American Gastroenterology Association (AGA) Clinical Practice Obesity Guideline Including Pharmacological Interventions

Summary: 

Obesity, defined by the CDC as a weight that is higher than what is considered healthy for a given height, has been increasing in prevalence over several decades. Roughly two thirds of adults are considered obese or overweight, with a recent estimate putting the prevalence of adults with obesity at nearly 42% of the population. It is customary to use BMI calculations as both a screening tool and to further characterize the degree of obesity, but it is important to note that BMI does not diagnose a patient’s health or even degree of body fat. Healthcare providers should combine appropriate clinical assessments, considering body weight, central fat distribution, functional status, and presence of obesity related complications, to create a more accurate picture of a patient’s health. In recent years we have gained a better understanding of what contributes to obesity and what helps a patient maintain a healthy weight. The AGA has accordingly updated their guidelines on pharmacological interventions for adults with obesity to better help clinicians care for their obese patients.  

Diagnosis 

All adults should be screened for obesity by obtaining a height and weight and calculating BMI during a routine physical exam 

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BMI can be calculated via calculator or by dividing weight (kg) over height (m)² 

• Underweight: <18.5 kg/m ² 
• Normal weight: ≥18.5 to 24.9 kg/m ² 
• Overweight: ≥25.0 to 29.9 kg/m ² 
• Obesity: ≥30 kg/m ² 

Obesity can be further characterized by class 

• Class I: 30.0 to 34.9 kg/m ² 
• Class II: 35.0 to 39.9 kg/m ²  
• Class III: ≥40 kg/m ² 

A BMI over 25 kg/m ² should prompt further evaluation including 

• Measurement of waist circumference: > 40 inches in men and > 35 inches in women is associated with increased risk for obesity related complications 
• Screening for obesity related complications (see below) 
• Consideration of causes of weight gain not related to diet and activity level (e.g., hypothyroidism, drug side effect, depression, Cushing’s syndrome)  
• Blood pressure measurement  
• Fasting glucose and lipid levels 

Note: A BMI > 23 kg/m² may indicate the need for further evaluation in patients of South Asian, Southeast Asian, and East Asian descent as obesity related complications develop at lower BMIs in these populations 

 Obesity related complications 

• Type 2 Diabetes Mellitus (T2DM), Prediabetes  
• Cardiovascular disease 
• Hypertension 
• Hyperlipidemia 
• Obstructive sleep apnea 
• Obesity hypoventilation syndrome 
• Nonalcoholic fatty liver disease 
• Osteoarthritis 
• Stroke 
• Certain malignancies (e.g., colorectal cancer, endometrial cancer) 
• Depression  
• PCOS, Infertility  
• GERD  
• Urinary incontinence 
• VTE 
• Gallstones  

Lifestyle Interventions 

The cornerstones of weight loss management are individualized dietary changes and increased physical activity. Recent guidelines, including the USPSTF recommendations, recommend the use of behavioral therapy and a multidisciplinary approach involving weight loss counselors, psychologists, physical therapists and dieticians to assist the patient in establishing and reaching their weight loss goals.  

Weight loss goals should be modest 

• A weight reduction of 5% to 10% of initial body weight is sufficient to yield significant health benefits including decreased risk of diabetes and cardiovascular disease  
• A 5% weight loss within 3 months is used by the US Food and Drug Administration (FDA) to assess the efficacy of medications to treat obesity 

Increased calorie expenditure 

• Adults should perform at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic activity per week (or an equivalent combination of these)  

Decreased calorie intake 

• Reducing daily calorie intake to 1200 to 1500 for women and 1500 to 1800 for men  
• Estimating an individual’s daily energy requirements and aiming for an energy deficit of 500 kcal/d or 750 kcal/d  

Pharmacological Therapies 

In adults with obesity or overweight with weight-related complications, who have had an inadequate response to lifestyle interventions, the AGA recommends adding pharmacological agents to lifestyle interventions over continuing lifestyle interventions alone.

Clinical Considerations 

Anti-obesity medications (AOMs) are not recommended for: 

• Pregnant women  
• Patients with bulimia nervosa  

Use caution when starting AOMs for patients with: 

• Diabetes treated with insulin or insulin secretagogues (e.g., sulfonylureas) as AOMs may decrease blood sugar levels 
• Hypertension or those on blood pressure lowering agents, as AOMs may lower blood pressure as weight is lost  
• Binge eating disorder  

Cost of AOMs may limit their access and data on cost-effectiveness is limited 

Recommended Anti-Obesity Medications 

Semaglutide (Wegovy)     

• Largest magnitude of net benefit, so can be considered first line prior to other drugs 
• Dosing is started at 0.25 mg/week escalated gradually to goal of 2.4 mg/week 
• Delays gastric emptying, may cause nausea and emesis which is mitigated by slow taper to goal dose 
• Can maintain on highest dose tolerated  
• Contraindications: History of pancreatitis|Hx or FHx of Medullary Thyroid Cancer| Hx of FHx of MEN-2A or MEN-2B 
• Associated with increased risk of pancreatitis and biliary disease  
• Used in Diabetes under brand name Ozempic 

Liraglutide (Saxenda)   

• Escalate dose gradually to a target dose of 3mg daily  
• Can maintain at highest dose tolerated 
• Associated with nausea, emesis due to delayed gastric emptying 
• Associated with increased risk of pancreatitis and biliary disease 
• Contraindications: History of pancreatitis or FHx of Medullary Thyroid Cancer| Hx of FHx of MEN-2A or MEN-2B 
• Used in DM under brand name Victoza 

Tirzepatide (Mounjaro) 

