How Does Myocarditis Risk with COVID-19 Vaccination Compare to Risk associated with SARS-CoV-2 Infection?
BACKGROUND AND PURPOSE:
- Patone et al. (Nature Medicine, 2021) examined the associations between the first and second dose of AstraZeneca, Pfizer or Moderna vaccines and cardiac adverse events
METHODS:
- Cohort study
- Between December 2020 and August 2021
- English National Immunisation (NIMS) Database of COVID-19 vaccination to national data for mortality, hospital admissions and SARS-CoV-2 infection data
- Population
- Individuals ≥16 years who received ≥1 vaccine dose
- Admitted to the hospital or died from the outcome of interest
- Exposure
- First or second dose of AstraZeneca, Pfizer, or Moderna vaccine
- SARS-CoV-2 infection
- Study design
- The authors calculated risk of primary outcomes at prespecified time periods following exposure
- Primary outcomes
- Myocarditis
- Pericarditis
- Arrythmia
RESULTS:
- Received ≥1 dose of vaccine: 38,615,491
- AstraZeneca (ChAdOx1): 20,615,911 | Pfizer (BNT162b2): 16,993,389 | Moderna (mRNA-1273): 1,006,191
- SARS-CoV-2 infection: 3,028,867
- Myocarditis events: 1615
- Over the 1-to-28-day postexposure period, there was an increased risk of myocarditis associated with
- The first dose of AstraZeneca
- Incidence rate ratio (IRR) 1.29 (95% CI, 1.05 to 1.58)
- The first dose of Pfizer
- IRR 1.31 (95% CI, 1.03 to 1.66)
- The first AND second dose of Moderna
- IRR 2.97 (95% CI, 1.34 to 6.58)
- IRR 9.84 (95% CI, 2.69 to 36.03)
- SARS-CoV-2 infection
- IRR 9.76 (95% CI, 7.51 to 12.69)
- The first dose of AstraZeneca
- Estimate of absolute cases of extra myocarditis events in 1 to 28 days postexposure, per 1 million people
- AstraZeneca first dose: 2 events (95% CI, 0 to 3)
- Pfizer first dose: 1 event (95% CI, 0 to 2)
- Moderna first dose: 6 events (95% CI, 2 to 8)
- Moderna second dose: 10 events (95% CI, 7 to 11)
- SARS-CoV-2 infection: 40 events (95% CI, 38 to 41)
- Other cardiac events
- COVID-19 vaccination was not associated with an increased risk of other cardiac events, except an increased risk of arrhythmia following a second dose of Moderna
- The risks for pericarditis and cardiac arrhythmias were higher following a positive SARS-CoV-2 test
- Subgroup analyses showed an increased risk of myocarditis associated with the mRNA vaccines only in those <40 years
CONCLUSION:
- COVID-19 vaccination is associated with an increased risk of myocarditis
- However, the risk of myocarditis with vaccination is less than the risk associated with SARS-CoV-2 infection itself
- SARS-CoV-2 infection is also associated with increased risk of pericarditis and arrythmias, while vaccination is not
- The authors state
…the mRNA-1273 vaccine roll-out began in April 2021 in the United Kingdom; as a consequence, the number of events in patients who received this vaccine was low
Although the signal associated with myocarditis is strong for this vaccine, care is needed in the interpretation, and it would be useful to replicate our results in similarly large datasets internationally
Learn More – Primary Sources:
Does COVID-19 Vaccination Protect Against Heart Attack and Stroke Following Infection?
BACKGROUND AND PURPOSE:
- It is unclear whether COVID-19 vaccines prevent secondary complications of COVID (e.g. acute myocardial infarction (AMI) and ischemic stroke) in those who do become infected despite vaccination
- Kim et al. (JAMA, 2022) examined the association between vaccination and AMI and ischemic stroke after COVID-19 infection
METHODS:
- Retrospective cohort study
- Korean nationwide registry
- Population
- Adults who were diagnosed with COVID-19, including asymptomatic infections, between July 2020 and December 2021
- Exposure
- Full vaccination (2 doses of mRNA or viral vector vaccine)
- Never vaccinated
- Study design
- Logistic regression and Cox proportional hazards modeling used, with adjustment for age, sex, Charlson Comorbidity Index, hypertension, and insurance type
- Primary outcome
- Composite of hospitalizations for AMI and ischemic stroke that occurred 31 to 120 days after COVID-19 diagnosis
RESULTS:
- Never vaccinated: 62,727 | Fully vaccinated: 168,310
- Fully vaccinated cohort
- Was older and had more comorbidities
- Had fewer cases of severe or critical COVID-19
- Fully vaccinated cohort
- Incidence of composite outcome
- Unvaccinated: 6.18 per 1,000,000 person-days
- Fully vaccinated: 5.49 per 1,000,000 person-days
- Adjusted risk using hazard ratio (HR) of the composite outcome was significantly lower in the fully vaccinated group
