and as needed SABA or
- Daily low-dose ICS-LABA, or daily low-dose ICS + LAMA (long-acting muscarinic antagonist), or daily low-dose ICS + LTRA, and as needed SABA or
- Daily low-dose ICS + Theophylline or Zileuton, and as needed SABA
Note: For Steps 2 to 4, the guideline conditionally recommends the use of subcutaneous immunotherapy as an adjunct treatment to standard pharmacotherapy in individuals ≥5 years of age whose asthma is controlled at the initiation, build up and maintenance phases of immunotherapy
Step 4
- Recommendation (Preferred): Daily and as needed combination medium-dose ICS-formoterol
- Alternative (not preferred)
- Daily medium-dose ICS-LABA or daily medium dose ICS + LAMA and as needed SABA or
- Daily medium-dose ICS + LTRA, or daily medium-dose ICS + Theophylline, or daily medium-dose ICS + Zileuton, and as needed SABA
Step 5
- Recommendation (Preferred): Daily medium-high dose ICS-LABA + LAMA and as needed SABA
- Alternative (not preferred)
- Daily medium-high dose ICS-LABA or daily high-dose ICS + LTRA, and as needed SABA
Step 6
- • Daily high-dose ICS-LABA + oral systemic corticosteroids + as needed SABA
- Use lowest dose to start on a daily or alternate-day regimen
Note: For Steps 5 and 6 consider adding Asthma Biologics (e.g. anti-IgE, anti-IL5, anti-IL5R, anti-IL4/IL13)
Referral To Asthma Specialist
- Refer to asthma specialist for consultation or comanagement for the following indications
- Difficulty achieving or maintaining asthma control
- Immunotherapy is being considered
- Omalizumab is being considered
- Patient requires step 4 care or higher
- Exacerbation requiring hospitalization
- Consider referral if patient requires step 3 care
Managing Acute Exacerbations Requiring Emergency Care
- Oxygen to relieve hypoxemia in moderate or severe exacerbations
- SABA to relieve airflow obstruction
- Add inhaled ipratropium bromide if severe
- Add systemic corticosteroids to decrease airway
inflammation
- If moderate or severe exacerbation or
- If patient doesn’t respond promptly and completely to a SABA
- If severe and not responding to above, consider
- Adjunct treatments such as IV magnesium sulfate or heliox
- Monitoring: Serial measurements of lung function
- Prevent relapse
- Referral to follow up asthma care within 1–4 weeks
- ED asthma discharge plan that includes
- Medication review
- Instructions on how to increase medications or seek care if symptoms worsen
- During follow up visits
- Review Inhaler techniques
- Consider ICSs
Monitoring
- At each visit review the following
- Asthma control
- Asthma action plan
- Compliance with medications
- Stay alert once symptoms are controlled as some patients may “skip” meds, sometimes due to lack of financial resources
- Medication technique
- Check peak flow
Peak flow
- PEF (Peak Expiratory Flow) | PEFR
(Peak Expiratory Flow Rate)
- Measures the rate of air at which patient can force air out
- “It must be stressed that peak flow meters function best as tools for ongoing monitoring, not diagnosis” (Expert Panel Report)
- Sensitive to airway changes such as narrowing even prior to manifestation of asthmatic symptoms
- Use ‘personal best’ peak flow as reference value
- ‘Normal’ value varies by gender, age
and height
- Green zone 80-100 % of personal best: OK
- Yellow zone 50-80 % of personal best: Take quick relief medication | May need increase dose or change
- Red zone <50 %: Call physician or go to ER
Spirometry
- Spirometry is recommended at the time of initial assessment for diagnostic purposes, but is also used for monitoring
- After treatment is initiated and symptoms and PEFs have stabilized
- During periods of progressive or prolonged loss of asthma control
- At least every 1–2 years
Schedule follow up visits
- Every 2–6 weeks while gaining control
- Every 1–6 months to monitor control
- Every 3 months if step down in therapy is anticipated
- Expert Panel recommends that the dose of ICS may be reduced about 25–50 percent every 3 months to the lowest dose possible that is required to maintain control
Treat comorbid conditions and assess vaccination status
- Inactivated flu vaccine yearly
- CDC also recommends
- Pneumococcal vaccine PPSV23
- 19 to 64 years: 1 dose
- ≥65 years: One final dose at least five years following previous dose
- Zoster vaccine
- Tdap vaccine
- Pneumococcal vaccine PPSV23
Pregnancy
- Check asthma control at all prenatal visits and adjust medications as needed
- Treatment safer for both mother and fetus vs uncontrolled asthma
- Avoid exposure to tobacco smoke
Learn More – Primary Sources:
Asthma Management Guidelines: Focused Updates 2020
CDC: Asthma Resources for Healthcare Professionals
American Thoracic Society: Asthma Center
NHLBI: Asthma Care Quick Reference – Diagnosing and Managing Asthma
CDC: Lung Disease including Asthma and Adult Vaccination
American Thoracic Society: Initiating Pharmacologic Treatment in Tobacco-Dependent Adults
SUMMARY:
All patients who use tobacco should be provided with treatment to help them quit. The American Thoracic Society (ATS) has released guidance on pharmacotherapy for tobacco cessation and state that simply advising patients to quit is insufficient. ATS is the first organization to recommend varenicline (Chantix) as first-line therapy for cessation. The guidelines also address combination pharmacotherapy, starting medication for patients who are not yet ready to quit, and treating tobacco users with comorbid psychiatric disease.