• Not included in AGA guidelines, but promising results from recent trial published in NEJM (see “Primary Sources – Learn More” below)

Phentermine-Topiramate ER (Qsymia) 

• Useful in patients who also have migraines given the Topamax component  
• Avoid in patients with cardiovascular disease and hypertension 
• Monitor HR and BP regularly while on this medicine 
• Topamax is teratogenic and women of child-bearing age should be appropriately counseled  
• Pregnancy test should be obtained prior to initiation 
• Multiple drug interactions exist 

Naltrexone-Bupropion ER (Contrave) 

• Useful in patients with concomitant depression or desire to quit smoking  
• Avoid in patients with seizure disorders and those on opiates 
• Monitor HR and BP regularly while on this medicine 

Orlistat (Xenical) 

• No longer recommended due to minimal effects and significant GI adverse effects  

Phentermine (Adipex) 

• Approved by the FDA for short term use (12 weeks) but used off label for chronic weight loss management 
• Typically not recommended as first line therapy due to side effects and potential for abuse 
• Avoid in patients with cardiovascular disease 
• Avoid in patients with history of drug abuse 
• Monitor HR and BP regularly while on this medicine 

Diethylpropion (Amfepramone) 

• Approved by the FDA for short term use (12 weeks) but used off label for chronic weight loss management  
• Typically not recommended as first line therapy due to side effects and potential for abuse 
• Avoid in patients with cardiovascular disease 
• Monitor HR and BP regularly while on this medicine 

Future therapies 

Gelesis100 Oral Superabsorbent hydrogel 

• Space occupying gel to decrease appetite and PO intake 
• Delivered in the form of a pill with 3 pills take with water prior to lunch and dinner 
• For patients with BMI of 25 to 40 kg/m ² 
• Currently in use via clinical trials  

Surgical Management 

While not addressed in the recent AGA guidelines, the AGA did publish guidelines in 2017 that included surgical management options

Bariatric Endoscopy 

• Intragastric balloon 
• Aspiration therapy  
• Endoscopic sleeve gastroplasty 
• Transoral outlet reduction 

Bariatric Surgery 

• Laparoscopic sleeve gastrectomy  
• Laparoscopic Roux-en-Y gastric bypass  
• Adjustable gastric banding 

Primary Sources – Learn More: 

AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity

Behavioral Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults US Preventive Services Task Force Recommendation Statement

White Paper AGA: POWER — Practice Guide on Obesity and Weight Management, Education, and Resources

Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline

AJMC: A Review of Current Guidelines for the Treatment of Obesity

CDC: Overweight and Obesity

NEJM: Tirzepatide Once Weekly for the Treatment of Obesity

CDC: Adult BMI Calculator | Healthy Weight, Nutrition, and Physical Activity

Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline from the American College of Physicians 

SUMMARY: 

Low back pain is a common complaint in outpatient settings, with an estimated 25% of adults reporting an episode of low back pain lasting for at least one day in the past three months. It is associated with high healthcare costs and is a leading cause of activity limitation and missed worked days globally. The diagnosis of low back pain can be clinically frustrating, with the majority of cases unattributable to a specific cause. The American College of Physicians last released guidelines to aid in diagnosis and treatment of low back pain in 2007, and updated their treatment guidelines in 2017, stressing non-pharmacological therapies for most types of back pain.  

Clinical Presentation  

Diagnosis  

• Obtain detailed history and physical  
  • Pay attention for signs and symptoms of radiculopathy or spinal stenosis 
  • Assess for other symptoms or illnesses that may contribute to back pain (e.g., history of autoimmune disease, falls, and injuries) 
• Imaging is typically not recommended for non-specific back pain, and should only be done when it will change management 

Etiologies  

• Mechanical: Lumbar Strain | Fracture | Osteoporosis | Herniated Disc | Degenerative disc disease  
• Non-Mechanical: Malignancy | Osteomyelitis | Abscess | Inflammatory arthritis  
• Visceral: Prostatitis | Endometriosis | Pancreatitis | Nephrolithiasis | Aortic aneurysm 
• The vast majority of back pain will be non-specific with no obvious etiology 

Definitions  

• Acute: Pain lasting less than 4 weeks  
• Subacute: Pain lasting 4 to 12 weeks 
• Chronic: Pain lasting over 12 weeks 

Treatment for Acute/Sub-Acute Low Back Pain  

Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants.

Pharmacologic therapy 

• No benefit: Tylenol | Systemic steroids 
• Small benefit 
  • NSAIDs: Improved pain and function | Should be used at lowest effective dose for short periods of time to reduce associated risks (e.g., renal, GI risks)  
  • Skeletal muscle relaxants (SMR): Provided short term pain relief with studies showing no difference in outcomes between different SMRs 
• Insufficient evidence to determine benefit: Antidepressants | Opioids | Benzodiazepines | Antiepileptics 

Non-Pharmacologic  

• No benefit: Exercise | Lumbar supports 

Benefit 

• Improved pain and function: Massage | Heat wrap | Low-level laser therapy (in conjunction with NSAIDs)  
• Acupuncture improved pain only 
• Spinal manipulation improved function only  

Insufficient evidence 

• Transcutaneous electrical nerve stimulation (TENS) | Electrical muscle stimulation | Inferential therapy | Short-wave diathermy | Traction | Superficial cold (ice) | Motor control exercise (MCE) | Pilates | Tai chi | Yoga | Psychological therapies | Multidisciplinary rehabilitation | Ultrasound | Taping  

Note: Clinicians should reassure patients that the vast majority of acute/subacute low back pain improves with time regardless of therapies used 

Treatment for Chronic Low Back Pain  

For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation.