- aHR 0.42 (95% CI, 0.29 to 0.62)
- Adjusted risk was significantly lower in fully vaccinated patients for both
- AMI: aHR 0.48 (95% CI, 0.25 to 0.94)
- Ischemic stroke: aHR 0.40 (95% CI, 0.26 to 0.63)
CONCLUSION:
- Compared to no vaccination, full COVID-19 vaccination was associated with a reduced risk for acute myocardial infarction and ischemic stroke in individuals who become infected
- The authors state
A lower risk for outcome events in fully vaccinated patients was observed in all subgroups, although some did not reach statistical significance, including those with severe or critical infection
Learn More – Primary Sources:
Long-Term Sperm Health Remains Unaffected by COVID-19 Vaccination
BACKGROUND AND PURPOSE:
- Concerns about impact on fertility are frequently cited among those hesitant to receive the COVID-19 vaccine
- Diaz et al. (F&S Reports, 2022) updated their previous study to assess the long-term impact of COVID-19 vaccination on male fertility potential
METHODS:
- Single center prospective follow-up study
- Participants
- Healthy male volunteers
- Between the ages of 18 and 50 years
- Received 2 doses of an mRNA COVID-19 vaccine and participated in the previous survey at 3 months post-vaccination
- Exposures
- Time since vaccination (baseline, 3 months, 9+ months)
- Study design
- Semen was collected 9 months post-vaccination and assessed for volume, sperm concentration, motility, and total motile sperm count (TMSC)
- Primary outcome
- Median change in TMSC at the different exposure time points following vaccination
RESULTS:
- 12 men
- Median age: 26 (IQR, 25 to 30) years
- Median time since second vaccination dose: 10 months
- Received a booster: 50%
- Had a history of COVID-19: 33%
- There was no difference in TMSC at baseline, 3 months, and 9+ months (P=0.519)
- Baseline: median 31 (IQR, 4 to 51.3) million
- 3 months: median 33 (IQR, 13.5 to 85) million
- 9+ months: median 37.5 (IQR, 8.5 to 117.8) million
- There were no significant differences in any of the sperm parameters at any time point
CONCLUSION:
- There were no long-term (9+ months) significant differences in sperm parameters following mRNA COVID-19 vaccination
- The authors state
A plausible explanation for this maintenance of semen parameters may be due to the mechanism of the mRNA vaccine, lack of live virus, and its inability to alter an individual’s DNA
In addition, the apparent absence of mRNA localization to the gonads is most likely in part due to the blood testis barrier
Learn More – Primary Sources:
Long-Term Evaluation of Sperm Parameters Following COVID-19 mRNA Vaccination
Remdesivir Emergency Authorization: FDA Update and Summary of Preliminary NIH Study Data
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
The FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The approval is based on the NIH’s clinical trial showing “promising results.”
- An EUA is different than a full FDA approval
- An EUA is based on an FDA evaluation of evidence and risks vs potential or known benefits of of “unproven” products during an emergency
- The FDA states
The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease
Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator
It was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use
KEY POINTS:
NIH Remdesivir Trial
- RCT involving 1063 patients:
- Adaptive COVID-19 Treatment Trial (ACTT)
- Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID)
- Multicentered (including US, UK, and Singapore)
- Started in February 2020
- Current primary endpoint: Being well enough for hospital discharge or returning to normal activity level
Preliminary Data
- Time to recovery
- Median time to recovery: 11 days for remdesivir group vs 15 days for placebo group
- 31% faster time to recovery in remdesivir group vs placebo (p<0.001)
- Mortality Rate
- 8.0% in remdesivir group vs 11.6% for the placebo group (p=0.059)
- “Suggests benefit” but not statistically significant
- Second (next) stage of trial
- Remdesivir in combination with another agent | Likely to be a janus kinase inhibitor
- One of the investigators (UK team) stated (April 30, 2020)
As far as the results are concerned, it’s cautious optimism
There is some effect but it is not a wonder effect
We have to find out when is the best time to give this drug, who benefits more
There is still a lot of data to come out of this trial
Learn More – Primary Sources:
NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19
Covid-19: Remdesivir is helpful but not a wonder drug, say researchers (BMJ)
How Effective is the Bivalent COVID Booster?