ATS Smoking Cessation Recommendations
Varenicline over other pharmacotherapy (bupropion) or nicotine replacement therapy (nicotine patch)
- Varenicline superior for achieving long-term abstinence
- Generally assessed by patient self-report +/- exhaled carbon monoxide testing
- Varenicline associated with fewer serious adverse events (SAEs) vs nicotine patch
- No difference in SAEs compared to bupropion
Varenicline plus a nicotine patch over varenicline alone (conditional recommendation)
- Combination therapy significantly increases abstinence
- Conditional recommendation based on
- Anticipated issues with patient adherence | Cost | Possible increased incidence of SAEs
Start varenicline even for patients who are not yet ready to quit tobacco
- Significant effect on abstinence even in active smokers
- “Pharmacotherapy is no longer contingent on readiness to quit but is instead a therapeutic intervention aimed at improving readiness to stop smoking”
Start varenicline even for patients with comorbid psychiatric disease (substance use disorder, depression/anxiety, schizophrenia, bipolar disorder)
- Stigma around varenicline use in this population due to former boxed warning regarding possible neuropsychiatric events (based on case reports, not supported by RCTs)
Extended duration (>12 weeks) therapy over standard duration (6-12 weeks) for any cessation aid (varenicline, bupropion or nicotine patch)
- Extended therapy results in increased abstinence with less relapse
Dosing Varenicline
Initial: Days 1 to 3: 0.5 mg once daily | Days 4 to 7: 0.5 mg twice daily
Maintenance (day 8 and later): 1 mg twice daily continued for at least 11 weeks
Note: Dosing should be adjusted for renal function, see references below
References:
CDC Vaccination Schedule: Birth – 18 years
We are pleased to bring you the CDC vaccination schedule, from birth to 18 years of age. Click here to see the adult schedule
Note that on certain mobile devices, you will need to scroll horizontally to see Tables in their entirety. Details on individual disorders and vaccines appear at the bottom of the Tables. Another option is to tap the ‘compliant version’ link. The PDF icons below will also take you to the current schedules and information and can be saved to your device.
Trichomoniasis: CDC Diagnosis and Treatment Guidelines
SYNOPSIS:
Trichomoniasis is the most prevalent nonviral sexually transmitted infection worldwide. The U.S. population-based T. vaginalis prevalence is 2.1% among females and 0.5% among males, with the highest rates among Black females (9.6%) and Black males (3.6%), compared with non-Hispanic White women (0.8%) and Hispanic women (1.4%) The majority of persons who have trichomoniasis (70%–85%) either have minimal or no genital symptoms, and untreated infections might last from months to years, however, data are lacking on whether screening and treatment for asymptomatic trichomoniasis is beneficial. Decisions about screening might be informed by local epidemiology of T. vaginalis infection rates.
CLINICAL ACTIONS:
Male: Urethritis| Epididymitis | Prostatitis
Women: Vaginal Discharge| Vulvar Irritation
Diagnostic testing for T. vaginalis should be performed in women seeking care for vaginal discharge (yellow-green, with or without irritation). Screening might be considered for women receiving care in high-prevalence settings.
Diagnosis
- Perform nucleic acid amplification testing (NAAT), which detects T. vaginalis genetic material, is highly sensitive and which is three to five times more likely to identify T. vaginalis infections than wet-mount microscopy, a method with poor sensitivity
- Culture was considered the gold standard before molecular testing and is less sensitive than newer tests
- If wet preparations are used, despite lower sensitivities, slides should be evaluated immediately as sensitivity declines with time
- If negative, consider follow up with a NAAT to make sure infection is truly not present
- T. vaginalis may be an incidental finding on a Pap test, neither conventional nor liquid-based Pap tests are considered diagnostic tests for Trichomoniasis, because false negatives and false positives can occur
KEY POINTS:
The nitroimidazoles are the only class of antimicrobial medications known to be effective against T. vaginalis infections. Of these drugs, metronidazole and tinidazole have been cleared by FDA for the oral or parenteral treatment of trichomoniasis.