Non-Pharmacologic Therapy  

Should be used first line due to minimal associated risks compared to pharmacologic therapies  

No benefit: Foot reflexology | Ultrasound | Transcutaneous electrical nerve stimulation (TENS) | Taping  

Benefit 

• Improved pain and function: Exercise | Motor control exercise (MCE) | Tai chi | Yoga | Psychologic therapies (e.g., progressive relaxation therapy) | Multidisciplinary rehabilitation | Acupuncture | Massage | Low-level laser therapy 
• Improved pain only: Electromyography biofeedback | Operant therapy | Cognitive behavioral therapy | Spinal manipulation 

Insufficient evidence 

• Lumbar support | Electrical muscle stimulation | Interferential therapy | Short-wave diathermy | Traction | Superficial heat or cold 

In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. 

Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits out-weigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. 

Pharmacologic Therapy  

No benefit:  

• TCAs | SSRIs 

Benefit:  

• NSAIDs: Improved pain with possible small improvement in function. No difference in outcomes between NSAID types. Should be given at lowest effective dose for short periods of time to reduce harm 
• Opioids: Improved short-term pain and function. No clear difference between opioid types and formulations (e.g., long vs short acting). Tramadol also effective 
• Benzodiazepines: Specifically, tetrazepam improved pain  
• SNRIs: Duloxetine improved pain and function  

Insufficient evidence: SMRs | Tylenol | Systemic steroids | Antiepileptics  

Key Points:  

• Patient should be encouraged to remain active as tolerated despite low back pain 
• Improvements in pain and function with different therapies (pharmacologic and non-pharmacologic) were small and many studies reviewed had low-quality evidence  
• Few differences exist between the different pharmacologic and non-pharmacologic therapies outlined above 
• Providers should use shared decision-making with the patient to choose which therapy would be most likely to help, based on individual patient traits and discussion of risks and benefits 

Primary Sources – Learn More: 

Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians

Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society

Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017

AAD Guidelines for Management of Acne Vulgaris 

Summary: 

Acne vulgaris (AV) is a multifactorial chronic inflammatory skin disease that affects an estimated 50 million people in the United States, including approximately 85% of teenagers. While AV is not life threatening in and of itself, it is associated with significant physical and psychological morbidity and healthcare costs. The American Academy of Dermatology (AAD) has released guidelines for managing acne in adolescents and adults.  

Quick Navigation

Classification and Grading: 

• Currently no universal classification or grading system in recommended 
• Despite this, acne is typically divided into mild, moderate and severe categories to help guide treatment and monitor for improvement with therapies 

Mild Acne 

• Typically limited to scattered comedones without scarring or nodules  
• First line treatment includes: Benzoyl peroxide (BP) | Topical retinoid | Topical combination (BP +/- Retinoid +/- antibiotic) 

Moderate Acne 

• Visually obvious nodules, papules and comedones  
• First line treatment includes: Topical combination therapy | Oral antibiotic + BP + retinoid | Oral antibiotic + topical antibiotic + BP + retinoid  

Severe Acne  

• Extensive and prominent nodules, papules and comedones with associated scarring  
• First line treatment includes: Oral antibiotic + topical therapy | Oral isotretinoin  

Further Testing: 

Microbiologic testing 

• Not recommend in the absence of suspicion for gram negative folliculitis  
• Gram negative folliculitis is a rare condition with uniform and eruptive pustules in the perioral and perinasal regions, typically in the setting of prolonged tetracycline use 
• Endocrinologic testing 
• Not recommended in the absence of signs of hyperandrogenism 
• Signs of excess androgen in post-pubertal females include: Irregular periods | Hirsutism| Infertility | PCOS | Androgenic alopecia 

Topical Therapies: 

Benzoyl Peroxide 

• Assists with prevention of bacterial resistance and increases efficacy of antibiotics, should be initiated when antibiotics are used 
• Available as cleanser, foams, gels and creams  

Antibiotics 

• Not recommended as monotherapy due to risk of bacterial resistance  
• Clindamycin 1% solution or gel is currently the preferred topical antibiotic for 
  acne therapy 
• Erythromycin may also be used  

Retinoids  

• Vitamin A derivatives  
• Includes: Adapalene | Tretinoin | Tazarotene  
• Tretinoin inactivated by the coadministration of Benzoyl Peroxide so they should be applied at different times of day  
• Use limited by side effects such as drying, peeling and photosensitivity 
• Sunscreen recommended to assist with increased photosensitivity 

Azelaic Acid 

• Good for treatment of post-inflammatory hyperpigmentation 

Dapsone  

• 5% gel recommended for inflammatory acne 
• In studies found to work better in women than in men 

Salicylic Acid  

• Available over the counter in wash off and leave on formulations 
• Limited data on efficacy 

Systemic Antibiotics: 

• Antibiotic use should be limited to shortest possible duration (ideally no more than 3 to 4 months) to reduce risk of antibiotic resistance 
• Switching to topical antibiotics is recommended following oral antibiotic course for maintenance therapy  
• Not recommended as monotherapy 

Tetracyclines 

• First line oral antibiotic class  
• Includes: Doxycycline | Minocycline | Tetracycline 
• Toxicities include: Photosensitivity | GI distress | Pigment deposition (with minocycline) 

Macrolides 

• Should be limited to patients unable to take tetracyclines (e.g., pregnant patients)  
• Includes: Azithromycin | Erythromycin  

Trimethoprim +/- Sulfamethoxazole  

• Generally, not recommended and should be limited to those unable to take tetracyclines or macrolides  

Beta lactams/Cephalosporins 

• Limited data, but used occasionally for patients unable to tolerate any of the above 