BACKGROUND AND PURPOSE:
- Tenforde et al. (CDC MMWR, 2022) assessed the effectiveness of the updated bivalent mRNA COVID-19 vaccine boosters (containing mRNA targeting Omicron lineages of SARS-CoV-2) at preventing COVID-19 medical encounters
METHODS:
- Cohort study
- Multistate VISION Network (See ‘Learn More – Primary Sources’ below)
- Population
- Immunocompetent adults aged ≥18 years
- Emergency department/urgent care (ED/UC) encounter or hospitalization for a COVID-19–like illness
- Exposure
- Unvaccinated: No vaccination
- Monovalent only: Vaccinated with 2, 3 or 4 doses of a monovalent-only mRNA vaccine
- Mono + Bivalent: Vaccinated with 2, 3, or 4 monovalent doses plus a bivalent booster dose ≥60 days after receipt of their last monovalent dose
- Study design
- Multivariable logistic regression was used to calculate odds ratios, with adjustment for age, race and ethnicity, sex, calendar day, geographic region and SARS-CoV-2 circulation
- Primary outcome
- Vaccine effectiveness (VE) against ED/UC encounters and hospitalizations
RESULTS:
- ED/UC patients COVID-19 positive: 9009 | ED/UC patients COVID-19 negative: 69,294
- Unvaccinated: 31%
- Mono + Bivalent: 5%
- VE of a bivalent booster dose (after 2, 3, or 4 monovalent doses) against ED/UC encounters was
- Compared to no vaccination: 56%
- Compared to monovalent only vaccination with last dose 2 to 4 months earlier: 31%
- Compared to monovalent only vaccination with last dose ≥11 months earlier: 50%
- VE of a bivalent booster dose (after 2, 3, or 4 monovalent doses) against hospitalizations was
- Compared to no vaccination: 57%
- Compared to monovalent only vaccination with last dose 5 to 7 months earlier: 38%
- Compared to monovalent only vaccination with last dose ≥11 months earlier: 45%
CONCLUSION:
- During September to November 2022, when the BA.5 and other Omicron sublineages were predominant, bivalent COVID-19 vaccine was effective at preventing patients from requiring medical care for COVID-19 infection compared to monovalent vaccine or no vaccine
- The authors state
These findings support efforts to improve coverage with bivalent vaccines, although optimal timing for receipt of bivalent vaccine booster doses needs to be established
Learn More – Primary Sources:
CDC Guidance on COVID-19 and Asthma
SUMMARY:
The CDC does include asthma on the list of comorbidities that place individuals at higher risk for severe COVID-19 illness. The following provides a summary of key highlights regarding management of patients with asthma during the pandemic. The CDC cites that these recommendations are in accordance with other national organizations including national professional organizations, such as the American Academy of Allergy, Asthma & Immunology (AAAAI), American College of Allergy, Asthma & Immunology (ACAAI), Allergy & Asthma Network (AAN) and the Asthma & Allergy Foundation of America (AAFA). It is important to note that SARS-CoV-2 infection can trigger an exacerbation of asthma
Daily Asthma Preventive Therapy
- Choice of therapeutics for daily asthma preventive therapy has not been affected by the pandemic
- Patients using inhaled steroids
- CDC emphasizes importance of continuing inhaled corticosteroids
- No evidence of increased risk of COVID-19 morbidity
- Strong evidence demonstrating reduced risk of asthma exacerbation with maintenance of asthma controller therapy
- Nebulizer treatments
- If no symptoms or COVID-19 diagnosis, continue any required nebulizer treatments
Asthma Exacerbation
- Choice of therapeutics for asthma exacerbations has not been affected by the pandemic
- Systemic corticosteroids
- Should be used to treat an asthma exacerbation as per current standards of care, even if it is caused by COVID-19
- No evidence to suggest that short-term use for asthma exacerbations will increase risk for severe COVID-19
- Strong data to support use of systemic steroids for moderate or severe asthma exacerbations
- Test for SARS-CoV-2 if concern that exacerbation is caused by underlying COVID-19
If Patient is Positive for COVID-19
Nebulizer Use
- Use nebulizer in a location
- That minimizes and preferably avoids exposure to other household members
- Where air is not recirculated into the home such as
- Porch | Patio | Garage
- Limit number of people where the nebulizer is used
- Clean nebulizers according to the manufacturer’s instructions
Note: If patient symptomatic or has COVID-19, healthcare professionals who need to be present during nebulizer treatment should use CDC’s recommended precautions when performing aerosol-generating procedures
Differentiating Asthma Exacerbation from COVID-19
Exacerbation of Asthma
- History
- Wheeze
- Symptoms improve with inhaler
- Diurnal variation
- No fever
- Coexisting hay fever symptoms
- Examination
- Wheeze
- Peak expiratory flow: Reduced
COVID-19
- History
- Ask about close contact with known or suspected case
- Fever and flu like symptoms (fatigue, headache, myalgia)
- Dry continuous cough
- Symptoms do not improve with inhaler
- Timing of dyspnea usually 4 to 8 days after symptom onset
- Examination
- No wheeze
- Peak expiratory flow: May be normal
Learn More – Primary Sources:
CDC for Healthcare Professionals: Clinical Questions about COVID-19
NIH: Asthma Management Guidelines: Focused Updates 2020
Assessment and management of adults with asthma during the covid-19 pandemic (BMJ)
COVID-19: Category Definitions, Symptoms and Those at Increased Risk
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date. This summary has been updated with the latest CDC guidelines on when to end quarantine.
SUMMARY:
The novel coronavirus, named SARS-CoV-2, is the pathogen underlying the pandemic (a global outbreak of disease). The disease associated with this virus has been officially named COVID-19. Coronaviruses represent a large family of viruses. They can cause human illness, but many are found in animals and, rarely, animal coronaviruses can evolve and infect people as was the case in previous infectious outbreaks such as MERS and SARS.