The CDC recommends the following
- Women
- Metronidazole 500 mg 2 times/day for 7 days
- Men
- Metronidazole 2 g orally in a single dose
- Alternative regimen for men and women
- Tinidazole 2 g orally in a single dose
Note: ACOG also recommends metronidazole 500 mg orally twice a day for 7 days as the recommended treatment option with tinidazole, 2 g orally in a single dose as the alternative regimen
- Alcohol consumption should be avoided during treatment with nitroimidazoles
- To reduce the possibility of a disulfiram-like reaction, abstinence from alcohol use should continue for 24 hours after completion of metronidazole or 72 hours after completion of tinidazole
- Providers should advise persons infected with T. vaginalis to abstain from sex until they and their sex partners are treated (i.e., when therapy has been completed and any symptoms have resolved)
- Testing for other STDs including HIV should be performed in persons infected with T. vaginalis
- Retest for T. vaginalis is recommended for all sexually active women within 3 months following initial treatment
- Testing by NAAT can be conducted as soon as 2 weeks after treatment
- Treat current partners to avoid reinfection and further transmission
- Partners should be advised to abstain from intercourse until they and their sex partners have been adequately treated and any symptoms have resolved
- In States where legally allowed (see Learn More below), consider Expedited Partner Therapy (EPT) which allows the patient herself to provide medications to her partner when there are limited public health services to treat a partner, or concern that the partner will not have access to treatment
Pregnancy
- T. vaginalis infection is associated with two to threefold increased risk for HIV acquisition, preterm birth, and other adverse pregnancy outcomes among pregnant women
- However, some trials have not shown improvement in perinatal morbidity with treatment
- Symptomatic pregnant women, regardless of pregnancy stage, should be tested and considered for treatment with metronidazole
- Tinidazole should be avoided for pregnant women
- The benefit of routine screening for T. vaginalis in asymptomatic pregnant women has not been established
HIV
- Among women with HIV infection, up to 53% are also infected with T. vaginalis which has been associated with an increased risk for PID
- Routine screening of asymptomatic women with HIV infection for T. vaginalis is recommended on entry to care, and then annually
- Pregnant women, including those who are asymptomatic, should be screened and treated as necessary because T. vaginalis infection is a risk factor for vertical HIV transmission
- The recommended regimen in the setting of HIV is as follows
- Metronidazole 500 mg twice daily for 7 days
- Retest in 3 months with NAAT
Learn More – Primary Sources:
CDC: Trichomoniasis Treatment Guidelines
CDC: Trichomoniasis Fact Sheet for Your Patients
CDC: Expedited Partner Therapy
ACOG Practice Bulletin 215: Vaginitis in Nonpregnant Patients
Syphilis: CDC Diagnosis and Treatment Guidelines
WHAT IS IT?
Syphilis is a sexually transmitted infection caused by Treponema pallidum. Symptoms, diagnostic tests and treatment vary depending on stage of the disease. Rates of syphilis have been increasing over the past 20 years. Without treatment, syphilis can damage the brain, nerves, eyes, and cardiovascular system.
Screening for Syphilis
Who to Screen
- The USPSTF task force recommends screening for the following populations (Grade A recommendation: “Offer or provide this service”)
- Asymptomatic, nonpregnant adolescents and adults who are at increased risk for syphilis infection
- All pregnant women early in pregnancy
- Factors associated with increased risk for syphilis include
- Higher prevalence of infection in particular communities
- Sociodemographic and behavioral factors (e.g., multiple sex partners, prevalence of syphilis is higher in males, men who have sex with men, drug use, persons living with HIV, young adults, and persons with a history of incarceration, sex work, or military service)
How to Screen
- Traditional screening: Initial “nontreponemal” antibody test (i.e., Venereal Disease Research Laboratory [VDRL] test or rapid plasma reagin [RPR] test) to detect biomarkers released from damage caused by syphilis infection, followed by a confirmatory “treponemal” antibody detection test (i.e., fluorescent treponemal antibody absorption [FTA-ABS] or T pallidum particle agglutination test [TP-PA])
- Reverse sequence screening algorithm: Automated treponemal test (such as an enzyme-linked [EIA], chemiluminescence [CIA], or multiplex flow immunoassay [immunoblot]) performed first, followed by a nontreponemal test
- If the test results of the reverse sequence algorithm are discordant, a second treponemal test (preferably using a different treponemal antibody) is performed
Primary Syphilis
Early disease, characterized by an ulcer or chancre at the infection site approximately 3 weeks after infection
- Diagnosis
- Darkfield examination and molecular tests of fluid/tissue for T. pallidum are definitive methods or
- Presumptive diagnosis requires both a (1) nontreponemal test (VDRL or RPR) and (2) a treponemal test (FTA-ABS, EIA, CIAs and immunoblots, rapid treponemal tests or TP-PA)
- Treatment
- Benzathine penicillin G 2.4 million units IM in a single dose
Secondary Syphilis
Symptoms can be diffuse and variable
- Symptoms
- Skin rash (classically with involvement of palms and soles) | Mucocutaneous lesions | Lymphadenopathyn | Fever | Alopecia | Ocular symptoms | Headache | Hepatitis
- Typically develops several weeks to months after primary infection
- Diagnosis
- Same as for primary syphilis
- Treatment
- Same as for primary syphilis
Latent Syphilis
No symptoms and no current evidence of primary, secondary, or tertiary disease
- Diagnosis of early latent syphilis
- Documented seroconversion or sustained ( >2 weeks) fourfold or greater increase in nontreponemal test or unequivocal symptoms of primary/secondary syphilis or a sex partner with documented primary/secondary syphilis all within the past year
- Treatment
- Early latent (acquired within 1 yr): Benzathine penicillin G 2.4 million units IM single dose