Hormonal Agents: 

Combined oral contraceptives  

• Not recommended for certain patients: Pregnant| Breast feeding within 6 weeks of delivery | HTN | Age > 35 and smoker | Diabetes with end organ damage | DM for > 20 years | History of VTE | Heart disease | Prior stroke | Migraines | Liver disease  
• Otherwise, estrogen containing OCPs are effective for menstruating people with inflammatory acne  
• 4 combined OCPs approved by FDA for acne therapy: Ethinyl estradiol/norgestimate | Ethinyl estradiol/norethindrone acetate/ferrous fumarate | Ethinyl estradiol/drospirenone | Ethinyl estradiol/drospirenone/levomefolate 
• Work via an antiandrogen effect  
• May take several months to take effect on acne 

Spironolactone 

• Aldosterone receptor antagonist that decreases testosterone production  
• Recommended for females; male patients had unwanted side effects such as gynecomastia 
• Effect (and side effects) are dose dependent 
• Side effects include: Hyperkalemia | Diuresis | Menstrual irregularities | Breast enlargement | Fatigue | Dizziness 

Flutamide 

• Nonsteroidal selective androgen receptor blocker used in the treatment of prostate cancer; use for acne is not FDA approved  
• High rates of side effects including: Decreased libido | GI distress | Breast tenderness | Hot flashes | Headaches  

Oral corticosteroids  

• Can help temporarily for patients with severe inflammatory acne while initiating other therapies  
• Low dose oral corticosteroids (e.g., Prednisone 5 to 15 mg/day) also recommended for patients with proven adrenal hyperandrogenism  
• Long term use not recommended  

Isotretinoin: 

• Recommended for severe nodular acne or acne associated with scarring and significant psychosocial distress 
• Low dose isotretinoin can be used when side effects limit conventional dosing  
• Should be taken with food  
• Routine monitoring recommended of: CBC | LFTs | Cholesterol | Triglycerides  
• Pregnancy category X: Patients of childbearing age need to be counseled on contraceptive methods 
• Significant side effects, most commonly: Dry skin | Cheilitis | Dry eyes | Peeling  
• Patients should be counseled on risks including| Possible development of IBD | Mood changes (e.g., depression, SI) | Agranulocytosis | Elevated LFTs | Elevated triglycerides 

Miscellaneous and Alternative Therapies: 

Chemical peels 

• Limited evidence for efficacy of routine use of physical modalities 
• Multiple treatments necessary and results not long lasting  

Intralesional steroids  

• Effective for treatment of single nodules  

Tea tree oil, herbal remedies 

• Data limited to support use  

Role of Diet: 

At this time, no dietary changes are recommended for the management of acne 

Glycemic index  

• High glycemic index diets may be associated with acne 

Dairy 

• Some emerging data shows dairy intake may influence acne 

Primary Sources – Learn More: 

Journal of American Academy of Dermatology: Guidelines of Care for the Management of Acne Vulgaris

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

Depressive Disorders: Diagnosis and Treatment  

SUMMARY:

Depressive disorders are characterized by the presence of a sad, empty, or irritable mood and are accompanied by somatic and cognitive changes that significantly impair a person’s ability to function. Depression due to Major Depressive Disorder is a leading cause of disability worldwide, and the leading risk factor for suicide. In the primary care setting up to 18% of patients have depression and about 9% of the US population meet criteria for depression. Many of these patients are not seen by psychiatrists or psychologists and depend on management and screening by their primary care providers.  

SYMPTOMS: 

• Depressed mood most of the day, nearly every day (can be self-reported or based on observation of others) 
• Markedly diminished interest or pleasure in almost all activities most of the day, nearly every day 
• Change in weight or appetite, either increased or decreased 
• Change in sleep patterns, either increased or decreased 
• Psychomotor agitation or retardation 
• Fatigue or loss of energy 
• Feelings of worthlessness or excessive guilt 
• Diminished ability to think, concentrate, or indecisiveness 
• Recurrent thoughts of death, recurrent suicidal ideation with or without a specific plan, or a suicide attempt 

DIAGNOSIS:

Major Depressive Disorder (MDD) 

• Depressed mood OR loss of interest/pleasure AND ≥ 4 additional symptoms from above list 
• Symptoms must be present daily, or nearly every day, during the same 2-week period and represent a change from the previous functioning 
• Symptoms must cause significant distress or impairment in social, occupational, or other areas of functioning. 
• Must not be better explained by schizophrenia spectrum disorder, bipolar disorder or be attributable to substance use or medical conditions 

Persistent Depressive Disorder (PDD) – formerly known as dysthymia  

• Requires a depressed mood AND three or more of the above symptoms for most days for ≥ 2 years 
  • For adolescents, the mood may be irritability and the duration must be ≥1 year 
• Individuals must not be without the symptoms for > 2 consecutive months during the 2 year (or longer) period  
• Must not be better explained by schizophrenia spectrum disorder, bipolar disorder or be attributable to substance use or medical conditions 
• Symptoms must cause significant distress or impairment in some important areas of functioning 

Premenstrual Dysphoric Disorder (PMDD)  

• Requires  
  • ≥ 5 symptoms that are present in the week prior to menses 
  • Occurs in at least 3 consecutive menstrual cycles 
  • Start to improve within a few days after the onset of menses  
  • Become minimal or absent in the week after menses 

• One of the symptoms must be a marked change in mood as described by  
  • Affective lability | Irritability or anger | Depressed mood | Anxiety 

• ≥1 of the following symptoms must be present for a total of 5 symptoms 
  • Decreased interest in usual activities 
  • Difficulty in concentration 
  • Lethargy or lack of energy 
  • Change in appetite or food cravings 
  • Change in amount of sleep 
  • Feeling overwhelmed or out of control 
  • Physical symptoms: e.g., breast tenderness or swelling, join or muscle pain, a feeling of being bloated or weight gain

• Symptoms must cause significant distress or interference with activities and must not be an exacerbation of another disorder. 