COVID-19 Categories (NIH Panel)
- Asymptomatic or pre-symptomatic infection
- Test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test)
- No symptoms that are consistent with COVID-19
- Mild illness
- Have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell)
- No shortness of breath, dyspnea, or abnormal chest imaging
- Moderate illness
- Evidence of lower respiratory disease during clinical assessment or imaging and oxygen saturation (SpO2) ≥94% on room air at sea level
- Severe illness
- SpO2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, a respiratory rate >30 breaths/min, or lung infiltrates >50%
- Critical illness
- Respiratory failure, septic shock, and/or multiple organ dysfunction
Note: SpO2 is a key parameter for defining the illness categories listed above | Pulse oximetry has important limitations (e.g., skin pigmentation, thickness or temperature) | Clinicians who use SpO2 when assessing a patient must be aware of those limitations and conduct the assessment in the context of that patient’s clinical status
Pregnancy: Oxygen supplementation in pregnancy generally used when SpO2 <95% on room air at sea level to accommodate the physiologic needs of mother and fetus
Symptoms
- Incubation period
- 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)
- Down syndrome
- Limitations with self-care or activities of daily living
- Learning Disabilities
- Spinal Cord Injuries
- See ‘Learn More – Primary Care’ CDC reference that includes extensive list for included disabilities
- 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
- Overweight (BMI ≥25 kg/m2, but <30 kg/m2)
- Sickle cell disease
- Substance use disorders
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*
- Thallassemia
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:
CDC: Clinical Presentation | Clinical Care Considerations
CDC Coronavirus Disease 2019: Overview of Testing for SARS-CoV-2
Clinical Questions about COVID-19: Questions and Answers
WHO: Novel coronavirus Information Page
JAMA: Coronavirus Disease 2019
Annals of Internal Medicine: Content Related to Coronavirus in Annals of Internal Medicine
HPV Vaccine Recommendations Including Guidance for Ages 27 to 45
SUMMARY:
The most recent evidence-based HPV vaccine recommendations address when to administer the vaccine and dosing. One area that has elicited more recent guidance focuses on whether to offer the HPV vaccine to individuals over the age of 26.
- The FDA (October 2018) extended approval of HPV vaccine to individuals age 27 to 45 years
- ACIP (June 2019) voted to
- Expand routine and catch-up HPV vaccination in males through 26 years of age who are inadequately vaccinated
- Offer HPV vaccine to individuals age 27 to 45 years who have not been adequately vaccinated based on shared clinical decision making
- ACIP published their final recommendations (August 2019) in the CDC’s Morbidity and Mortality Weekly Report
Children and adults aged 9 through 26 years: HPV vaccination is routinely recommended at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated.
Adults aged >26 years: Catch-up HPV vaccination is not recommended for all adults aged >26 years. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated. HPV vaccines are not licensed for use in adults aged >45 years.
These recommendations for children and adults aged 9 through 26 years and for adults aged >26 years apply to all persons, regardless of behavioral or medical risk factors for HPV infection or disease.
For persons who are pregnant, HPV vaccination should be delayed until after pregnancy; however, pregnancy testing is not needed before vaccination.
Persons who are breastfeeding or lactating can receive HPV vaccine. Recommendations regarding HPV vaccination during pregnancy or lactation have not changed.
- ACIP suggests considering the following points for shared-decision making with adults who are 27 to 45 years of age
- HPV is very common, usually transient and asymptomatic
- Although typically acquired in young adulthood, some adults are at risk for acquiring new HPV infection
- A new sex partner is a risk factor, while those in long-term, mutually monogamous partnerships are not likely to acquire a new HPV infection
- HPV types: Sexually active adults will likely have been exposed to some HPV types, but not all HPV types are vaccine targets
- There is no antibody test to determine immunity
- HPV vaccine has high efficacy in persons not yet exposed to vaccine-type HPV
- Lower vaccine effectiveness may be expected in those with HPV risk factors
- Multiple lifetime sex partners | Previous infection with vaccine-type HPV | immunocompromising conditions
- HPV vaccines are prophylactic only and can’t prevent infection progression, improve time to clearance or treat HPV-related disease
- In summary, the CDC states
For adults aged 27 years and older, clinicians can consider discussing HPV vaccination with people who are most likely to benefit. HPV vaccination does not need to be discussed with most adults over age 26 years
CDC Dosing Schedule
- <15 years: 2 doses spaced 6 to 12 months apart
- ≥15 years: 3-dose schedule
- Initial dose
- Second dose at 1 to 2 months after initial
- Third dose at 6 months after initial
Updated ACOG HPV vaccine recommendations
- Routine HPV vaccination is recommended for females and males
- Target age is 11 to 12 years but can be given through age 26
- Can be given from age of 9
- Do not test for HPV DNA prior to vaccination
- Vaccinate even if patient was tested and is HPV DNA positive
- If not vaccinated between 11 to 12 years
- Vaccinate between 13 to 26 years (catch up period)
- Offer regardless of sexual activity, prior exposure to HPV, or sexual orientation
- Women 27 to 45 years and previously unvaccinated