- Late latent (acquired > 1 yr): Benzathine penicillin G 7.2 million units total given IM in 3 weekly doses of 2.4 million units each
Tertiary Syphilis
Gummas, cardiovascular syphilis (CNS involvement (for neurosyphilis treatment, see below)
- Diagnosis
- Appearance of soft skin lesions and ulcers
- CXR shows linear calcifications of aorta
- Perform LP to rule out neurosyphilis
- Treatment
- Benzathine penicillin G 7.2 million units administered as 3 weekly doses of 2.4 million units
Neurosyphilis
Note: Can occur at any stage | Includes cranial nerve dysfunction, meningitis, stroke, altered mental status, auditory/ophthalmic abnormalities | Tabes dorsalis and paresis are late manifestations and can occur 10 to 30 years after infection
- Diagnosis
- Lumbar puncture: Test CSF for white blood cell count, protein and VDRL
- Treatment
- Aqueous crystalline penicillin G, 3 to 4 million units IV every 4 hours for 10 to 14 days or penicillin G procaine, 2.4 million units IM daily plus probenicid 500 mg orally 4 times daily, for 10 to 14 days
Note: The durations of the recommended and alternative regimens for neurosyphilis are shorter than the duration of the regimen used for latent syphilis | Therefore, benzathine penicillin, 2.4 million units IM once per week for 1 to 3 weeks, can be considered after completion of these neurosyphilis treatment regimens to provide a comparable total duration of therapy
KEY CLINICAL POINTS:
- Penicillin Allergy
- Patients with penicillin allergy should be desensitized and treated with penicillin whenever possible
- Doxycycline 100 mg BID x 14 days or tetracycline 500 mg 4 times daily for 14 days can be used for nonpregnant penicillin-allergic patients with primary or secondary syphilis
- Counsel patients regarding Jarisch-Herxheimer reaction
- Acute febrile reaction frequently accompanied by headache, myalgia, and fever
- Occurs within initial 24 hours after initiation of any syphilis therapy
- Reaction to treatment and not an allergic reaction to penicillin
- Occurs most frequently among persons who have early syphilis (likely due to heavier bacterial loads at this stage)
- Manage with antipyretics
- Nontreponemal titers decline after treatment and eventually become negative
- Treponemal tests remain positive for life
- Follow-up at
- 6, 12, 18 and 24 months after therapy and should include serology
- If symptoms persist or recur, or there is a >4 fold increase in nontreponemal test titer persisting more than 2 weeks
- consider reinfection or treatment failure
- retreat and check HIV status
- Sexual transmission occurs only when mucocutaneous lesions are present and is uncommon after the first year
- Persons exposed sexually to those with primary, secondary or early latent syphilis should be evaluated clinically and serologically
Learn More – Primary Sources:
USPSTF: Screening for Syphilis Infection in Pregnant Women
USPSTF: Screening for Syphilis Infection in Nonpregnant Adolescents and Adults
CDC Sexually Transmitted Diseases: Syphilis
CDC: Syphilis Treatment Guidelines
Review Article: Syphilis Infection during Pregnancy: Fetal Risks and Clinical Management
BMJ Clinical Updates: Syphilis
Conception Strategies and Care for Persons of Childbearing Age with HIV
SUMMARY:
There are strategies for couples who want to conceive when one or both partners have HIV. Thanks to highly active antiretroviral therapy (HAART), men and women are living longer, with better quality of life and may wish to have their own biologic children. The safest option remains sperm insemination from an HIV-negative donor. However, if donor sperm is not an acceptable option, the CDC presents the following risk reducing approaches for consideration:
- Expert consultation recommended to tailor guidance
- Partner with HIV: Should achieve sustained viral suppression (e.g. two recorded measurements of undetectable viral loads ≥ 3 months apart)
- If partner with HIV has sustained viral suppression very low risk of transmission of HIV to partner
- Option for daily oral antiretroviral preexposure prophylaxis (PrEP) while attempting conception, starting 20 days prior to exposure and for 28 days after last vaginal exposure
- Consider PrEP if HIV partner has not achieved sustained viral suppression, or if concerned about inconsistent HAART adherence
- Both partners should be screened for STIs
- Time condomless sex to coincide with ovulation
- Referral to fertility specialist if no conception by 6 months
Strategy 1: Intercourse without condom limited to ovulation
- Men on HAART with undetectable plasma viral loads might still be at low risk (1.2 per 100 person-years, CI = 0.9–1.7) for transmitting HIV-1 to their female partner through condomless sexual intercourse
Or
Strategy 2: Collection and washing of the male partner’s sperm to remove cells infected with HIV with follow up testing to ensure absence of HIV prior to IUI or IVF
- 1.3%–7.7% of washed specimens may test positive after washing and should be discarded
- Unknown whether there is greater benefit with IVF vs. IUI
- In theory, because IVF is more efficacious compared to IUI, there may be reduced exposure to infected sperm
- Unknown if any difference with ICSI
The authors of the CDC Morbidity and Mortality Weekly Report (MMWR) refer to ACOG and ASRM guidance:
The American College of Obstetricians and Gynecologists, the American Society of Reproductive Medicine, and others have published guidance documents that emphasize the importance of considering HIV a chronic disease or disability, which should not result in discrimination and for which fertility treatment should be offered if it is desired.
Learn More – Primary Sources:
Locate a Reproductive Endocrinologist:
CDC Guidelines on Antiretroviral Preexposure Prophylaxis to Prevent HIV in Those at Risk
SUMMARY:
The CDC has published updated guidelines on the use of PrEP – a pharmacologic approach to reduce HIV risk. Guidelines now simplify counseling recommendations to include all sexually active adolescents and adults, and higher risk groups should be routinely prescribed PrEP. PrEP medication options are also expanding with two approved daily oral antiretroviral preexposure prophylaxis (PrEP) medications and an intramuscular antiretroviral medication pending FDA approval.