 Adjustment Disorder with Depressed Mood 

• Low mood | Tearfulness | Feelings of hopelessness  
• Symptoms occur within 3 months of the onset of an identifiable stressor  
• Symptoms must be severe enough to cause distress outside of what would be expected, or to impair daily functioning  
• Cannot meet criteria for other psychiatric disorder (e.g., MDD) 

Substance/Medication-Induced Depressive Disorder  

• Depressive symptoms associated with the ingestion, inhalation or injection of a substance 
  • Persists beyond the expected length of physiological effects, intoxication or withdrawal period. 

Depressive Disorder Due to Another Medical Condition  

• Prominent and persistent period of depressed mood or diminished interest in activities that predominates the clinical picture 
  • Thought to be related to the direct physiological effects of another medical condition 
  • Commonly associated medical conditions including hypothyroidism, CVA, Parkinson’s disease and Huntington’s disease 

Other Specified Depressive Disorders 

• Recurrent brief depression 
  • Depressed mood and 4 other above symptoms for 2 to 13 days every month for the past 12 months 
  • Not associated with the menstrual cycle  
  • Does not meet criteria for other disorders 

• Short-duration depressive disorder episode 
  • Depressed mood and ≥4 other symptoms for 4 to 13 days 
  • Associated with significant distress or impairment  
  • Does not meet the criteria for other disorders

• Depressive episode with insufficient symptoms 
  • Depressed mood with ≥1 other symptom with significant distress or impairment that persists for ≥2 weeks  
  • Does not meet the criteria for other disorders

• Unspecified Depressive Disorder 
  • Depressive symptoms that cause significant distress or impairment  
  • Does not meet the criteria for any other disorder 

Note: Specifiers for Depressive Disorders 

• With anxious distress 
• With mixed features 
• With melancholic features 
• With atypical features 
• With psychotic features 
• With catatonia 
• With peripartum onset 
• With seasonal pattern 

Screening 

The USPSTF recommends screening for depression in individuals > 12 years of age when there are systems in place to accurately diagnose and effectively treat, and to provide appropriate follow-up. Individuals with depressive disorders should be evaluated for suicide risk and safety planning should be done when appropriate. 

• Common Screening Tools 
  • Patient Health Questionnaire (PHQ-9 and PHQ-2)Patient Health Questionnaire (PHQ-9 and PHQ-2)  
  • Geriatric Depression Scale 
  • Edinburgh Postnatal Depression Scale (EPDS) 

Testing 

• Diagnosis should be made on history according to the DSM-5 criteria listed in the above section | Other diagnosis should be considered based on history and physical exam 

• Lab work can be considered if certain medical conditions are suspected to be contributing (e.g., TSH | RPR | B12 | CBC) 
• Patients should be carefully screened for current or past symptoms of manic episodes as this would change diagnosis and medication treatment 
• Symptoms of psychotic features would affect medication choices 
• Evaluate for medications or substances that may be affecting mood (e.g. Alcohol | Opiates | Beta blockers)  

KEY POINTS 

• Depression is a common and debilitating illness that affects a significant number of patients, most of whom seek help from their primary care providers 
• All adults should be screened for depression via a screening test such as the PHQ-2  
• Treatment depends on severity of symptoms and includes pharmacotherapy, psychotherapy, or a combination of both  

LEARN MORE – Primary Sources 

VA/DoD Clinical Practice Guidelines – Management of Major Depressive Disorder 

 AFP: Common Questions About the Pharmacologic Management of Depression in Adults 

AACP Updates Treatment Guidelines for Adults with Depression – 2023ACP Updates Treatment Guidelines for Adults with Depression – 2023 

Update from the CDC: Practice Guidelines for Prescribing Opioids 

SUMMARY:  

Pain is one of the most common reasons for a patient to visit their doctor, with one study showing roughly 50% of primary care visits related to a pain complaint. Prescriptions for opioids increased over the 1990s and 2000s, peaking in 2012 and decreasing since, though there remain pockets of high opioid dispensing rates scattered throughout America. As opioid use has become more ubiquitous, the death rate from drug overdoses has also increased steadily, with a sharp rise in deaths during the COVID pandemic. In recent years federal and local governments have attempted to address these worrisome trends with improved funding for resources for the treatment of opioid use disorder, and prevention strategies such as guidelines to help clinicians who prescribe opioids. Following the publication of the 2016 CDC guidelines for prescribing opioids, there was a sharp decrease in opioid prescriptions, with the dispensing rate falling to its lowest level in 15 years. The CDC has recently announced updates to its opioid prescribing guideline and has issued 12 key recommendations and 5 guiding principles to aid in implementation.  

Guiding Principles  

• Acute (< 1 month), subacute (1 to 3 months), and chronic pain (> 3 months) should be assessed and treated regardless of whether opioids are part of the treatment regimen 
• Recommendations are voluntary and are intended to be flexible with individualized patient-centered care  
  • Following the 2016 CDC guideline publication there were several studies that demonstrated harm to patients due to provider rigidity over prescribing opioid pain medications, including “untreated and undertreated pain, serious withdrawal symptoms, worsening pain outcomes, psychological distress, overdose, and suicidal ideation and behavior” 

• Use a multimodal and multidisciplinary approach to pain management including behavioral health and social support systems  
• Avoid misapplying the guideline beyond its intended use or implementing policies derived from the guideline that may lead to harm or untreated pain  
• Clinicians and health systems should be especially vigilant regarding healthcare inequities in prescribing pain medications 
  • Groups with highest rate of death from drug overdose: American Indian men | Alaska Native men | Black men 
  • In one study examining Medicare beneficiaries with disability, the annual prevalence of prescription opioid receipt was similar among Black and White patients, but Black patients received 36% fewer MME (Morphine Milligram Equivalent).