- Use shared clinical decision making
- ACOG “does not recommend that an individual who received the quadrivalent HPV vaccine be revaccinated with 9-valent HPV vaccine, including those aged 27 to 45 years who previously completed some, but not all, of the vaccine series when they were younger”
- Pregnancy
- HPV vaccine is not recommended during pregnancy
- Pregnancy testing prior to HPV vaccination not recommended
- If vaccination schedule is interrupted by pregnancy, resume postpartum with the next dose
- HPV vaccine can and should be given to breastfeeding women ≤26 who have not been vaccinated
- The CDC encourages pregnant patients and healthcare professionals to report to the manufacturer and VAERS system if vaccine was administered during pregnancy | How and where to report is described in “CDC: HPV Vaccine Safety” in Learn More-Primary Sources below
- Counsel to expect mild local discomfort and that this is not a cause for concern
- Watch adolescents for at least 15 minutes following vaccination due to risk of fainting in this population
AAP
- The AAP has also endorsed the CDC HPV recommendations
- The HPV vaccine should be normalized as a standard of care
- Recommendation should be clear and unambiguous
- AAP provides multiple strategies (see ‘Learn More – Primary Sources’ below) to engaging with patients including focusing on cancer prevention benefits for all children
ACS
- The ACS endorses ACIP CDC guidance regarding HPV guidance except for the approach to take with individuals who are 27 to 45 years and not adequately vaccinated
The ACS does not endorse the 2019 Advisory Committee on Immunization Practices recommendation for shared clinical decision making for some adults aged 27 through 45 years who are not adequately vaccinated because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit
Adjuvant HPV Vaccine to Prevent CIN Recurrence
- ACOG recommends considering adjuvant HPV vaccine for unvaccinated individuals 27 to 45 years who are undergoing treatment for CIN 2+
Learn More – Primary Sources:
ACOG Committee Opinion 809: Human Papillomavirus Vaccination
CDC: HPV Educational Materials For Clinicians
What Motivates Patients to Use Telehealth?
BACKGROUND AND PURPOSE:
- Raj and Lott (American Journal of Managed Care, 2024) examined patient characteristics and motivations associated with telehealth use
METHODS:
- Cross-sectional secondary data analysis
- 2022 Health Information National Trends Survey
- Population
- A nationally representative sample of individuals both with and without cancer
- Study design
- Included only those observations where complete information for measures of interest were available
- Logistic regression models were used to estimate the relationship between demographic and health characteristics and outcomes
- Primary outcomes
- Use of telehealth services in the previous 12 months
- Motivations for using telehealth
RESULTS:
- 6252 respondents
- The most common reason for using telehealth was
- Recommendation or requirement by a clinician: 73.6%
- Respondents with depression were more likely to use telehealth
- Odds ratio (OR) 2.73 | P<0.001
- These patients were more likely to be motivated by convenience
- OR 1.80 | P<0.01
- Hispanic respondents were more likely to use telehealth to avoid exposure to infection
- OR 1.58 | P<0.05
CONCLUSION:
- Most patients who used telehealth did so because their clinician recommended or required it
- The authors state
Being female; having health insurance, multiple physical health conditions, depression, and more education; and residing in a metropolitan area were associated with a greater likelihood of using telehealth
Given that nearly two-thirds of respondents in this study did not have a telehealth visit in the previous 12 months, it is possible that further study of telehealth’s value—distinct from its utility through the pandemic—is required
Learn More – Primary Sources:
What Motivates Patients to Use Telehealth?
BACKGROUND AND PURPOSE:
- Raj and Lott (American Journal of Managed Care, 2024) examined patient characteristics and motivations associated with telehealth use
METHODS:
- Cross-sectional secondary data analysis
- 2022 Health Information National Trends Survey
- Population
- A nationally representative sample of individuals both with and without cancer
- Study design
- Included only those observations where complete information for measures of interest were available
- Logistic regression models were used to estimate the relationship between demographic and health characteristics and outcomes
- Primary outcomes
- Use of telehealth services in the previous 12 months
- Motivations for using telehealth
RESULTS:
- 6252 respondents
- The most common reason for using telehealth was
- Recommendation or requirement by a clinician: 73.6%
- Respondents with depression were more likely to use telehealth
- Odds ratio (OR) 2.73 | P<0.001
- These patients were more likely to be motivated by convenience
- OR 1.80 | P<0.01
- Hispanic respondents were more likely to use telehealth to avoid exposure to infection
- OR 1.58 | P<0.05
CONCLUSION:
- Most patients who used telehealth did so because their clinician recommended or required it
- The authors state
Being female; having health insurance, multiple physical health conditions, depression, and more education; and residing in a metropolitan area were associated with a greater likelihood of using telehealth
Given that nearly two-thirds of respondents in this study did not have a telehealth visit in the previous 12 months, it is possible that further study of telehealth’s value—distinct from its utility through the pandemic—is required
Learn More – Primary Sources:
Does the Recombinant Shingle Vaccine Reduce the Risk of Dementia in Older People?