CDC Guidance
General Counseling and Offering of PrEP
- All sexually active adults
- Should be counseled on risks of STI, including HIV
- Should be informed about PrEP to improve general awareness
- PrEP can be prescribed after options-counseling to
- All HIV negative individuals who are interested and request PrEP and
- Weigh at least 35kg (77 lb)
Higher Risk Populations
- PrEP should be routinely prescribed for all persons who are HIV negative and are at on-going higher risk for transmission of HIV, defined as
- Sexually active patients (anal or vaginal sex in the past six months) AND one of the following risk factors
- HIV-positive sexual partner (especially if partner has unknown or detectable viral load) or
- 1 or more sexual partners with unknown HIV status without consistent use of condoms or
- Diagnosed with bacterial STI in the past 6 months | MSM diagnosed with gonorrhea, chlamydia, or syphilis | MSW and WSM diagnosed with GC or syphilis
- Persons without HIV who have injected drugs in the past 6 months and
- HIV+ injecting partner or
- Sharing injection equipment
- Persons who have been prescribed PEP (post-exposure prophylaxis) and
- report continued risk behavior or
- have used multiple courses of PEP
- Sexually active patients (anal or vaginal sex in the past six months) AND one of the following risk factors
USPSTF Guidance (June 2019)
The USPSTF recommendations do not yet reflect updated CDC guidance and currently recommends only offering PrEP to persons at high risk of HIV acquisition. This recommendation is Grade A, which means that PrEP should be offered or provided in the appropriate clinical settings (see below). In addition, the USPSTF document states that while PrEP is associated with “small harms” (e.g., kidney and GI events), overall
The USPSTF found convincing evidence that PrEP is of substantial benefit for decreasing the risk of HIV infection in persons at high risk of HIV infection, either via sexual acquisition or through injection drug use. The USPSTF also found convincing evidence that adherence to PrEP is highly correlated with its efficacy in preventing the acquisition of HIV infection.
What is PrEP
PrEP is an anti-retroviral medication (or medications) to prevent the transmission of HIV and not recommended for the treatment of HIV
Oral Formulations
- Oral pill taken daily
- Emtricitabine (F) 200 mg and tenofovir disoproxil fumarate (TDF) 300 mg (F/TDF, Truvada) to prevent HIV infection among all persons at risk through sex or injection drug use
- Emtricitabine (F) 200 mg tenofovir alafenamide (TAF) 25 mg tablet (F/TAF, Descovy) taken daily to prevent HIV infection among persons at risk through sex, excluding people at risk through receptive vaginal sex because due to lack of studies for this indication
- Effectiveness estimates
- Sexual transmission route: approximately 99% effective
- Injection drug use: 74 to 84% effective (based on tenofovir alone and may be higher with combination pill)
- Effectiveness strongly related to adherence to PrEP
Intramuscular Formulation
- Cabotegravir (600mg) is an IM injection in the gluteal muscle recommended (conditional on FDA approval) every 2 months
- In persons concerned about side effects, can consider a 30mg daily oral cabotegravir for a 4-week lead-in prior to injections
Clinical Actions
- Clinical eligibility
- HIV testing confirming negative status before starting PrEP
- No signs/symptoms of acute HIV infection
- No contraindication or allergies to medications
- Recommended laboratory testing based on oral PrEP regimen versus IM PrEP regimen
- Document pregnancy intention
- Screen/treat STIs
- Recommend regular monitoring of HIV infection status, side effects, adherence, and sexual or injection risk behaviors as well as STI testing, pregnancy testing, and additional laboratory results
- Reinforce the importance of adherence and HIV risk reduction, including encouraging condom use for additional protection
- While on oral PrEP, requires assessment of renal function at 3 months and every 6 months after, using Cockcroft-Gault formula
- F/TDF: Approved for use in persons with eCrCl >60 ml/min
- F/TAF: Approved for use in persons with eCrCl ≥30 ml/min
- While on IM PrEP, does not require assessment of renal or liver function
- STI screening should be administered every 6 months even if asymptomatic
- Stop PrEP if
- Patient requests to stop | Counsel regarding other preventative measures
- Patient now HIV positive | Manage or refer for treatment
Dosage
Initiation of oral PrEP
- Daily oral pill of F/TDF or F/TAF prescription
- Limit prescription to a 90 day corresponding to every 3 month HIV testing
- Prior to prescription, laboratory assessment requirements includes renal infection, hepatitis B virus infection, and lipid profile (F/TAF)
- Side effects in clinical trials were mild | early side effects include mild GI distress that resolved the first month or headache
- Serious side effects are rare however can impair renal function | Serum creatinine monitoring required
- Liver function can be adversely affected and patients should report symptoms (e.g. tea colored urine, light colored stool etc.)