Tap Here to See MME Calculator

Note: The CDC excludes certain groups from the below recommendations, including those below the age of 18, and pain management related to sickle cell disease, cancer-related pain treatment, palliative care, and end-of-life care.  

Key Recommendations  

Initiating Opioids for Pain 

• Prior to prescribing any opioids 
  • Clinicians should review the patient’s history of opioid use via the state prescription drug monitoring program (PDMP) 

Acute Pain 

• Nonopioid therapies are at least as effective as opioids for many common types of acute pain  

• Nonopioid pharmacologic and nonpharmacologic therapies should be maximized prior to initiating opiates for acute pain  
• Opioids for acute pain should only be given when benefits outweigh risks  
• Risks of opioid use and possible benefits should be discussed with patient  
• Acute Pain conditions where nonopioid therapy has been shown to be as effective include 
  • Low back pain | Neck pain | Minor MSK injuries | Minor surgeries | Kidney stones | Migraine  

• Nonpharmacologic therapies include 
  • Ice | Heat | Elevation | Rest | Immobilization | Exercise | Massage 

• Nonopioid Pharmacologics include 
  • Tylenol | NSAIDs | Menthol gel | Triptans | Muscle relaxants  

Subacute and Chronic Pain  

• Nonopioid therapies are preferred for subacute and chronic pain  
• Maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate  
• Consider initiating opioid therapy if benefits outweigh risks  
• Discuss risks and benefits with patient 
  • Establish treatment goals | Make a plan to discontinue if benefits don’t outweigh the risks  

• Nonpharmacologic therapies include  
  • Physical therapy | Weight loss | Psychological therapy | Spinal manipulation | Low-level laser therapy | Massage | Acupuncture | Cognitive behavior therapy | Mindfulness practices  

• Nonopioid Pharmacologics include Topical NSAIDS | SNRIs | Tricyclics | Gabapentin | Pregabalin | Capsaicin | Lidocaine patches  

NSAID Use 

NSAIDs should be used at the lowest effective dose and shortest duration needed and should be used with caution, particularly in older adults and in patients with cardiovascular comorbidities, chronic renal failure, or previous gastrointestinal bleeding 

Opioid Drug and Dose Selection 

• When starting opioids for all pain types (Acute | Subacute | Chronic), begin with immediate release formulations  
  • Extended release/long-acting (ER/LA) opioids should be reserved for severe, continuous pain  
  • Some ER/LA opioids should be reserved for opioid-tolerant patients (Methadone | Fentanyl) 

• Initiate the immediate release opioids at the lowest effective dosage for opioid-naïve patients  
  • Approximately 5 to 10 MME or a daily dosage of 20 to 30 MME/day  

• If opioids are continued use caution  
  • Carefully evaluate individual benefits and risks when considering increasing dosage 
  • Avoid increasing dosage above levels likely to yield limited benefits with greater risks  
  • Doses ≥ 50 MME/day yield diminishing returns and progressively increasing risks which should be discussed with patient and carefully considered 

• Once on opioid therapy, clinicians should carefully weigh benefits and risks when changing opioid dosage 
• Patients who are at higher risk for adverse events 
  • Sleep apnea | Hepatic dysfunction | CKD/ESRD | Pregnancy | Substance use disorder | >65 years | Work in Safety Critical Jobs | Mental health disorders | Prior overdose 

• If benefits do not outweigh risks of continued opioid therapy, optimize other therapies while working to gradually taper to lower dosages or appropriately taper and discontinue opioids 
• Patient agreement is vitally important for a successful taper 

• Reasons to taper include  
  • Patient request | Pain has improved and underlying cause may have resolved | Misuse | Development of comorbidities that increase risks from opioid use | Side effects diminish quality of life | Side effects impair function | Ongoing therapy has not improved pain | Overdose or serious adverse event has occurred  

• Tapers of approximately 10% per month or slower are likely to be better tolerated when patients have been taking opioids for longer durations (≥ 1 year)  
• Tapers of 10% per week may be tolerated for those on opioids for shorter durations (weeks to months)   
• Do not abruptly discontinue or rapidly reduce to low doses unless there are indications of a life-threatening issue such as concern for impending overdose (e.g., confusion, sedation, slurred speech) 
  • Risks of abrupt withdrawal of opiates include: Acute withdrawal symptoms | Exacerbation of pain | Serious psychological distress | Suicidal ideation 

Duration and Follow Up 

Acute Pain 

• Prescriptions dispensed for acute pain should contain only enough opioids for the expected duration of pain severe enough to require opioids 
  • For many causes of acute pain an initial opioid prescription of 4 to 7 days’ duration is sufficient 
  • Reevaluate and rule out other causes of pain if patient continues to need opioids for >2 weeks for acute pain

Subacute and Chronic Pain 

• Reevaluate benefits and risks with patients within 1 to 4 weeks of starting or adjusting dosage of opioid therapy   
• Interval for follow up after initiating or adjusting opioids should be shorter if  
  • Receiving > 50 MME/day | Starting methadone | Starting ER/LA opioids  