BACKGROUND AND PURPOSE:
- Evidence suggests that the live herpes zoster (shingles) vaccine may reduce the risk of dementia in older patients
- However, the live vaccine has been retired in the US and it is not known whether the recombinant vaccine may have the same effect
- Taquet et al. (Nature Medicine, 2024) compared the risk of dementia between vaccine types
METHODS:
- Propensity score matched retrospective cohort study
- EHR data from the TriNetX US Collaborative Network
- 62 healthcare organizations
- >100 million patients
- Population
- Individuals in the US who received the shingles vaccine
- Exposures
- Earlier cohort: Received first vaccine dose between 2014 and 2017
- 98% live vaccine
- Later cohort: received first vaccine dose between 2017 and 2020
- 95% recombinant vaccine
- Earlier cohort: Received first vaccine dose between 2014 and 2017
- Primary outcome
- Dementia
RESULTS:
- Earlier cohort: 103,837 individuals | Later cohort: 103,837 individuals
- Individuals in the group that predominantly received the recombinant vaccine were at a lower risk of developing dementia over the next 6 years compared to those that received the live vaccine
- Restricted mean time lost (RMTL) ratio 0.83 (95% CI, 0.80 to 0.87) | P<0.0001
- The association was found consistently across dementia subcategories, except for frontotemporal and Lewy body dementia
- There was no difference in all-cause mortality
- Both shingles vaccines were associated with a lower risk of dementia than were the influenza and tetanus–diphtheria–pertussis vaccines
- RMTL ratios 0.73 to 0.86 | All P<0.0001
- The effect was robust across multiple secondary analyses, and was present in both men and women but was greater in women
CONCLUSION:
- Receipt of the recombinant shingles vaccine is associated with a lower risk of dementia compared to those who received the live vaccine
- The authors state
Compared with the live vaccine, receiving the recombinant shingles vaccine is associated with a lower risk of developing dementia within the next 6 years
An increase by 17% in time lived without a dementia diagnosis (or 164 additional days among those later affected) is clinically meaningful and a particularly large effect size given that the live shingles vaccine is itself associated with a lower risk of dementia, as replicated here
Learn More – Primary Sources:
The recombinant shingles vaccine is associated with lower risk of dementia
How to Say Goodbye to Your Medical Practice
Perhaps you have reached the day when you have decided to close your practice. Closing out a practice (or selling one) can be a daunting task. However, planning and inclusion of the appropriate professionals with sufficient lead time can make the process less hectic. Some necessary partners include patients, payers, vendors, employees, licensing boards and federal and state agencies. Getting legal advice is important for either a sale or complete closure. Each state where you maintain a license will have different procedures as to patient notification and medical record retention or transfer. The malpractice carriers also have a say. The list below discusses some of the key steps to take.
- Talk to your staff – Your staff should hear the news from you first, not anyone else. You can help with the transition to new employment either through a sale or closing. They will have questions regarding their salaries, benefits, and retirement plans.
- Notify your patients – Send your patients a letter notifying them of your intent to close the practice. Let them know where their records will be kept and who to contact for a copy.
- Review your insurance contracts – business insurance, workers compensation, and other carriers need notice. If you have an agent, talk to the agent about the termination process.
- Speak to your malpractice carrier- the malpractice carrier will discuss options about tail coverage, which can allow an insured physician the option to extend coverage after cancellation or termination of a claims-made policy. The carrier may also have requirements about patient notification.
- Contact hospitals where you have admitting privileges. The hospital may have a formal process to be followed.
- Reach out to your landlord – review your leasing agreement and discuss steps to terminate the lease.
- Notify referring physicians of when you plan to close your practice, so they don’t send new patients after that date.
- Contact the Drug Enforcement Agency to deactivate your license if you plan not to write another prescription and after you have safely disposed of prescription drugs following the federal guidelines. Destroy all prescription pads and contact drug representatives to determine what to do with unused samples, if needed.
- Inventory drugs – you will need to dispose, sell, transfer, or donate according to federal and state requirements. Contact the Drug Enforcement Administration (DEA) for specifics.
- Notify all vendors. Inform medical suppliers, office suppliers, collection agencies, laundry services, housekeeping services, hazardous waste disposal services, and any other vendors. Make sure to request a final statement from them so you can close your accounts.
- Process your accounts receivable to collect money owed to you. Consider employing a collection agency or staff member to reconcile accounts after the practice has closed.
- Take a deep breath – focus on your next phase in life.
This checklist is not meant to be all-inclusive. Speak to all relevant professionals such as attorneys, insurers, and accountants to ensure all obligations are met. Several specialty organizations provide checklists that can serve as a guide.
Resources
AAFP: Closing Your Practice Checklist
From Geraniums to Guadalajara on the Virtues of Early Retirement
Does Drinking Coffee Help Counteract the Harms of a Sedentary Lifestyle?