Intramuscular Regimen
- Administration of cabotegravir 600mg via one 3mL intramuscular injection in the gluteal muscle | Initiation of cabotegravir requires a second dose 4 weeks after the first dose (one month follow up visit) and every 8 weeks after with HIV testing at visits
- Can consider trial of cabotegravir 30mg daily for four weeks prior to initiation of IM injections if patients are anxious about side effects
- Schedule is initial administration (month 0), one month after initiation (month 1), then every 8 weeks afterwards (month 3, 5, 7, etc.)
- Follow-up visit one month after initial injection should include second dose and HIV Ag/Ab test and HIV-1 RNA assay with subsequent 2-month intervals
- The following laboratory tests are NOT indicated before starting CAB injection or for monitoring patients during its use
- Creatinine or eCrCl
- hepatitis B serology
- lipid panels
- liver function tests
- Minimal side effects were noted
PrEP Maintenance
- Patients on PrEP should return to their health care provider every 3 months with oral PrEP and every 2 months for intramuscular PrEP and should include:
- HIV testing to ensure sero-negative
- Prescription refill
- Assess and counseling regarding medication adherence and risk reduction behaviors
- Laboratory testing including STIs and pregnancy
- Address any concerns, including side effects
- Renal Assessment required for oral daily dosing of PrEP but not IM dosing of PrEP
- Patients <50 or with with eCrCl >90 at initiation should have renal function assessed every 12 months
- Impaired renal function should trigger evaluation every 6 months
- Thresholds | F/TDF: Approved for use in persons with a eCrCl >60 ml/min, F/TAF: Approved for use in persons with eCrCl ≥30 ml/min
- A rise in creatinine is not a reason to withhold treatment, as long as above the threshold as above
NOTE: Renal function monitoring not required with cabotegravir
- Lipid panel is recommended annually in patients taking F/TAF
- Hepatitis B serology testing is only recommended at initiation of PrEP
- Hepatitis C testing is recommended annually for MSM, TGW, and PWID
HIV-discordant Couples and Pregnancy
- Conception and pregnancy
- PrEP is one of several options to protect the partner who is HIV-negative (see related ‘ObG Topics, below) in a couple considering pregnancy
- Data on use of the PrEP medication has not shown increased risk of birth defects nor risk to breastfeeding children
Breastfeeding
- The CDC states that “F/TDF as PrEP is considered generally safe for pregnant and breastfeeding women”
- For F/TDF, the FDA label states
The health benefits of breastfeeding and the mother’s clinical need for PrEP should be considered along with any potential adverse effects on the breastfed child from TRUVADA balanced against the risks of HIV-1 acquisition due to nonadherence and subsequent mother to child transmission. Women should not breastfeed if acute HIV-1 infection is suspected because of the risk of HIV-1 transmission to the infant
PrEP vs PEP
- PrEP is only for people who are at ongoing substantial risk of HIV infection
- For a single high-risk event of potential HIV exposure (e.g., unprotected sex, needle-sharing injection drug use, or sexual assault—use postexposure prophylaxis (PEP) option, or PEP within 72 hours of exposure (see ‘Learn More – Primary Sources’ below)
KEY POINTS:
All sexually active adolescents and adults who are sexually active should be counseled on and offered PrEP regardless of risk designation
PrEP should be routinely prescribed for patients at higher risk of HIV acquisition, including:
- Sexually active patients (anal or vaginal sex in the past six months) AND one of the following risk factors
- HIV-positive sexual partner (especially if partner has unknown or detectable viral load) or
- 1 or more sexual partners with unknown HIV status without consistent use of condoms or
- Diagnosed with bacterial STI in the past 6 months | MSM diagnosed with gonorrhea, chlamydia, or syphilis | MSW and WSM diagnosed with GC or syphilis
- Persons without HIV who have injected drugs in the past 6 months and
- Have HIV+ injection partners or
- Share injection equipment
- Persons who have been prescribed PEP (post-exposure prophylaxis) and
- report continued risk behavior or
- have used multiple courses of PEP
Learn More – Primary Sources:
CDC: Pre-Exposure Prophylaxis (PrEP)
NIH: Pre-Exposure Prophylaxis (PrEP)
ACOG: Preexposure Prophylaxis for the Prevention of Human Immunodeficiency Virus
Prostate Cancer Screening: The Basics
SUMMARY:
Prostate cancer is one of the most common types of cancer that affects patients. In the United States, lifetime risk of prostate cancer is approximately 11%, and the lifetime risk of dying of prostate cancer is 2.5%. Many patients will die with prostate cancer but not necessarily of prostate cancer. In autopsy studies, 20% of patients aged 50 to 59 years old and more than 33% of patients aged 70 to 79 years old were found to have prostate cancer. The overall median age of death from prostate cancer is 80, with more than two-thirds of all patients who die of prostate cancer being older than 75 years old. Measuring the amount of prostate specific antigen (PSA) can be a helpful tool in diagnosing prostate cancer. While population-wide screening is not currently recommended, there is a role for shared decision making for certain groups.