• For patients on long term opioids follow up is recommended at least every 3 months  

Risk Assessment

• Periodically during follow up 
  • Rediscuss risks of opioids with patient | Check PDMP to review dosages of opioids received | Discuss strategies to mitigate risk | Offer Naloxone (FDA approved OTC Naloxone spray March 2023) 

• Consider using toxicology testing annually “to assess for prescribed opioids and other prescription and nonprescription controlled substances that increase risk for overdose when combined with opioids” 
  • Results should be used in a non-punitive manner and testing discussed prior to being undertaken with the patient 

• Use caution when prescribing opioid pain medication and benzodiazepines together  
  • Consider tapering off benzos prior to initiating opioids  

• Offer or arrange treatment with evidence-based medications to treat patients with opioid use disorder 
• Opioid use disorder definition 
  • Defined by the DSM-5 (see ‘Primary Sources – Learn More’ below)   

• FDA approved medication for opioid use disorder include 
  • Buprenorphine| Methadone | Naltrexone

Primary Sources – Learn More: 

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 

HHS Overdose Prevention Strategy  

Recent surge in U.S. drug overdose deaths has hit Black men the hardest 

Racial and Ethnic Disparities in Drug Overdose Deaths in the US During the COVID-19 Pandemic 

Racial Inequality in Prescription Opioid Receipt — Role of Individual Health Systems 

Naloxone Prescribing Information  

FDA Approves First OTC Naloxone Spray 

ACP Guideline: Colonoscopy and Interventions to Prevent Recurrence Following Left-Sided Diverticulitis

Summary: 

Diverticula are sac-like protrusions of the colonic wall that tend to occur at increasing rates with older age, with an estimated 50% of adults over the age of 60 developing diverticula. Diverticulosis is defined as the presence of diverticula, and 5 to 10% of patients with diverticulosis will go on to develop symptomatic disease such as diverticulitis, recurrent pain, and bleeding. Following an episode of diverticulitis, a recurrence will occur in 8% to 36% of patients at 1 to 10 years. Additionally, patients who present with complicated diverticulitis – or diverticulitis associated with abscess, bleeding, obstruction, fistula or perforation – have a higher prevalence of colorectal cancer that may be misdiagnosed or missed on initial imaging.  The ACP has put together recommendations regarding follow up care after an episode of left-sided diverticulitis given these increased risks.  

Definitions: 

Uncomplicated Diverticulitis 

• Left lower quadrant abdominal pain and change in bowel habits associated with localized inflammation of diverticula 
• No signs or symptoms of sepsis  
• Immunocompetent patients  

Complicated Diverticulitis  

• Diverticulitis with at least one of the following: Perforation | Bleeding | Obstruction | Abscess/Phlegmon | Fistula | Immunosuppressed patient  

Colonoscopy for Diagnostic Evaluation: 

“ACP suggests that clinicians refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis in patients who have not had recent colonoscopy” 

• Evidence is inconclusive on whether there is a net benefit in obtaining colonoscopy following uncomplicated diverticulitis  
• Evidence is also inconclusive on whether there is improved CRC mortality with colonoscopy following complicated diverticulitis  
• Despite this, ACP recommends colonoscopy following complicated diverticulitis in patients with no recent colonoscopy to rule out CRC given that CRC may present with similar signs and symptoms to complicated diverticulitis  

• Colonoscopy should be obtained at least 6 to 8 weeks after resolution of diverticulitis  
• ACP does not define “recent colonoscopy”, but they do not recommend colonoscopy for patients who are otherwise up to date on their CRC screening  
• Colonoscopy may be most beneficial for those at higher risk of CRC: Older age | Malnutrition | Weight loss | Change in bowel habits | Bloody stool | Persistent abdominal pain  

Interventions to Prevent Recurrence: 

“ACP recommends against clinicians using mesalamine to prevent recurrent diverticulitis” 

• Diverticulitis is believed to be an inflammatory process, so there was interest in using anti-inflammatory medications to prevent recurrence 
• Studies reviewed showed no benefit and more discontinuation of drug due to adverse events with mesalamine use  

Dietary Interventions 

• ACP did not review studies on dietary therapies (e.g. high fiber diet) for reduction of recurrent diverticulitis  

• A large study in 2008 demonstrated no increased risk for diverticulitis with a diet including nuts, corn, and popcorn, despite the persistence of this belief in the medical community (see  
  Primary Sources – Learn More below)  

“ACP suggests that clinicians discuss elective surgery to prevent recurrent diverticulitis after initial treatment in patients who have either uncomplicated diverticulitis that is persistent or recurs frequently or complicated diverticulitis. The informed decision whether to undergo surgery should be personalized based on a discussion of potential benefits, harms, costs, and patient’s preferences” 

• Elective surgery should not be offered to patients with uncomplicated diverticulitis that is not persistent or recurring  
• Discussion of surgery should include potential harms as 1.4% to 5.5% of surgical patients develop post-op complications (e.g. anastomotic leak, sepsis, MI)  
• There is no minimum number of recurrences necessary for surgery and discussion should be tailored to the individual patient  

• Evidence did show decreased rate of recurrent diverticulitis with surgery for patients with: 
  • Complicated or uncomplicated diverticulitis with long term symptoms following acute episode (> 3 months of symptoms)  
  • Complicated or uncomplicated diverticulitis with high rate of recurrence (> or = 3 over 2 years)  

Primary Sources – Read More  

Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis: A Clinical Guideline From the American College of Physicians 

Nut, corn, and popcorn consumption and the incidence of diverticular disease 

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:

• To view all specific recommendations of the USPSTF leave all search criteria blank and simply click “Submit”
• All fields are optional
• When using this tool please read the specific recommendation to determine if the preventive service is appropriate for your patient
• The “Update Recommendations” button is located below the “Reset” button

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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)
• Screening for hepatitis B (HBV) should include all adults aged 18 years and older
  • At least once in their lifetime using a triple panel test
  • Screen pregnant people for hepatitis B surface antigen (HBsAg) during each pregnancy regardless of vaccination status and history of testing
  • Expand periodic risk-based testing to include people incarcerated, people with a history of sexually transmitted infections or multiple sex partners, and people with hepatitis C virus infection
  • Test anyone who requests HBV testing regardless of disclosure of risk
• Screening for hepatitis C infection (HCV) should 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
• CDC has updated guidelines to recommend universal hepatitis C and hepatitis B screening in all adults

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

CDC: Screening and Testing Recommendations for Chronic Hepatitis B Virus Infection (HBV)

USPSTF: Screening for Hepatitis B Virus Infection in Adolescents and Adults

Map: Prevalence of hepatitis B virus infection

USPSTF: Screening for Chlamydia and Gonorrhea

USPSTF: Serologic Screening for Genital Herpes Infection: US Preventive Services Task Force Recommendation Statement

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:  

FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease

Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular morbidity over 10 years in the CLARICOR randomised, blinded clinical trial 

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.

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• COVID-19 Categories 
• Symptoms
• Those at Risk

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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

• 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:

Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Providers

NIH: Clinical Spectrum | COVID-19 Treatment Guidelines

Impact of SARS-CoV-2 Delta variant on incubation, transmission settings and vaccine effectiveness: Results from a nationwide case-control study in France (Lancet Regional Health, 2022)

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

FDA: Coronavirus Disease 2019

BMJ: Coronavirus Updates

Lancet: Coronavirus Hub

NEJM: 2019 Novel Coronavirus

Annals of Internal Medicine: Content Related to Coronavirus in Annals of Internal Medicine

JAMA: What Is a Pandemic?

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 

Subcutaneous injections of aluminum at vaccine adjuvant levels activate innate immune genes in mouse brain that are homologous with biomarkers of autism

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 

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120 to 129 mmHg and <80 mmHg: ELEVATED BP

• Healthy lifestyle changes  

• Reassess in 3 to 6 months  

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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 

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≥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:

Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults – A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

Screening for Hypertension in Adults: US Preventive Services Task Force Reaffirmation Recommendation Statement

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

2019 AHA/ACC Clinical Performance and Quality Measures for Adults With High Blood Pressure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures

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 < 14 days
  • 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 

Doxycycline for outpatient-treated acute exacerbations of COPD: a randomised double-blind placebo-controlled trial 

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)

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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

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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 3^rd 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
• 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  

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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

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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

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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 

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PREVENTATIVE TREATMENT

• Consider preventative treatment
  • When ≥ 8 headache days/month or ≥4 migraines/month
  • For patients with chronic migraine

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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 

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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

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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

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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

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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

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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

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Learn More – Primary Sources

Lancet: Migraine

Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition (2018).

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 MMWR: Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease — United States 

CDC: Lyme Disease Diagnosis, Treatment and Testing

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease

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

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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)

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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:

Lancet: Migraine

Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition (2018).

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)

Risk Enhancers

Statin Therapy

Statin Side Effects

USPSTF and Statin Use

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%
• 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

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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)

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

2018 AHA/ACC/AACVPR/AAPA/ABC/ ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

American College of Cardiology Foundation: 2018 Guideline on the Management of Blood Cholesterol GUIDELINES MADE SIMPLE: A Selection of Tables and Figures

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

USPSTF: Recommendation: Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication

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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
• 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:

Guideline: The American Thoracic Society and Infectious Diseases Society of America provide recommendations for the diagnosis and treatment of adults with community-acquired pneumonia.

American Thoracic Society: Nucleic Acid–based Testing for Noninfluenza Viral Pathogens in Adults
with Suspected Community-acquired Pneumonia

Outpatient vs. Inpatient Treatment of Community-Acquired Pneumonia: PSI and CURB-65 Scoring Models

QXMD PSI Calculator

CDC: Pneumococcal Disease

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:

GOLD Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, 2020 Report

GOLD Pocket Guide to COPD Diagnosis, Management, and Prevention: A Guide for Health Care Professionals

6 Minute Walk Distance

mMRC (Modified Medical Research Council) Dyspnea Scale

COPD Assessment Test (CAT)

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:

Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association

Use of Dual Antiplatelet Therapy Following Ischemic Stroke (Dong et al, Stroke 2020)

Optimal Blood Pressure After Intracerebral Hemorrhage: Still a Moving Target (Rabinstein, Stroke 2018)

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

Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections: 2014 Update by the Infectious Disease Society of America

NICE Guideline: Cellulitis and erysipelas: antimicrobial prescribing (2019)

Appropriate Use of Short-Course Antibiotics in Common Infections: Best Practice Advice From the American College of Physicians (2021)

CDC: Cellulitis

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 

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

Asthma Control Test (ACT)

American Thoracic Society: Asthma Center

Diagnosing Allergic Bronchopulmonary Aspergillosis: A Review

Asthma: The Stepwise Approach to Treatment

Table of Contents

• Reducing Impairment
• Reducing Risk
• Treatment
• Managing Acute Exacerbations
• Monitoring

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 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  
• 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

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

Global Initiative for Asthma

CDC: Asthma Resources for Healthcare Professionals

Asthma Control Test (ACT)

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:

Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. An Official American Thoracic Society Clinical Practice Guideline

Varenicline Drug Information 

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.