BACKGROUND AND PURPOSE:
- Zhou et al. (BMC Public Health, 2024) evaluated the independent and joint associations of daily sitting time and coffee intakes with mortality from all-cause and cardiovascular disease (CVD) among US adults
METHODS:
- Prospective cohort study
- National Health and Nutrition Examination Survey (NHANES) Survey
- 2007 to 2018
- Participants
- US adults
- Exposures
- Daily sitting time
- Coffee consumption per 24-hour period
- Study design
- Adjusted hazard ratio (HR) calculated using Cox proportional hazards regression
- Primary outcomes
- All-cause mortality
- CVD mortality
RESULTS:
- 10,639 participants
- Deaths 945 | Deaths from CVD: 284
- Compared to those who sat <4 h/d, sitting more than 8 h/d was associated with higher risks of mortality
- All-cause mortality: HR 1.46 (95% CI, 1.17 to 1.81)
- CVD mortality: HR 1.79 (95% CI, 1.21 to 2.66)
- Compared with non-coffee drinkers, people in the highest quartile of coffee consumption had reduced risks of mortality
- All-cause: HR 0.67 (95% CI, 0.54 to 0.84)
- CVD mortality: HR 0.46 (95% CI, 0.30 to 0.69)
- Compared to coffee drinkers who sat for <6h/d, sedentary non-coffee drinkers had a higher risk of all-cause mortality while sedentary coffee drinkers did not
- Sedentary non-coffee drinkers: HR 1.58 (95% CI, 1.25 to 1.99)
- Sedentary coffee drinkers: HR 1.22 (95% CI, 0.97 to 1.54)
CONCLUSION:
- Risk of all-cause and CVD mortality is higher among individuals leading a sedentary lifestyle, but risk was reduced among coffee drinkers
- The authors state
Notably, the results of a joint analysis of this study identified that that the association of sedentary with increased mortality was only observed among adults with no coffee consumption but not among those who had coffee intake
Given that coffee is a complex compound, further research is needed to explore this miracle compound
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Is Cannabis Use Linked to Worse COVID-19 Outcomes?
BACKGROUND AND PURPOSE:
- Smoking cigarettes is associated with worse COVID-19 outcomes, but it is unclear whether cannabis is also associated with poorer COVID-19 outcomes
- Griffith et al. (JAMA Network Open, 2024) examined adverse COVID-19 outcomes associated with cannabis and tobacco use
METHODS:
- Retrospective cohort study
- Extracted EHR data
- Large US midwestern academic medical center
- Population
- Patients with COVID-19
- Exposures
- Current tobacco smoking
- Current cannabis use
- Study design
- Multivariable modeling used to calculated odds ratio (OR)
- Adjustment for
- Tobacco smoking | Vaccination | Comorbidity | Diagnosis date | Demographic factors
- Primary outcomes
- Health outcomes of hospitalization
- ICU admission
- All-cause mortality following COVID-19 infection
RESULTS:
- 72,501 patients with COVID-19
- Current smoking: 13.4% | Former smoking: 24.4%
- Current cannabis use: 9.7%
- For patients with COVID-19, current tobacco smoking was associated with an increased risk of
- Hospitalization: OR 1.72 (95% CI, 1.62 to 1.82) | P<0.001
- ICU admission: OR 1.22 (95% CI, 1.10 to 1.34) | P<0.001
- All-cause mortality: OR 1.37 (95% CI, 1.30 to 1.57) | P<0.001
- Cannabis use was associated with an increased risk of
- Hospitalization: OR 1.80 (95% CI, 1.68 to 1.93) | P<0.001
- ICU admission: OR 1.27 (95% CI, 1.14 to 1.41) | P<0.001
- Cannabis use was not associated with all-cause mortality
- OR 0.97 (95% CI, 0.81 to 1.14) | P=0.69
CONCLUSION:
- Tobacco smoking is linked to an increased risk of poorer COVID-19 outcomes
- Cannabis use also appears to be a risk factor for worse COVID-19 outcomes
- The authors state
Given the recent legalization of recreational marijuana use in more states, including the area served by this academic medical center, further research may aid in guiding interventions, such as substance use prevention and treatment, that would benefit patient outcomes moving forward in the COVID-19 pandemic and the associated heath consequences it will have in our communities
Learn More – Primary Sources:
Cannabis, Tobacco Use, and COVID-19 Outcomes
Do Fish Oil Supplements Impact Cardiovascular Health?
BACKGROUND AND PURPOSE:
- Data on fish oil supplements, and their role in cardiovascular disease, are controversial
- Chen et al. (BMJ Medicine, 2024) examined the effects of fish oil supplements on the clinical course of cardiovascular disease across disease states
METHODS:
- Prospective cohort study
- UK Biobank study
- Participants
- Adults aged 40 to 69
- Exposures
- Fish oil supplements
- Stage of cardiovascular disease
- Healthy (primary stage) | Atrial fibrillation (secondary stage) | Major cardiovascular events (tertiary stage) | Death
- Primary outcomes
- Incident cases of atrial fibrillation | Major adverse cardiovascular events | Death
RESULTS:
- Healthy starting population: 415,737
- Median follow-up 11.9 years
- Progressed to
- Atrial fibrillation: 18,367 | Major cardiovascular events: 22,636 | Death: 22,140
- For healthy participants, fish oil was associated with a greater incidence of atrial fibrillation and stroke
- Atrial fibrillation: Hazard Ratio HR) 1.13 (95% CI, 1.10 to 1.17)
- Stroke: HR 1.05 (95% CI, 1.00 to 1.11)
- For patients with a diagnosis of cardiovascular disease, regular use of fish oil was beneficial in reducing transitions from
- Atrial fibrillation to major cardiovascular events: HR 0.92 (95% CI, 0.87 to 0.98)
- Atrial fibrillation to myocardial infarction: HR 0.85 (95% CI, 0.76 to 0.96)
- Heart failure to death: HR 0.91 (95% CI, 0.84 to 0.99)
CONCLUSION:
- In the general healthy population, regular use of fish oil supplements may increase the risk of atrial fibrillation and stroke
- For those with cardiovascular disease, fish oil supplements may be beneficial at reducing the risk of transitioning to worse cardiovascular states
- The authors state
When we divided major adverse cardiovascular events into three individual diseases (ie, heart failure, stroke, and myocardial infarction), we found associations that could suggest a mildly harmful effect between regular use of fish oil supplements and transitions from a healthy cardiovascular state to stroke, whereas potential beneficial associations were found between regular use of fish oil supplements and transitions from atrial fibrillation to myocardial infarction, atrial fibrillation to death, and heart failure to death
Learn More – Primary Sources:
Regular use of fish oil supplements and course of cardiovascular diseases: prospective cohort study
Meta-Analysis: What are the “Red Flag” Signs of Early Onset Colorectal Cancer?