Goals, Benefits and Harms of Prostate Screening
Goal of Prostate Cancer Screening
- To prevent morbidity and mortality associated with advanced or metastatic disease by identifying high-risk, localized prostate cancer and reducing prostate cancer mortality
- Positive PSA screening test can by followed by a diagnostic transrectal, ultrasound guided, core-needle prostate biopsy that can guide treatment recommendations
Benefits of Early Detection and Treatment
- RCTs demonstrate that PSA-based prostate cancer screening in patients with a prostate aged 55 to 69 years may prevent approximately 1.3 deaths from prostate cancer over 13 years per 1000 individuals screened
- Screening may also prevent approximately 3 cases of metastatic disease
- There has been a 75% reduction in presentation with metastatic disease since PSA screening for prostate cancer
- However, current data shows no reduction in all-cause mortality with screening
Harms Associated with Screening
- Psychological Harm: Overdiagnosis
- Some patients are being treated for a cancer that would otherwise never have become symptomatic during the patient’s lifetime
- Exact rate of overdiagnosis is unknown but estimated to be as high as 50%
- Complications of prostate biopsy resulting from a positive screen result
- Procedure is painful | Hematospermia | Prostatitis
- Risk of infection: 4% risk of infection-related hospitalization
Who to Screen? AAFP and USPSTF Recommendations
- Screening
- Addresses early, pre-symptomatic screening for asymptomatic prostate cancer
- Is not intended for individuals with symptoms that could be related to either locally advanced or metastatic prostate cancer
- Is based on PSA levels
- Data is insufficient to recommend the following
- Digital rectal exam (DRE): DRE does not improve detection of prostate cancer and should not be performed as part of screening
- PSA derivatives and isoforms: e.g., free PSA, -2proPSA, prostate health index, hK2, PSA velocity or PSA doubling time
- Novel urinary markers and biomarkers: e.g., PCA3
Individuals Aged 55 Through 69
- Population-wide PSA based screening for prostate cancer is not recommended
- 55 through 69 years: Use shared decision making
- Benefits: PSA screening may reduce mortality from prostate cancer in a small number of individuals
- Harms: The cost of screening may place many individuals at risk for long term harms as described above | Current trials have demonstrated no reduction in all-cause mortality from prostate cancer screening at the population level
- If the individual desires to undergo screening with PSA testing, do not be screen more frequently than every 2 years
- A common PSA threshold level of 4.0 ng/mL is used to direct further workup and intervention, however thresholds vary by lab and professional society
For Individuals Aged 70 and Older
- Recommendation against screening
- Individuals in this age group are more likely to die from a cause other than their prostate cancer
- Patients typically experience more harms than benefits from screening: False positives | Overdiagnosis | Increased risk from biopsy and treatment
High Risk Populations
- There is insufficient evidence to determine whether individuals at increased risk for prostate cancer are more likely to benefit from screening
- Individuals with increased risk of prostate cancer include
- African American
- Family history of prostate cancer
- African American individuals with a first degree relative have 3 times the average risk
- White individuals with a first degree relative have double the average risk
KEY POINTS:
- General, population-wide screening for prostate cancer using PSA is not recommended
- Starting at age 55 through 69, a discussion with the patient can allow for an informed, shared decision to proceed with screening if desired
- Screening should consist of a PSA test, with a testing interval of no more than 2 years
- In general, If PSA levels are >4.0ng/mL, further workup including imaging, biopsy, and referral to urologist should be considered
- Screening for prostate cancer with PSA in individuals aged ≥70 years is not recommended
- No recommendation exists for high-risk populations
- The decision on screening should be individualized between the clinician and patient
Learn More – Primary Sources:
AUA: Early detection of prostate cancer
USPSTF: Screening for Prostate Cancer – US Preventive Services Task Force Recommendation Statement
ACS: Prostate Cancer Screening
Nonalcoholic Fatty Liver Disease (NAFLD) – Diagnosis and Management
SUMMARY:
37% of American adults have NAFLD and as many as 70% with T2DM have NAFLD. While usually asymptomatic, NAFLD significantly increases the risk of cardiovascular disease, diabetes and liver disease including cirrhosis and liver cancer. Findings of fatty liver on imaging and/or elevated liver function tests require evaluation for NAFLD. Obese patients, especially those with metabolic issues (hypertension, (pre) diabetes, cardiovascular disease) should all be evaluated for NAFLD. Evaluation of NAFLD starts with non-invasive blood test monitoring and measuring liver stiffness. Treatments of NAFLD is multidisciplinary, including weight loss, alcohol evaluation, medications, evaluation and control of metabolic issues, and often referral to hepatologists, cardiologists, endocrinologists, dieticians, and sometimes bariatric surgeons.