BACKGROUND AND PURPOSE:
- Rate of early-onset colorectal cancer (EOCRC; defined as diagnosis <50 years) is increasing
- Demb et al. (JAMA Network Open, 2024) sought to determine the frequency of presenting red flag signs and symptoms among individuals with EOCRC
METHODS:
- Systematic review and meta-analysis
- Study inclusion criteria
- Patients <50 years diagnosed with nonhereditary CRC
- Reported on sign and symptom presentation or time from sign and symptom presentation to diagnosis
- Study design
- Quality of the included studies and risk of bias was measured
- Data on frequency of signs and symptoms were pooled using a random-effects model
- Primary outcomes
- Pooled proportions of signs and symptoms in patients with EOCRC
- Estimates for association of signs and symptoms with EOCRC risk
- Time from sign or symptom presentation to EOCRC diagnosis
RESULTS:
- 81 studies | 24,908,126 patients <50
- Most common presenting signs and symptoms (78 studies)
- Hematochezia: pooled prevalence 45% (95% CI, 40 to 50)
- Abdominal pain: pooled prevalence 40% (95% CI, 35 to 45)
- Altered bowel habits: pooled prevalence 27% (95% CI, 22 to 33)
- The signs and symptoms with the greatest association with EOCRC likelihood were
- Hematochezia: estimate range 5.2 to 54.0
- Abdominal pain: estimate range 1.3 to 6.0
- Anemia: estimate range 2.1 to 10.8
- Time from signs and symptoms presentation to EOCRC diagnosis
- Mean 6.4 (range 1.8 to 13.7) months | 23 studies
- Median 4 (range 2.0 to 8.7) months | 16 studies
CONCLUSION:
- For patients with early onset colorectal cancer, the most common signs and symptoms were hematochezia and abdominal pain (nearly half of all patients) and altered bowel habits (over a quarter of all patients)
- Hematochezia was associated with the highest risk of EOCRC
- Delays in diagnosis were common, and were generally on the order of 4 to 6 months
- The authors state
These findings and the increasing risk of CRC in individuals younger than 50 years highlight the urgent need to educate clinicians and patients about these signs and symptoms to ensure that diagnostic workup and resolution are not delayed
Adapting current clinical practice to identify and address these signs and symptoms through careful clinical triage and follow-up could help limit morbidity and mortality associated with EOCRC
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What is the Most Trusted Source of Health Information in the US?
BACKGROUND AND PURPOSE:
- Suran and Bucher (JAMA, 2024) review important survey data that ascertained where individuals in the US get their news and the which health information sources they trust
METHODS:
- Survey of a nationally representative sample of Black, Hispanic and White US adults
RESULTS:
- Trust in health professionals was high, and crossed party lines
- 95% of both Republicans and Democrats reported that they trusted their personal physicians to provide accurate recommendations on health issues
- Trust in the government was lower, but still relatively high, but varied more across party lines
- Trust in CDC
- Republicans: 49% | Democrats: 87%
- Trust in state and local public health officials
- Republicans: 58% | Democrats: 74%
- Trust in CDC
- The vast majority (96%) of respondents reported hearing at least one of the 10 false claims presented by the survey
- e.g. that the MMR vaccine causes autism
- While knowledge of misinformation was high, the percentage of people that believed false claims was generally lower: 14 to 35%
- Most respondents (74%) were concerned about the spread of false health claims
- Desire for Congress and President Joe Biden to do more: 68 to 78%
- Desire for US news media to do more: 70%
- Social media use was high, but most people reported not trusting the health information on platforms
- Users who visited Facebook weekly: 63% | Users who trust health claims on Facebook: 5%
- Use of local and national news media was also high, and respondents reported a greater trust in health information from these sources
- Local news watchers: 62%
- Watchers who have “a lot” of trust in health claims on local news: 37%
CONCLUSION:
- Most adults are aware that there are a lot of false health claims circulating on social media, and through society in general
- Despite many respondents having heard these claims, far fewer actually believe them
- The most trusted source for health information was respondent’s personal physician
Learn More – Primary Sources:
False Health Claims Abound, but Physicians Are Still the Most Trusted Source for Health Information