Definitions
- Nonalcoholic Fatty Liver Disease (NAFLD): General term for anyone with fatty liver
- Nonalcoholic Steatohepatitis (NASH): Aggressive form of NAFLD, usually fatty liver and elevated liver enzymes
- Liver biopsy may be needed to confirm this diagnosis
- Diagnosis implies minimal alcohol
- <14 drinks week for women
- <21 drinks per week in men
- Often NASH may be combined with alcoholic liver disease
- Liver fibrosis (i.e., liver scarring)
- Fibrosis correlates with increased risk of cirrhosis
- Mild to moderate fibrosis may be reversible
- Four stages, from minimal F1 to cirrhosis F4
- Cirrhosis
- Liver is scarred
- Scarring is rarely reversible
- Decompensated cirrhosis
- cirrhosis with any of the following
- Hepatic encephalopathy
- Ascites
- Variceal bleeding
- Hepatocellular carcinoma
- Hepatorenal syndrome
- Failing liver may require transplant
- cirrhosis with any of the following
Clinical Presentation
- Fatty liver found incidentally on liver imaging done for nonliver causes
- Abnormal LFT’s found on routine lab testing
- Low platelet count may be first sign of cirrhosis
- Usually asymptomatic unless evidence of decompensated cirrhosis
- Physical exam regarding liver is usually normal unless decompensated cirrhosis
Risk Factors
- Type 2 diabetes or prediabetes requires screening for NAFLD
- Patients with at least 2 manifestations of metabolic syndrome
- Hypertension
- dyslipidemia especially high triglycerides and low HDL
- central obesity
- 2 or more factors require screening for NAFLD
Evaluation
History and Physical
- Examine for signs of cirrhosis
- Jaundice
- Spider angiomata
- Gynecomastia
- Hepatosplenomegaly
- Caput medusae; dilated abdominal vein
- Testicular atrophy
- Clubbing
- Dupuytren’s contracture
- Asterixis with hepatic encephalopathy
Labs
- Routine Labs
- CBC, complete metabolic profile, lipid profile, TSH, INR, HbA1C
- Cardiovascular disease screening such as stress echo or cardiac ct
- Diabetes screening – HgB A1C
- Screen for other liver diseases
- HCV antibody | HCV RNA
- HbsAg, HBsAb, HBcAb
- Autoimmune panel: Antinuclear antibody, Antimitochondrial antibodies (AMA), immunoglobulin IGG
- Ferritin | Alpha 1 antitrypsin
- CRP, CRP, Anti smooth muscle Ab, Anti mitochondrial antibodies
- FIB-4: Estimate amount of liver scarring fibrosis
- Most popular noninvasive blood test for liver fibrosis
- Requires age, AST, ALT, platelet count
Scoring
- <1.3: Low risk for liver fibrosis
- 1.3 to 2.67: Indeterminant risk for liver fibrosis
- >2.67: High risk for advanced cirrhosis/cirrhosis
Reference
Imaging
- Routine: Liver ultrasound
- Liver stiffness measurement (LSM) via transient elastography (FibroScan)
- Best screening imaging test for fibrosis | Based on FIB-4 Score
- Fib-4 <1.3: Not needed
- FIB-4 of 1.3 to 2.67: Needed
- Fib-4 >2.67: Consider FibroScan
- LSM risk assessment
- <8 kPa: Low risk for liver fibrosis
- 8 to 12 kPa: Indeterminate risk for significant liver fibrosis
- >12 kPa: High risk for advanced fibrosis/cirrhosis
- Best screening imaging test for fibrosis | Based on FIB-4 Score
Additional Studies
- Typically ordered by hepatologist
- Liver biopsy
- Magnetic Resonance Elastography (MRE) may be needed
Screen for Alcohol Use and Abuse
- The Alcohol Use Disorders Identification Test (AUDIT) 10-item screening tool developed by WHO (see ‘Learn More – Primary Sources’ below)
or
- CAGE Screening Tool
Treatment
Lifestyle Guidance
- Exercise
- Mediterranean diet
- Avoid all alcohol if indeterminant to high-risk fibrosis
- If overweight
- Advise structured weight loss plan
- Consider anti-obesity medication
- Consider bariatric surgery
Medications
- There are no FDA approved medications for NAFLD | Consider medication for indeterminant or significant fibrosis
- NASH w/o T2D and no cirrhosis: Vitamin E 800 IU daily
- Diabetics and NASH: Consider Semaglutide
- Once a week 0.25 mg weekly subQ for 1 month, then increase to 0.5 mg subQ once a week (Ozempic)
- 3 mg po once a day for 1 month, then increase to 7 mg po once a day (Rybelsus)
- NASH with or without diabetes consider Pioglitazone (Actos) 15 to 30 mg po once daily
- Obesity and NASH: Consider Liraglutide (Saxenda) or Semaglutide (Wegovy), both FDA approved for weight loss (not FDA approved for liver disease)
- Liraglutide (Saxenda) is given subQ daily, Semaglutide (Wegovy) is given Subq weekly, both require starting at low dose and increasing slowly to therapeutic dose | Both very expensive with potential side effects especially nausea, vomiting, diarrhea
- Do NOT combine liraglutide with semaglutide
KEY POINTS:
- Liver fibrosis is the most important determination of the significance of NAFLD
- NAFLD significantly increases risk of cardiovascular disease
- 11% of patients with fatty liver are at risk for advanced liver fibrosis
- Elevated LFTs + fatty liver = higher risk of liver fibrosis
- Statins
- If indicated, should be given
- No contraindication if LFTs are abnormal from NAFLD
- Soluble statins (simvastatin, atorvastatin) reduce risk of liver decompensation
- Contraindicated in decompensated cirrhosis
- Specialist Referrals
- Hepatologist if indeterminant or advanced fibrosis
- Endocrinologist may be indicated for (pre)diabetes control
- Cardiologist for screening for cardiovascular disease
- Bariatric surgery consultation if indicated
- Liver cancer screening every 6 months if advanced fibrosis/cirrhosis
Quick Links
CAGE Screening Tool Calculator
LEARN MORE – Primary sources
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
